Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Participants With Moderate to Severe Atopic Dermatitis (NCT NCT03864627)

Last Updated: 2021-01-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

Day 1 up to Day 169/Early discontinuation(ED)

Results posted on

2021-01-05

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	Placebo 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.	MOR106 320 mg 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.
Overall Study STARTED	11	22
Overall Study COMPLETED	7	10
Overall Study NOT COMPLETED	4	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 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.	MOR106 320 mg 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.
Overall Study Adverse Event	0	1
Overall Study Lack of Efficacy	0	1
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	4	8
Overall Study Study terminated by sponsor	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=11 Participants 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.	MOR106 320 mg n=22 Participants 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 n=33 Participants Total of all reporting groups
Age, Continuous	39.8 years STANDARD_DEVIATION 17.85 • n=5 Participants	36.1 years STANDARD_DEVIATION 13.34 • n=7 Participants	37.4 years STANDARD_DEVIATION 14.82 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 up to Day 169/Early discontinuation(ED)

Population: The safety analysis set included all participants who received at least one dose of IMP.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants 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.	MOR106 320 mg n=22 Participants 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs) AESI: ISRs	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs) TEAE	5 Participants	11 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs) AESI: SRE	2 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious Adverse Events (SAEs) SAE	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants 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.	MOR106 320 mg 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.
Serum Concentrations of MOR106 Day 1	0.149 microgram per milliliter (µg/mL) Standard Deviation 0.2505	—
Serum Concentrations of MOR106 Day 4	61.150 microgram per milliliter (µg/mL) Standard Deviation 28.3850	—
Serum Concentrations of MOR106 Day 15	41.278 microgram per milliliter (µg/mL) Standard Deviation 21.4046	—
Serum Concentrations of MOR106 Day 29	39.473 microgram per milliliter (µg/mL) Standard Deviation 15.8087	—
Serum Concentrations of MOR106 Day 43	42.537 microgram per milliliter (µg/mL) Standard Deviation 23.8095	—
Serum Concentrations of MOR106 Day 57	40.934 microgram per milliliter (µg/mL) Standard Deviation 17.6737	—
Serum Concentrations of MOR106 Day 71	16.593 microgram per milliliter (µg/mL) Standard Deviation 7.3308	—
Serum Concentrations of MOR106 Day 85	9.775 microgram per milliliter (µg/mL) Standard Deviation 3.2489	—
Serum Concentrations of MOR106 Day 99	5.092 microgram per milliliter (µg/mL) Standard Deviation 1.0801	—
Serum Concentrations of MOR106 Day 113	2.415 microgram per milliliter (µg/mL) Standard Deviation 1.3466	—
Serum Concentrations of MOR106 Day 127	1.407 microgram per milliliter (µg/mL) Standard Deviation 0.8124	—
Serum Concentrations of MOR106 Day 141	1.812 microgram per milliliter (µg/mL) Standard Deviation 2.4765	—
Serum Concentrations of MOR106 Day 155	1.043 microgram per milliliter (µg/mL) Standard Deviation 1.2149	—
Serum Concentrations of MOR106 Day 169	0.690 microgram per milliliter (µg/mL) Standard Deviation 0.9707	—

SECONDARY outcome

Timeframe: Day 1 up to Day 169/ED

Population: Safety analysis set.

Outcome measures

Outcome measures
Measure	Placebo n=11 Participants 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.	MOR106 320 mg n=22 Participants 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.
Number of Participants With Anti-drug Antibodies (ADAs)	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

MOR106 320 mg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=11 participants at risk 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.	MOR106 320 mg n=22 participants at risk 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.
Gastrointestinal disorders Gastric ulcer	0.00% 0/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.
General disorders Pyrexia	0.00% 0/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.
Infections and infestations Pneumonia	0.00% 0/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.

Other adverse events

Additional Information

Galapagos Medical Information

Galapagos NV

Phone: +32 15 342900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=11 participants at risk 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.	MOR106 320 mg n=22 participants at risk 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.
General disorders Injection site reaction	9.1% 1/11 • Day 1 up to Day 169/ED Safety analysis set.	9.1% 2/22 • Day 1 up to Day 169/ED Safety analysis set.
Infections and infestations Folliculitis	9.1% 1/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.
Infections and infestations Nasopharyngitis	9.1% 1/11 • Day 1 up to Day 169/ED Safety analysis set.	0.00% 0/22 • Day 1 up to Day 169/ED Safety analysis set.
Infections and infestations Upper respiratory tract infection	9.1% 1/11 • Day 1 up to Day 169/ED Safety analysis set.	0.00% 0/22 • Day 1 up to Day 169/ED Safety analysis set.
Metabolism and nutrition disorders Hyperuricaemia	9.1% 1/11 • Day 1 up to Day 169/ED Safety analysis set.	0.00% 0/22 • Day 1 up to Day 169/ED Safety analysis set.
Skin and subcutaneous tissue disorders Skin exfoliation	9.1% 1/11 • Day 1 up to Day 169/ED Safety analysis set.	0.00% 0/22 • Day 1 up to Day 169/ED Safety analysis set.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	9.1% 1/11 • Day 1 up to Day 169/ED Safety analysis set.	0.00% 0/22 • Day 1 up to Day 169/ED Safety analysis set.
Nervous system disorders Burning sensation	0.00% 0/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.
Nervous system disorders Headache	0.00% 0/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.
Nervous system disorders Presyncope	0.00% 0/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.
Cardiac disorders Atrioventricular block first degree	0.00% 0/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.
Cardiac disorders Tachycardia	0.00% 0/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/11 • Day 1 up to Day 169/ED Safety analysis set.	4.5% 1/22 • Day 1 up to Day 169/ED Safety analysis set.