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Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab (ARROW)

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ClinicalTrials.gov Identifier: NCT03553823
Recruitment Status : Completed
First Posted : June 12, 2018
Results First Posted : February 25, 2021
Last Update Posted : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Plaque-type Psoriasis
Intervention Procedure: Skin biopsies
Enrollment 40
Recruitment Details The Screening Phase was completed by 40 (95.2%) of the 42 subjects screened. One (2.4%) subject was rescreened and 2 (4.8%) subjects failed screening
Pre-assignment Details 39 (97.5%) subjects completed this trial
Arm/Group Title Secukinumab Guselkumab
Hide Arm/Group Description 20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive 20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12.
Period Title: Overall Study
Started 20 20
Completed 20 19
Not Completed 0 1
Reason Not Completed
Physician Decision             0             1
Arm/Group Title Secukinumab Guselkumab Total
Hide Arm/Group Description 20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive 20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12. Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  85.0%
19
  95.0%
36
  90.0%
>=65 years
3
  15.0%
1
   5.0%
4
  10.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
47.6  (15.10) 48.5  (12.30) 48.1  (13.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
6
  30.0%
5
  25.0%
11
  27.5%
Male
14
  70.0%
15
  75.0%
29
  72.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
White
17
  85.0%
20
 100.0%
37
  92.5%
Black or African American
2
  10.0%
0
   0.0%
2
   5.0%
Asian
1
   5.0%
0
   0.0%
1
   2.5%
1.Primary Outcome
Title Proportion of Subjects Whose Plaque Achieves "Clear" or "Almost Clear" Status (TCS = 0-2)
Hide Description Total clinical score: number (%) of subjects who responded at Week 16 (FAS)
Time Frame 16 week
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) comprised all subjects to whom study treatment had been assigned by randomization. According to the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to during the randomization procedure.
Arm/Group Title Secukinumab Guselkumab
Hide Arm/Group Description:
20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered 300 mg secukinumab as two 150-mg s.c. injections at Baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 12 inclusive
20 subjects with plaque psoriasis with an inadequate response to ustekinumab self-administered guselkumab as 100 mg s.c. injections at Baseline, Weeks 4, and 12.
Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
12
  60.0%
8
  40.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Secukinumab, Guselkumab
Comments Proportion of subjects whose plaque achieves "clear" or "almost clear" status (TCS = 0-2)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1715
Comments [Not Specified]
Method Fisher Exact
Comments The statistical model was the Fisher's exact test for the difference in proportions.
Method of Estimation Estimation Parameter Difference secukinumab vs guselkumab
Estimated Value 20.0
Confidence Interval (2-Sided) 95%
-13.3 to 50.3
Estimation Comments [Not Specified]
Time Frame Adverse Events were collected for duration of study to week 16
Adverse Event Reporting Description Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment period
 
Arm/Group Title Secukinumab Guselkumab
Hide Arm/Group Description Secukinumab Guselkumab
All-Cause Mortality
Secukinumab Guselkumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
Secukinumab Guselkumab
Affected / at Risk (%) Affected / at Risk (%)
Total   2/20 (10.00%)   1/20 (5.00%) 
Gastrointestinal disorders     
Gastritis  1  1/20 (5.00%)  0/20 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/20 (0.00%)  1/20 (5.00%) 
Infections and infestations     
Pneumonia  1  1/20 (5.00%)  0/20 (0.00%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Secukinumab Guselkumab
Affected / at Risk (%) Affected / at Risk (%)
Total   11/20 (55.00%)   5/20 (25.00%) 
Eye disorders     
Dacryostenosis acquired  1  1/20 (5.00%)  0/20 (0.00%) 
Infections and infestations     
Bronchitis  1  0/20 (0.00%)  1/20 (5.00%) 
Erysipelas  1  1/20 (5.00%)  0/20 (0.00%) 
Herpes zoster  1  1/20 (5.00%)  0/20 (0.00%) 
Nasopharyngitis  1  2/20 (10.00%)  1/20 (5.00%) 
Postoperative wound infection  1  1/20 (5.00%)  0/20 (0.00%) 
Sepsis  1  1/20 (5.00%)  0/20 (0.00%) 
Vulvovaginal mycotic infection  1  1/20 (5.00%)  0/20 (0.00%) 
Injury, poisoning and procedural complications     
Wound dehiscence  1  1/20 (5.00%)  0/20 (0.00%) 
Investigations     
Blood bilirubin increased  1  1/20 (5.00%)  0/20 (0.00%) 
Metabolism and nutrition disorders     
Gout  1  2/20 (10.00%)  0/20 (0.00%) 
Hyperglycaemia  1  1/20 (5.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/20 (0.00%)  1/20 (5.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/20 (5.00%)  0/20 (0.00%) 
Reproductive system and breast disorders     
Balanoposthitis  1  1/20 (5.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/20 (5.00%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders     
Dyshidrotic eczema  1  0/20 (0.00%)  1/20 (5.00%) 
Eczema  1  0/20 (0.00%)  1/20 (5.00%) 
Hyperhidrosis  1  0/20 (0.00%)  1/20 (5.00%) 
Miliaria  1  1/20 (5.00%)  0/20 (0.00%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Analysis of biomarkers is delayed due to the global coronavirus pandemic of 2020, thus, the biomarker-related exploratory objectives were not evaluated in this present report; but will be presented in a voluntary future update.
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT03553823    
Other Study ID Numbers: CAIN457A2403
2018-001048-70 ( EudraCT Number )
First Submitted: May 15, 2018
First Posted: June 12, 2018
Results First Submitted: January 21, 2021
Results First Posted: February 25, 2021
Last Update Posted: October 11, 2021