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

• Sponsor: Galapagos NV (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03864627
• Collaborator: (none)
• Enrollment: 33
• Locations: 14
• Arms: 2
• Actual Duration (Months): 11.1
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To investigate the safety and tolerability of repeated subcutaneous (s.c.) doses of MOR106 administered concomitantly with topical corticosteroids (TCS) in participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: MOR106; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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: Mar 25, 2019
• Actual Primary Completion Date: Feb 27, 2020
• Actual Study Completion Date: Feb 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants will receive MOR106 matching placebo via s.c. injection every other week on Day 1, 15, 29 and 43 given concomitantly with a medium potency TCS once daily until Day 57.	Drug: Placebo; Placebo liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).
Experimental: MOR106 320 mg Participants will receive MOR106 320 milligrams (mg) via s.c. injection every other week on Day 15, 29 and 43 given concomitantly with a medium potency topical TCS once daily until Day 57. A loading dose of MOR106 2 x 320 mg via s.c. injection will be administered on Day 1.	Drug: MOR106; MOR106 liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs) [Day 1 up to Day 169/Early discontinuation(ED)]

   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.

Secondary Outcome Measures

1. Serum Concentrations of MOR106 [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]

2. Number of Participants With Anti-drug Antibodies (ADAs) [Day 1 up to Day 169/ED]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• A BMI 18 - 40 kilogram per meter square (kg/m^2), inclusive.

• Diagnosis of atopic dermatitis for at least one year since first diagnosis as per the Hanifin and Rajka Criteria.

• Eczema Area and Severity Index (EASI) ≥ 16 at the screening and at the baseline visit (Day 1 predose).

• Investigators' Global Assessment (IGA) score ≥ 3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and baseline visits.

• Greater than or equal to 10% body surface area (BSA) of AD involvement at the screening and baseline visits.

• Willingness to use a non-medicated, simple bland emollient twice daily for at least 7 days before the baseline visit and throughout the study.

Exclusion Criteria:

• Prior treatment with MOR106.

• Known hypersensitivity to any investigational medicinal product (IMP) ingredients as determined by the investigator (such as, but not limited to, anaphylaxis requiring hospitalization).

• AD lesions located predominantly (≥ 50% of cumulative lesional area) on face and genital areas.

• Any concurrent illness, condition, disability, or clinically significant abnormality (including laboratory tests, a New York Heart Association Classification (NYHA) ≥ III/IV) or clinically significant illness in the 3 months prior to initial IMP administration that, in the investigator's opinion, represents a safety risk for the participant's participation in the study, may affect the interpretation of clinical safety or efficacy data, or may prevent the participant from safely completing the assessments required by the protocol.

• Clinically significant abnormalities at the discretion of the investigator detected on vital signs or physical examination (other than AD) at screening or baseline (Day 1 predose).

• History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection, as determined by a positive HIV test at screening).

• Active chronic or acute skin infection requiring treatment with systemic (oral, sc or

1. antibiotics, antivirals or antifungals within 4 weeks of baseline, or clinical signs of infective eczema within 7 days before baseline (Day 1 pre-dose).

• Having used any of the following treatments:

• Prior exposure to Dupilumab.

• Immunosuppressive/immunomodulating drugs (e.g. systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon (IFN)-γ, azathioprine, methotrexate) within 4 weeks of baseline (Day 1) visit.

• Phototherapy (ultraviolet B [UVB] or Psoralen Ultraviolet A [PUVA]) for AD within four weeks of baseline (Day 1) visit.

• Treatment with TCS or topical calcineurin inhibitor (TCI) within 7 days before the baseline (Day 1) visit.

• Treatment with biologics within five half-lives (if known) or 12 weeks prior to baseline visit, whichever is longer.

• Regular use (more than two visits per week) of a tanning booth/parlor within 4 weeks of the baseline visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First OC Dermatology	Fountain Valley	California	United States	92708
2	Marvel Research, LLC	Huntington Beach	California	United States	92647
3	LA Universal Research Center, Inc.	Los Angeles	California	United States	90057
4	MedDerm Associates	San Diego	California	United States	92103
5	Encore Medical Research	Hollywood	Florida	United States	33021
6	Advanced Research Institute of Miami LLC	Homestead	Florida	United States	33030
7	Vista Health Research	Miami	Florida	United States	33185
8	Arlington Dermatology	Rolling Meadows	Illinois	United States	60008
9	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana	United States	46250
10	DS Research	Louisville	Kentucky	United States	40241
11	Greenwich Village Dermatology	New York	New York	United States	10012
12	Center for Clinical Studies	Houston	Texas	United States	77004
13	Progressive Clinical Research	San Antonio	Texas	United States	78229
14	Center for Clinical Studies	Webster	Texas	United States	77598

Sponsors and Collaborators

• Galapagos NV

Investigators

• Study Director: Galapagos Medical Information, Galapagos NV

Study Documents (Full-Text)

• Study Protocol - Jun 25, 2019
• Statistical Analysis Plan - Mar 12, 2020

More Information

Publications

None provided.

