First in Human of Single and Multiple Doses of MOR106

This is a randomized, double-blind, placebo-controlled, dose-escalation, phase I study for the assessment of safety, tolerability and pharmacokinetics of single ascending doses of MOR106 in healthy male subjects and multiple ascending doses in subjects with moderate to severe atopic dermatitis.

Study Overview

• Status: Completed
• Conditions: Healthy; Dermatitis, Atopic
• Intervention / Treatment: Drug: MOR106 single ascending doses, intravenous; Drug: Placebo single ascending doses, intravenous; Drug: MOR106 multiple ascending doses, intravenous; Drug: Placebo multiple intravenous administrations

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • SGS LSS Clinical Pharmacology Unit
• Hungary
  • Budapest, Hungary
    • St Johns Hospital
• Moldova, Republic of
  • Chisinau, Moldova, Republic of
    • • Arensia Phase I unit
• Romania
  • Bucharest, Romania
    • Arensia Phase I unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Able and willing to give voluntary written informed consent

Single ascending dose (SAD)

• Negative urine drug screen
• Male between 18-50 years of age
• A body mass index (BMI) between 18-30 kg/m², inclusive.
• Judged to be in good health

Multiple ascending dose (MAD)

• Male or female between 18-65 years of age
• A BMI between 18-30 kg/m²
• Diagnosis of Atopic Dermatitis (AD) for at least 6 months as per the Hanifin and Rajka Criteria
• EASI ≥ 16 at the screening and baseline visits
• 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 screening
• Willingness to continue stable use of an additive free, basic, bland emollient twice daily for at least 7 days before the baseline visit
• Subject is a candidate for systemic therapy and is not responding adequately or has a contraindication to topical corticosteroids and/or topical calcineurin inhibitors (per Investigator's judgement)
• Absence of current active, latent or history of tuberculosis (TB) infection based on medical history and as determined by a negative QuantiFERON TB Gold test at screening
• Female subjects must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline
• Female subjects of childbearing potential must use a highly effective method contraception from 28 days prior to the first dose of study drug, during the study and for at least 24 weeks after the last dose

Exclusion Criteria:

• Known hypersensitivity to study drug ingredients.
• History of or a current immunosuppressive condition
• Symptoms of clinically significant illness in the 3 months before the initial study drug administration.
• Any concurrent illness, condition, disability, or clinically significant abnormality
• Treatment with any drug known to have a well-defined potential for toxicity to a major organ in the last 3 months preceding the initial study drug administration.
• A history of significant psychological, neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal (GI), pulmonary, or metabolic disease.

MAD only

• Active (skin) infection requiring systemic antibiotics
• immunosuppressive/immunomodulating drugs or phototherapy 4 weeks prior to baseline
• Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline
• Treatment with biologics within 5 half-lives (if known) or 12 weeks prior to baseline visit
• history of immunosuppression
• Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit
• Regular daily use of oral nonsteroidal anti-inflammatory drugs (NSAIDs), except low-dose aspirin (≤200 mg/day) for cardioprotection, within 7 days prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MOR106; Single intravenous administration of MOR106	Drug: MOR106 single ascending doses, intravenous
Placebo Comparator: Placebo; Single intravenous administration of Placebo	Drug: Placebo single ascending doses, intravenous
Experimental: MOR106 MAD; Multiple intravenous administration of MOR106	Drug: MOR106 multiple ascending doses, intravenous
Placebo Comparator: Placebo MAD; Multiple intravenous adminstration of Placebo	Drug: Placebo multiple intravenous administrations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference as compared to placebo in the number of subjects with treatment-emergent adverse events	To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo	Up to 99 days after dosing
Difference as compared to placebo in the number of subjects with deviating physical examination results	To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo	Up to 99 days after dosing
Difference as compared to placebo in the number of subjects with abnormal vital signs	To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo	Up to 99 days after dosing
Difference as compared to placebo in the number of subjects with abnormal 12-lead ECG results	To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo	Up to 99 days after dosing
Difference as compared to placebo in the number of subjects with abnormal laboratory findings	To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo	Up to 99 days after dosing
Difference as compared to placebo in the occurrence of infusion related reactions	To evaluate the safety and tolerability of single ascending doses of MOR106 intravenously given to healthy male subjects and of multiple ascending doses of MOR106 given intravenously to subjects with atopic dermatitis, compared to placebo	Up to 99 days after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration (Cinf) of MOR106	To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis	up to 99 days after dosing
Area under the curve (AUC) of MOR106	To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis	up to 99 days after dosing
terminal elimination half-life (t1/2) of MOR106	To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis	up to 99 days after dosing
total serum clearance (CL) of MOR106	To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis	up to 99 days after dosing
volume of distribution at steady state (Vss) of MOR106	To characterize the PK of MOR106 after single intravenous administration in healthy male volunteers and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis	up to 99 days after dosing
The presence of anti-drug antibodies in serum over time after single intravenous dose	To assess the presence of anti-drug antibodies as a measure of immunogenicity after single administration of MOR106 and after multiple ascending dose intravenous administration in subjects with severe atopic dermatitis	up to 9 days after dosing

Collaborators and Investigators

• Sponsor: Galapagos NV
• Collaborators: MorphoSys AG
• Investigators: Study Director: Helen Timmis, MBChB, Galapagos NV

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: MOR106-CL-101