Clinical trial NCT02739009: First in Human of Single and Multiple Doses of MOR106
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Dermatitis, Atopic
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
Collaborators: name: MorphoSys AG
First posted: 2016-04-14
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Difference as compared to placebo in the number of subjects with treatment-emergent adverse events
timeFrame: Up to 99 days after dosing
measure: Difference as compared to placebo in the number of subjects with deviating physical examination results
timeFrame: Up to 99 days after dosing
measure: Difference as compared to placebo in the number of subjects with abnormal vital signs
timeFrame: Up to 99 days after dosing
measure: Difference as compared to placebo in the number of subjects with abnormal 12-lead ECG results
timeFrame: Up to 99 days after dosing
measure: Difference as compared to placebo in the number of subjects with abnormal laboratory findings
timeFrame: Up to 99 days after dosing
measure: Difference as compared to placebo in the occurrence of infusion related reactions
timeFrame: Up to 99 days after dosing
Secondary outcomes:
measure: Serum concentration (Cinf) of MOR106
timeFrame: up to 99 days after dosing
measure: Area under the curve (AUC) of MOR106
timeFrame: up to 99 days after dosing
measure: terminal elimination half-life (t1/2) of MOR106
timeFrame: up to 99 days after dosing
measure: total serum clearance (CL) of MOR106
timeFrame: up to 99 days after dosing
measure: volume of distribution at steady state (Vss) of MOR106
timeFrame: up to 99 days after dosing
measure: The presence of anti-drug antibodies in serum over time after single intravenous dose
timeFrame: up to 9 days after dosing
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit
city: Budapest
country: Hungary
facility: St Johns Hospital
city: Chisinau
country: Moldova, Republic of
facility: • Arensia Phase I unit
city: Bucharest
country: Romania
facility: Arensia Phase I unit
Study officials:
affiliation: Galapagos NV
name: Helen Timmis, MBChB
role: STUDY_DIRECTOR
References: