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A Study to Evaluate the Safety and Tolerability of MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Participants With Moderate to Severe Atopic Dermatitis (GECKO)

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ClinicalTrials.gov Identifier: NCT03864627
Recruitment Status : Terminated (MOR106 clinical development in atopic dermatitis was stopped for futility)
First Posted : March 6, 2019
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: MOR106
Drug: Placebo
Enrollment 33
Recruitment Details Participants were enrolled at study sites in the United States. The first participant was screened on 25 Mar 2019. The last study visit occurred on 27 Feb 2020.
Pre-assignment Details A total of 76 participants were screened of which 33 participants were randomized into the study.
Arm/Group Title Placebo MOR106 320 mg
Hide Arm/Group Description Participants received MOR106 matching placebo via subcutaneous (s.c.) injection every other week on Day 1, 15, 29 and 43 given concomitantly with medium potency topical corticosteroid (TCS) once daily until Day 57. Participants received MOR106 320 milligrams (mg) via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection was administered on Day 1.
Period Title: Overall Study
Started 11 22
Completed 7 10
Not Completed 4 12
Reason Not Completed
Adverse Event             0             1
Lack of Efficacy             0             1
Lost to Follow-up             0             1
Withdrawal by Subject             4             8
Study terminated by sponsor             0             1
Arm/Group Title Placebo MOR106 320 mg Total
Hide Arm/Group Description Participants received MOR106 matching placebo via s.c. injection every other week on Day 1, 15, 29 and 43 given concomitantly with medium potency TCS once daily until Day 57. Participants received MOR106 320 mg via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection was administered on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 11 22 33
Hide Baseline Analysis Population Description
The safety analysis set included all participants who received at least one dose of investigational medicinal product (IMP).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 22 participants 33 participants
39.8  (17.85) 36.1  (13.34) 37.4  (14.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 22 participants 33 participants
Female 7 11 18
Male 4 11 15
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 22 participants 33 participants
Hispanic or Latino 5 11 16
Not Hispanic or Latino 6 11 17
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 22 participants 33 participants
American Indian or Alaska Native 0 0 0
Asian 1 5 6
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 1 2 3
White 9 15 24
More than one race 0 0 0
Unknown or Not Reported 0 0 0
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs)
Hide Description An Adverse Events (AE) was any untoward medical occurrence, new or worsening of any pre-existing condition, in a clinical study participant administered a medicinal product and which did not necessarily had to have a causal relationship with the treatment. TEAEs: AES with an onset date on or after the start date of the IMP administration. AESIs: skin-related events (SRE) (except exacerbation and infective exacerbation of AD) or injection site reactions (ISRs) as per common terminology criteria for AEs (Grade 3: ulceration or necrosis; severe tissue damage; operative intervention indicated, Grade 4: life-threatening consequences; urgent intervention indicated, Grade 5: death ). An SAE: AE that resulted in any of the following outcomes: death; life threatening; results in persistent or significant disability/incapacity; requires in-patient hospitalization or prolongation of existing hospitalization; congenital anomaly/birth defect; is medically significant.
Time Frame Day 1 up to Day 169/Early discontinuation(ED)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set included all participants who received at least one dose of IMP.
Arm/Group Title Placebo MOR106 320 mg
Hide Arm/Group Description:
Participants received MOR106 matching placebo via s.c. injection every other week on Day 1, 15, 29 and 43 given concomitantly with medium potency TCS once daily until Day 57.
Participants received MOR106 320 mg via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection was administered on Day 1.
Overall Number of Participants Analyzed 11 22
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE 5 11
AESI: SRE 2 1
AESI: ISRs 0 0
SAE 0 1
2.Secondary Outcome
Title Serum Concentrations of MOR106
Hide Description [Not Specified]
Time Frame Day 1, Day 4, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141, Day 155 and Day 169
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis population was a subset of safety analysis set and included all participants who had available and evaluable serum concentration data. Participants in PK population with available data at specified timepoint.
