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Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema

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ClinicalTrials.gov Identifier: NCT03683719
Recruitment Status : Completed
First Posted : September 25, 2018
Results First Posted : April 19, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Hand Eczema
Interventions Drug: Delgocitinib cream
Drug: Delgocitinib cream vehicle
Enrollment 258
Recruitment Details 258 participants from 26 sites in 3 countries (U.S., Denmark, Germany) were randomised in this trial. The first participant was screened on 28-Nov-2018 and the last participant completed the trial on 20-Apr-2020.
Pre-assignment Details 305 participants were screened for this trial. Of these, 47 participants (15.4%) were screening failures. The main reason for screening failure was failure to meet eligibility criteria (11.8%). The eligibility criterion that was most frequently not met was exclusion criterion 21 (positive HBsAg, HBsAb, HBcAb, or antiHCV serology at screening [3.3%]).
Arm/Group Title Delgocitinib Cream 1 mg/g Delgocitinib Cream 3 mg/g Delgocitinib Cream 8 mg/g Delgocitinib Cream 20 mg/g Delgocitinib Cream Vehicle
Hide Arm/Group Description

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream vehicle applied twice daily for 16 weeks.

Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Period Title: Overall Study
Started 52 51 52 53 50
Completed 40 38 44 46 36
Not Completed 12 13 8 7 14
Reason Not Completed
Lack of Efficacy             1             3             4             0             4
Adverse Event             6             6             0             1             3
Withdrawal by Subject             4             4             3             5             5
Lost to Follow-up             1             0             0             1             1
Other personal reasons             0             0             1             0             1
Arm/Group Title Delgocitinib Cream 1 mg/g Delgocitinib Cream 3 mg/g Delgocitinib Cream 8 mg/g Delgocitinib Cream 20 mg/g Delgocitinib Cream Vehicle Total
Hide Arm/Group Description

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream vehicle applied twice daily for 16 weeks.

Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Total of all reporting groups
Overall Number of Baseline Participants 52 51 52 53 50 258
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 51 participants 52 participants 53 participants 50 participants 258 participants
44.3  (13.6) 46.1  (14.6) 47.9  (12.9) 43.9  (15.1) 47.8  (16.2) 46.0  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 52 participants 53 participants 50 participants 258 participants
Female
37
  71.2%
28
  54.9%
32
  61.5%
34
  64.2%
27
  54.0%
158
  61.2%
Male
15
  28.8%
23
  45.1%
20
  38.5%
19
  35.8%
23
  46.0%
100
  38.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 52 participants 53 participants 50 participants 258 participants
Hispanic or Latino
3
   5.8%
0
   0.0%
2
   3.8%
1
   1.9%
3
   6.0%
9
   3.5%
Not Hispanic or Latino
49
  94.2%
51
 100.0%
50
  96.2%
52
  98.1%
47
  94.0%
249
  96.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 52 participants 51 participants 52 participants 53 participants 50 participants 258 participants
White
51
  98.1%
51
 100.0%
50
  96.2%
52
  98.1%
50
 100.0%
254
  98.4%
Asian
1
   1.9%
0
   0.0%
1
   1.9%
1
   1.9%
0
   0.0%
3
   1.2%
Other
0
   0.0%
0
   0.0%
1
   1.9%
0
   0.0%
0
   0.0%
1
   0.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 52 participants 53 participants 50 participants 258 participants
United States 4 4 4 5 4 21
Denmark 12 7 12 11 16 58
Germany 36 40 36 37 30 179
Baseline IGA-CHE score  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 52 participants 53 participants 50 participants 258 participants
0 - Clear
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1 - Almost clear
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2 - Mild
13
  25.0%
13
  25.5%
11
  21.2%
12
  22.6%
12
  24.0%
61
  23.6%
3 - Moderate
29
  55.8%
29
  56.9%
29
  55.8%
31
  58.5%
27
  54.0%
145
  56.2%
4 - Severe
10
  19.2%
9
  17.6%
12
  23.1%
10
  18.9%
11
  22.0%
52
  20.2%
Baseline HECSI score  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 52 participants 51 participants 52 participants 53 participants 50 participants 258 participants
59.0  (48.0) 52.4  (35.9) 49.5  (29.3) 65.7  (58.3) 52.7  (34.9) 55.9  (42.8)
1.Primary Outcome
Title Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-step Improvement (IGA-CHE Treatment Success) From Baseline to Week 16.
Hide Description

IGA-CHE is an instrument used in clinical trials to rate the severity of subject's global disease stage and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).

The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. Cochran-Mantel-Haenszel analysis was used to determine the difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle.

Time Frame Week 0 to Week 16.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Delgocitinib Cream 1 mg/g Delgocitinib Cream 3 mg/g Delgocitinib Cream 8 mg/g Delgocitinib Cream 20 mg/g Delgocitinib Cream Vehicle
Hide Arm/Group Description:

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream vehicle applied twice daily for 16 weeks.

Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Overall Number of Participants Analyzed 52 51 52 53 50
Measure Type: Count of Participants
Unit of Measure: Participants
11
  21.2%
4
   7.8%
19
  36.5%
20
  37.7%
4
   8.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 1 mg/g, Delgocitinib Cream 3 mg/g, Delgocitinib Cream 8 mg/g, Delgocitinib Cream 20 mg/g, Delgocitinib Cream Vehicle
Comments The primary endpoint was evaluated by determining if there was a dose-response relationship between the IGA-CHE response rate at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments

P-values were adjusted for multiple comparisons. Models with an adjusted p-value <0.025 were statistically sign. different from a flat dose-response model. Model: IGA-CHE TS = Treatment + Region + Baseline IGA-CHE.

Model selected: Emax model

Method Multiple contrast test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 1 mg/g, Delgocitinib Cream Vehicle
Comments The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 13.29
Confidence Interval (2-Sided) 95%
0.34 to 26.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 3 mg/g, Delgocitinib Cream Vehicle
Comments The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-10.44 to 10.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 8 mg/g, Delgocitinib Cream Vehicle
Comments The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 28.22
Confidence Interval (2-Sided) 95%
13.8 to 42.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 20 mg/g, Delgocitinib Cream Vehicle
Comments The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 29.61
Confidence Interval (2-Sided) 95%
14.56 to 44.67
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Hand Eczema Severity Index (HECSI) From Baseline to Week 16.
Hide Description

HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). The highest possible HECSI score is 360.

The multiple comparison procedure - modelling (MCP-Mod) approach was used to guide dose selection. A mixed model for repeated measurements (MMRM) analysis was used to determine the difference in the continuous endpoint between the active delgocitinib cream doses and delgocitinib cream vehicle.

Time Frame Week 0 to Week 16.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Delgocitinib Cream 1 mg/g Delgocitinib Cream 3 mg/g Delgocitinib Cream 8 mg/g Delgocitinib Cream 20 mg/g Delgocitinib Cream Vehicle
Hide Arm/Group Description:

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream vehicle applied twice daily for 16 weeks.

Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Overall Number of Participants Analyzed 52 51 52 53 50
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-39.81  (3.71) -35.93  (3.77) -46.69  (3.63) -41.99  (3.59) -26.40  (3.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 1 mg/g, Delgocitinib Cream 3 mg/g, Delgocitinib Cream 8 mg/g, Delgocitinib Cream 20 mg/g, Delgocitinib Cream Vehicle
Comments The secondary endpoint "Change from baseline to Week 16 in HECSI score" was evaluated by determining if there was a dose-response relationship between the change from baseline in HECSI score at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments

P-values were adjusted for multiple comparisons. Models with an adj. p-value <0.025 were statistically sign. different from a flat dose-response model. Model: Change = Treatment + Baseline + Region + Baseline IGA-CHE.

Model selected: Emax model

Method Multiple contrast test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 1 mg/g, Delgocitinib Cream Vehicle
Comments

Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:

Change from baseline in HECSI

= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.

The primary comparison between each active delgocitinib dose and vehicle was at Week 16.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -13.41
Confidence Interval (2-Sided) 95%
-22.82 to -4.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 3 mg/g, Delgocitinib Cream Vehicle
Comments

Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:

Change from baseline in HECSI

= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.

The primary comparison between each active delgocitinib dose and vehicle was at Week 16.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -9.53
Confidence Interval (2-Sided) 95%
-19.04 to -0.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 8 mg/g, Delgocitinib Cream Vehicle
Comments

Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:

Change from baseline in HECSI

= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.

The primary comparison between each active delgocitinib dose and vehicle was at Week 16.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -20.29
Confidence Interval (2-Sided) 95%
-29.56 to -11.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 20 mg/g, Delgocitinib Cream Vehicle
Comments

Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:

Change from baseline in HECSI

= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.

The primary comparison between each active delgocitinib dose and vehicle was at Week 16.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -15.59
Confidence Interval (2-Sided) 95%
-24.82 to -6.36
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to IGA-CHE Treatment Success.
Hide Description Time to IGA-CHE treatment success response is defined as the time from baseline to first assessment of an IGA-CHE score of 0 (clear) or 1 (almost clear) with at least a 2-step improvement.
Time Frame Week 0 to Week 16.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Delgocitinib Cream 1 mg/g Delgocitinib Cream 3 mg/g Delgocitinib Cream 8 mg/g Delgocitinib Cream 20 mg/g Delgocitinib Cream Vehicle
Hide Arm/Group Description:

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream vehicle applied twice daily for 16 weeks.

Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Overall Number of Participants Analyzed 52 51 52 53 50
Measure Type: Number
Unit of Measure: days, median
NA [1]  NA [1]  82 98 NA [1] 
[1]
The median time to achieve success in IGA-CHE was not estimable, as fewer participants (less than 50 percent) reached success in IGA-CHE.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 1 mg/g, Delgocitinib Cream Vehicle
Comments Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.
Type of Statistical Test Other
Comments Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.
Statistical Test of Hypothesis P-Value <0.05
Comments

IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable.

The statistical test was not controlled for multiplicity.

Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 3 mg/g, Delgocitinib Cream Vehicle
Comments Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.
Type of Statistical Test Other
Comments Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.
Statistical Test of Hypothesis P-Value >0.1
Comments

IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable.

