First in Human of Single and Multiple Doses of MOR106

NCT02739009 | Completed Phase 1

• 1 other identifier: MOR106-CL-101
• Study Type: interventional
• Target: 81
• Locations: 4 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Serum concentration (Cinf) of MOR106

  up to 99 days after dosing

• Area under the curve (AUC) of MOR106

  up to 99 days after dosing

• terminal elimination half-life (t1/2) of MOR106

  up to 99 days after dosing

• total serum clearance (CL) of MOR106

  up to 99 days after dosing

• volume of distribution at steady state (Vss) of MOR106

  up to 99 days after dosing

Study Arms (4)

MOR106

EXPERIMENTAL

Single intravenous administration of MOR106

Drug: MOR106 single ascending doses, intravenous

Placebo

PLACEBO COMPARATOR

Single intravenous administration of Placebo

Drug: Placebo single ascending doses, intravenous

MOR106 MAD

EXPERIMENTAL

Multiple intravenous administration of MOR106

Drug: MOR106 multiple ascending doses, intravenous

Placebo MAD

PLACEBO COMPARATOR

Multiple intravenous adminstration of Placebo

Drug: Placebo multiple intravenous administrations

Interventions

MOR106 single ascending doses, intravenous DRUG

MOR106

Placebo single ascending doses, intravenous DRUG

Placebo

MOR106 multiple ascending doses, intravenous DRUG

MOR106 MAD

Placebo multiple intravenous administrations DRUG

Placebo MAD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Galapagos NV: lead
• MorphoSys AG: collaborator

Study Sites (4)

SGS LSS Clinical Pharmacology Unit

Antwerp, Belgium

Location

St Johns Hospital

Budapest, Hungary

Location

• Arensia Phase I unit

Chisinau, Moldova

Location

Arensia Phase I unit

Bucharest, Romania

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Helen Timmis, MBChB

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 14, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Locations

MO (1); HU (1); BE (1); RO (1)