First in Human of Single and Multiple Doses of MOR106

NCT ID: NCT02739009

Last Updated: 2017-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-08-01

Brief Summary

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.

Conditions

Healthy; Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MOR106

Single intravenous administration of MOR106

Group Type: EXPERIMENTAL

MOR106 single ascending doses, intravenous

Intervention Type: DRUG

Placebo

Single intravenous administration of Placebo

Group Type: PLACEBO_COMPARATOR

Placebo single ascending doses, intravenous

Intervention Type: DRUG

MOR106 MAD

Multiple intravenous administration of MOR106

Group Type: EXPERIMENTAL

MOR106 multiple ascending doses, intravenous

Intervention Type: DRUG

Placebo MAD

Multiple intravenous adminstration of Placebo

Group Type: PLACEBO_COMPARATOR

Placebo multiple intravenous administrations

Intervention Type: DRUG

Interventions

MOR106 single ascending doses, intravenous

Intervention Type: DRUG

Placebo single ascending doses, intravenous

Intervention Type: DRUG

MOR106 multiple ascending doses, intravenous

Intervention Type: DRUG

Placebo multiple intravenous administrations

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MorphoSys AG

INDUSTRY

Sponsor Role: collaborator

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helen Timmis, MBChB

Role: STUDY_DIRECTOR

Galapagos NV

Locations

SGS LSS Clinical Pharmacology Unit

Antwerp, , Belgium

St Johns Hospital

Budapest, , Hungary

• Arensia Phase I unit

Chisinau, , Moldova

Arensia Phase I unit

Bucharest, , Romania

Countries

Belgium; Hungary; Moldova; Romania

Other Identifiers

MOR106-CL-101

Identifier Type: -

Identifier Source: org_study_id