A Study to Test Safety and Tolerability of a Study Drug Called MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Patients 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
Last Update Posted : March 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: MOR106 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Multicentre Phase 2 Study to Evaluate the Safety and Tolerability of Subcutaneous MOR106 Administered Concomitantly With Topical Corticosteroids for Eight Weeks, in Adult Subjects With Moderate to Severe Atopic Dermatitis|
|Actual Study Start Date :||March 25, 2019|
|Actual Primary Completion Date :||February 27, 2020|
|Actual Study Completion Date :||February 27, 2020|
Experimental: MOR106 and TCS
Repeated s.c. doses of MOR106, administered concomitantly with TCS (medium potency). On Day 1 a loading dose (LD) will be administered.
MOR106 liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).
Placebo Comparator: Placebo and TCS
Repeated s.c. doses of placebo, administered concomitantly with TCS (medium potency). On Day 1 a loading dose (LD) will be administered (placebo).
Placebo liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).
- The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) [ Time Frame: From screening up through Day 169 or early discontinuation (ED) visit ]To investigate the safety and tolerability of repeated subcutaneous (s.c.) doses of MOR106 administered concomitantly with topical corticosteroids (TCS) in subjects with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
- MOR106 serum concentrations after repeated s.c. administrations [ Time Frame: From baseline through Day 169 or ED visit ]To evaluate the pharmacokinetics (PK) of repeated s.c. doses of MOR106 administered concomitantly with TCS.
- Occurrence of anti-drug antibodies (ADA) [ Time Frame: From baseline through Day 169 or ED visit ]To monitor the occurrence ADA as a measure of immunogenicity after repeated s.c. doses of MOR106 administered concomitantly with TCS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864627
|United States, California|
|First OC Dermatology|
|Fountain Valley, California, United States, 92708|
|Marvel Research, LLC|
|Huntington Beach, California, United States, 92647|
|LA Universal Research Center, Inc.|
|Los Angeles, California, United States, 90057|
|San Diego, California, United States, 92103|
|United States, Florida|
|Encore Medical Research|
|Hollywood, Florida, United States, 33021|
|Advanced Research Institute of Miami LLC|
|Homestead, Florida, United States, 33030|
|Vista Health Research|
|Miami, Florida, United States, 33185|
|United States, Illinois|
|Rolling Meadows, Illinois, United States, 60008|
|United States, Indiana|
|Dawes Fretzin Clinical Research Group, LLC|
|Indianapolis, Indiana, United States, 46250|
|United States, Kentucky|
|Louisville, Kentucky, United States, 40241|
|United States, New York|
|Greenwich Village Dermatology|
|New York, New York, United States, 10012|
|United States, Texas|
|Center for Clinical Studies|
|Houston, Texas, United States, 77004|
|Progressive Clinical Research|
|San Antonio, Texas, United States, 78229|
|Center for Clinical Studies|
|Webster, Texas, United States, 77598|
|Study Director:||Helen Timmis, MB CHB||Galapagos NV|