Arm/Group Title MOR106 320 mg
Hide Arm/Group Description:
Participants received MOR106 320 mg via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection was administered on Day 1.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: microgram per milliliter (µg/mL)
Day 1 Number Analyzed 20 participants
0.149  (0.2505)
Day 4 Number Analyzed 18 participants
61.150  (28.3850)
Day 15 Number Analyzed 18 participants
41.278  (21.4046)
Day 29 Number Analyzed 15 participants
39.473  (15.8087)
Day 43 Number Analyzed 10 participants
42.537  (23.8095)
Day 57 Number Analyzed 11 participants
40.934  (17.6737)
Day 71 Number Analyzed 9 participants
16.593  (7.3308)
Day 85 Number Analyzed 6 participants
9.775  (3.2489)
Day 99 Number Analyzed 6 participants
5.092  (1.0801)
Day 113 Number Analyzed 6 participants
2.415  (1.3466)
Day 127 Number Analyzed 9 participants
1.407  (0.8124)
Day 141 Number Analyzed 7 participants
1.812  (2.4765)
Day 155 Number Analyzed 6 participants
1.043  (1.2149)
Day 169 Number Analyzed 7 participants
0.690  (0.9707)
3.Secondary Outcome
Title Number of Participants With Anti-drug Antibodies (ADAs)
Hide Description [Not Specified]
Time Frame Day 1 up to Day 169/ED
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set.
Arm/Group Title Placebo MOR106 320 mg
Hide Arm/Group Description:
Participants received MOR106 matching placebo via s.c. injection every other week on Day 1, 15, 29 and 43 given concomitantly with medium potency TCS once daily until Day 57.
Participants received MOR106 320 mg via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection was administered on Day 1.
Overall Number of Participants Analyzed 11 22
Measure Type: Count of Participants
Unit of Measure: Participants
0 0
Time Frame Day 1 up to Day 169/ED
Adverse Event Reporting Description Safety analysis set.
 
Arm/Group Title Placebo MOR106 320 mg
Hide Arm/Group Description Participants received MOR106 matching placebo via s.c. injection every other week on Day 1, 15, 29 and 43 given concomitantly with medium potency TCS once daily until Day 57. Participants received MOR106 320 mg via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection was administered on Day 1.
All-Cause Mortality
Placebo MOR106 320 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/22 (0.00%) 
Hide Serious Adverse Events
Placebo MOR106 320 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   1/22 (4.55%) 
Gastrointestinal disorders     
Gastric ulcer  1  0/11 (0.00%)  1/22 (4.55%) 
General disorders     
Pyrexia  1  0/11 (0.00%)  1/22 (4.55%) 
Infections and infestations     
Pneumonia  1  0/11 (0.00%)  1/22 (4.55%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hodgkin's disease  1  0/11 (0.00%)  1/22 (4.55%) 
1
Term from vocabulary, MedDRA Version 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo MOR106 320 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   5/11 (45.45%)   11/22 (50.00%) 
Cardiac disorders     
Atrioventricular block first degree  1  0/11 (0.00%)  1/22 (4.55%) 
Tachycardia  1  0/11 (0.00%)  1/22 (4.55%) 
General disorders     
Injection site reaction  1  1/11 (9.09%)  2/22 (9.09%) 
Infections and infestations     
Folliculitis  1  1/11 (9.09%)  1/22 (4.55%) 
Nasopharyngitis  1  1/11 (9.09%)  0/22 (0.00%) 
Upper respiratory tract infection  1  1/11 (9.09%)  0/22 (0.00%) 
Injury, poisoning and procedural complications     
Arthropod bite  1  0/11 (0.00%)  1/22 (4.55%) 
Foot fracture  1  0/11 (0.00%)  1/22 (4.55%) 
Metabolism and nutrition disorders     
Hyperuricaemia  1  1/11 (9.09%)  0/22 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma  1  1/11 (9.09%)  0/22 (0.00%) 
Nervous system disorders     
Burning sensation  1  0/11 (0.00%)  1/22 (4.55%) 
Headache  1  0/11 (0.00%)  1/22 (4.55%) 
Presyncope  1  0/11 (0.00%)  1/22 (4.55%) 
Skin and subcutaneous tissue disorders     
Skin exfoliation  1  1/11 (9.09%)  0/22 (0.00%) 
Miliaria  1  0/11 (0.00%)  1/22 (4.55%) 
1
Term from vocabulary, MedDRA Version 23.0
Indicates events were collected by systematic assessment
The study was terminated as MOR106, clinical development in atopic dermatitis was stopped for futility.
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 sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Galapagos Medical Information
Organization: Galapagos NV
Phone: +32 15 342900
EMail: medicalinfo@glpg.com
Layout table for additonal information
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT03864627    
Other Study ID Numbers: MOR106-CL-204
First Submitted: March 5, 2019
First Posted: March 6, 2019
Results First Submitted: December 8, 2020
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021