The statistical test was not controlled for multiplicity.

Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 8 mg/g, Delgocitinib Cream Vehicle
Comments Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.
Type of Statistical Test Other
Comments Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.
Statistical Test of Hypothesis P-Value <0.0001
Comments The statistical test was not controlled for multiplicity.
Method Log Rank
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Delgocitinib Cream 20 mg/g, Delgocitinib Cream Vehicle
Comments Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.
Type of Statistical Test Other
Comments Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.
Statistical Test of Hypothesis P-Value <0.01
Comments The statistical test was not controlled for multiplicity.
Method Log Rank
Comments [Not Specified]
Time Frame 18 weeks (from first application of IMP up until the last visit (safety follow-up visit))
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Delgocitinib Cream 1 mg/g Delgocitinib Cream 3 mg/g Delgocitinib Cream 8 mg/g Delgocitinib Cream 20 mg/g Delgocitinib Cream Vehicle
Hide Arm/Group Description

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream applied twice daily for 16 weeks.

Delgocitinib cream: Cream for topical application.

Delgocitinib cream vehicle applied twice daily for 16 weeks.

Delgocitinib cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

All-Cause Mortality
Delgocitinib Cream 1 mg/g Delgocitinib Cream 3 mg/g Delgocitinib Cream 8 mg/g Delgocitinib Cream 20 mg/g Delgocitinib Cream Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)      0/51 (0.00%)      0/52 (0.00%)      0/53 (0.00%)      0/50 (0.00%)    
Hide Serious Adverse Events
Delgocitinib Cream 1 mg/g Delgocitinib Cream 3 mg/g Delgocitinib Cream 8 mg/g Delgocitinib Cream 20 mg/g Delgocitinib Cream Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/52 (0.00%)      2/51 (3.92%)      1/52 (1.92%)      0/53 (0.00%)      0/50 (0.00%)    
Nervous system disorders           
Dizziness postural * 1  0/52 (0.00%)  0 1/51 (1.96%)  1 0/52 (0.00%)  0 0/53 (0.00%)  0 0/50 (0.00%)  0
Psychiatric disorders           
Anxiety * 1  0/52 (0.00%)  0 0/51 (0.00%)  0 1/52 (1.92%)  1 0/53 (0.00%)  0 0/50 (0.00%)  0
Skin and subcutaneous tissue disorders           
Pemphigoid * 1  0/52 (0.00%)  0 1/51 (1.96%)  1 0/52 (0.00%)  0 0/53 (0.00%)  0 0/50 (0.00%)  0
1
Term from vocabulary, MedDRA (21.1)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Delgocitinib Cream 1 mg/g Delgocitinib Cream 3 mg/g Delgocitinib Cream 8 mg/g Delgocitinib Cream 20 mg/g Delgocitinib Cream Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/52 (38.46%)      25/51 (49.02%)      25/52 (48.08%)      26/53 (49.06%)      24/50 (48.00%)    
Gastrointestinal disorders           
Toothache * 1  3/52 (5.77%)  3 1/51 (1.96%)  1 0/52 (0.00%)  0 0/53 (0.00%)  0 0/50 (0.00%)  0
Infections and infestations           
Nasopharyngitis * 1  9/52 (17.31%)  11 15/51 (29.41%)  22 15/52 (28.85%)  16 14/53 (26.42%)  20 20/50 (40.00%)  20
Influenza * 1  1/52 (1.92%)  1 1/51 (1.96%)  1 0/52 (0.00%)  0 4/53 (7.55%)  4 0/50 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Back pain * 1  1/52 (1.92%)  1 0/51 (0.00%)  0 2/52 (3.85%)  2 3/53 (5.66%)  3 1/50 (2.00%)  1
Nervous system disorders           
Headache * 1  2/52 (3.85%)  2 2/51 (3.92%)  4 6/52 (11.54%)  7 4/53 (7.55%)  5 2/50 (4.00%)  2
Skin and subcutaneous tissue disorders           
Eczema * 1  5/52 (9.62%)  5 4/51 (7.84%)  5 3/52 (5.77%)  7 6/53 (11.32%)  7 8/50 (16.00%)  9
Pruritus * 1  3/52 (5.77%)  3 2/51 (3.92%)  2 1/52 (1.92%)  1 3/53 (5.66%)  3 1/50 (2.00%)  1
Dermatitis atopic * 1  1/52 (1.92%)  1 3/51 (5.88%)  3 0/52 (0.00%)  0 0/53 (0.00%)  0 0/50 (0.00%)  0
1
Term from vocabulary, MedDRA (21.1)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
LEO Pharma A/S seeks publication of all clinical trials in peer-reviewed journals within 18 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. After such publication is made public, or if no publication is submitted by LEO Pharma A/S within these 18 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical disclosure
Organization: LEO Pharma A/S
Phone: +45 4494 5888
EMail: disclosure@leo-pharma.com
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT03683719    
Other Study ID Numbers: LP0133-1273
First Submitted: September 21, 2018
First Posted: September 25, 2018
Results First Submitted: March 23, 2021
Results First Posted: April 19, 2021
Last Update Posted: April 19, 2021