• Responsible Party: Galapagos NV
• ClinicalTrials.gov Identifier: NCT03864627
• Other Study ID Numbers: MOR106-CL-204
• First Posted: Mar 6, 2019
• Last Update Posted: Jan 5, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

Participant Flow

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 Detail	A total of 76 participants were screened of which 33 participants were randomized into the study.

Arm/Group Title	Placebo	MOR106 320 mg
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

Baseline Characteristics

Arm/Group Title	Placebo	MOR106 320 mg	Total
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 Participants	11	22	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.8 (17.85)	36.1 (13.34)	37.4 (14.82)
Sex: Female, Male (Count of Participants)
Female	7 63.6%	11 50%	18 54.5%
Male	4 36.4%	11 50%	15 45.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 45.5%	11 50%	16 48.5%
Not Hispanic or Latino	6 54.5%	11 50%	17 51.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 9.1%	5 22.7%	6 18.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 9.1%	2 9.1%	3 9.1%
White	9 81.8%	15 68.2%	24 72.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs)
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)

Outcome Measure Data

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
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.
Measure Participants	11	22
TEAE	5 45.5%	11 50%
AESI: SRE	2 18.2%	1 4.5%
AESI: ISRs	0 0%	0 0%
SAE	0 0%	1 4.5%

2. Secondary Outcome

Title	Serum Concentrations of MOR106
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

Outcome Measure Data

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
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.
Measure Participants	20
Day 1	0.149 (0.2505)
Day 4	61.150 (28.3850)
Day 15	41.278 (21.4046)
Day 29	39.473 (15.8087)
Day 43	42.537 (23.8095)
Day 57	40.934 (17.6737)
Day 71	16.593 (7.3308)
Day 85	9.775 (3.2489)
Day 99	5.092 (1.0801)
Day 113	2.415 (1.3466)
Day 127	1.407 (0.8124)
Day 141	1.812 (2.4765)
Day 155	1.043 (1.2149)
Day 169	0.690 (0.9707)

3. Secondary Outcome

Title	Number of Participants With Anti-drug Antibodies (ADAs)
Time Frame	Day 1 up to Day 169/ED

Outcome Measure Data

Analysis Population Description

Safety analysis set.

Arm/Group Title	Placebo	MOR106 320 mg
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.
Measure Participants	11	22
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Day 1 up to Day 169/ED
Adverse Event Reporting Description	Safety analysis set.
Arm/Group Title	Placebo		MOR106 320 mg
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/22 (0%)
Serious Adverse Events
	Placebo		MOR106 320 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		1/22 (4.5%)
Gastrointestinal disorders
Gastric ulcer	0/11 (0%)		1/22 (4.5%)
General disorders
Pyrexia	0/11 (0%)		1/22 (4.5%)
Infections and infestations
Pneumonia	0/11 (0%)		1/22 (4.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease	0/11 (0%)		1/22 (4.5%)
Other (Not Including Serious) Adverse Events
	Placebo		MOR106 320 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/11 (45.5%)		11/22 (50%)
Cardiac disorders
Atrioventricular block first degree	0/11 (0%)		1/22 (4.5%)
Tachycardia	0/11 (0%)		1/22 (4.5%)
General disorders
Injection site reaction	1/11 (9.1%)		2/22 (9.1%)
Infections and infestations
Folliculitis	1/11 (9.1%)		1/22 (4.5%)
Nasopharyngitis	1/11 (9.1%)		0/22 (0%)
Upper respiratory tract infection	1/11 (9.1%)		0/22 (0%)
Injury, poisoning and procedural complications
Arthropod bite	0/11 (0%)		1/22 (4.5%)
Foot fracture	0/11 (0%)		1/22 (4.5%)
Metabolism and nutrition disorders
Hyperuricaemia	1/11 (9.1%)		0/22 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma	1/11 (9.1%)		0/22 (0%)
Nervous system disorders
Burning sensation	0/11 (0%)		1/22 (4.5%)
Headache	0/11 (0%)		1/22 (4.5%)
Presyncope	0/11 (0%)		1/22 (4.5%)
Skin and subcutaneous tissue disorders
Skin exfoliation	1/11 (9.1%)		0/22 (0%)
Miliaria	0/11 (0%)		1/22 (4.5%)

Limitations/Caveats

The study was terminated as MOR106, clinical development in atopic dermatitis was stopped for futility.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.