Clinical trial NCT01614756: A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody); in Healthy Subjects and Adults With Atopic Dermatitis
Official title: A Two-Part, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study of Subcutaneous and Intravenous Administration of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody; BMS-981164) in Healthy Subjects and Adult Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects and Atopic Dermatitis Subjects
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 93
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: The purpose of the study is to determine safety and tolerability of IL-31 mAB

Detailed description: Healthy Volunteers not acceptable for "Part 2" (Adult subjects with Atopic Dermatitis)

Enrollment: (both Part 1 and Part 2) Part 2 will consist of up to 42 patients with atopic dermatitis

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Part 1: Healthy subjects
* Part 2: Adult subjects with:

  1. Atopic dermatitis severity as assessed by Physician Global Assessment rating of 3 or higher (i.e., moderate or greater) on a scale of 0 to 5
  2. Pruritus severity of at least 7 of 10 on a visual analog scale

Exclusion Criteria:

* Receipt of systemic immunosuppressants, other than biological agents, or topical calcineurin inhibitors (tacrolimus or pimecrolimus) within 4 weeks prior to study drug administration

Primary outcomes:
measure: For both Part 1 and Part 2, the primary endpoint will be based on incident adverse event reports, vital sign measurements, physical (including injection site) examinations, electrocardiograms (ECGs), medical history, and clinical laboratory tests
timeFrame: Up to 16 weeks after single dose
Secondary outcomes:
measure: The Maximum observed serum concentration (Cmax) of BMS-981164 will be derived from serum concentration versus time
timeFrame: 13 timepoints upto 16 weeks after single dose
measure: The Time of maximum observed serum concentration (Tmax) of BMS-981164 will be derived from serum concentration versus time
timeFrame: 13 timepoints upto 16 weeks after single dose
measure: The Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-981164 will be derived from serum concentration versus time
timeFrame: 13 timepoints upto 16 weeks after single dose
measure: The Area under the serum concentration-time curve from zero to time of the last quantifiable concentration [AUC(0-T)] of BMS-981164 will be derived from serum concentration versus time
timeFrame: 13 timepoints upto 16 weeks after single dose
measure: The Terminal serum half-life (T-HALF) of BMS-981164 will be derived from serum concentration versus time
timeFrame: 13 timepoints upto 16 weeks after single dose
measure: The Apparent volume of distribution at steady state (Vss/F) of BMS-981164 will be derived from serum concentration versus time
timeFrame: 13 timepoints upto 16 weeks after single dose
measure: The Volume of distribution at steady state (Vss) of BMS-981164 will be derived from serum concentration versus time
timeFrame: 13 timepoints upto 16 weeks after single dose
measure: The Apparent total body clearance (CLT/F) of BMS-981164 will be derived from serum concentration versus time
timeFrame: 13 timepoints upto 16 weeks after single dose
measure: The Total body clearance (CLT) of BMS-981164 will be derived from serum concentration versus time
timeFrame: 13 timepoints upto 16 weeks after single dose
measure: The Absolute bioavailability (F) of BMS-981164 will be derived from serum concentration versus time
timeFrame: 13 timepoints upto 16 weeks after single dose
measure: Frequency of subjects with one or more positive post-treatment anti-drug antibodies (ADA) assessments
timeFrame: Up to 16 weeks after single dose
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution
state: Tyne And Wear
city: Manchester
country: United Kingdom
facility: Local Institution
city: Nottingham
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: