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

Phase 1

Completed

• Conditions: Healthy Subjects and Atopic Dermatitis Subjects
• Interventions: Biological: BMS-981164; Biological: Placebo matching with BMS-981164

• Registration Number: NCT01614756
• Lead Sponsor: Bristol-Myers Squibb

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

Study Timeline

• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-08
• Study Start: 2012-07
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo	BMS-981164	Part 1 Single dose of BMS-981164 0.1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo	BMS-981164	Part 1 Single dose of BMS-981164 0.03 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo	BMS-981164	Part 1 Single dose of BMS-981164 0.01 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo	Placebo matching with BMS-981164	Part 1 Single dose of BMS-981164 0.01 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo	Placebo matching with BMS-981164	Part 1 Single dose of BMS-981164 0.06 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo	Placebo matching with BMS-981164	Part 1 Single dose of BMS-981164 0.1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo	BMS-981164	Part 1 Single dose of BMS-981164 1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo	BMS-981164	Part 1 Single dose of BMS-981164 1 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously
Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo	BMS-981164	Part 1 Single dose of BMS-981164 3 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously
Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo	Placebo matching with BMS-981164	Part 1 Single dose of BMS-981164 0.03 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo	BMS-981164	Part 1 Single dose of BMS-981164 0.06 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo	BMS-981164	Part 1 Single dose of BMS-981164 0.3 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo	Placebo matching with BMS-981164	Part 1 Single dose of BMS-981164 0.1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo	BMS-981164	Part 1 Single dose of BMS-981164 0.1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo	Placebo matching with BMS-981164	Part 1 Single dose of BMS-981164 1 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously
Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo	BMS-981164	Part 1 Single dose of BMS-981164 10.0 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously
Dose Escalation- BMS-981164 or Placebo (dose group 2)	BMS-981164	Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0.1 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose
Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo	Placebo matching with BMS-981164	Part 1 Single dose of BMS-981164 0.3 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo	Placebo matching with BMS-981164	Part 1 Single dose of BMS-981164 1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation- BMS-981164 or Placebo (dose group 1)	BMS-981164	Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 3 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 0 mg, once, single dose
Dose Escalation- BMS-981164 or Placebo (dose group 4)	Placebo matching with BMS-981164	Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 3.0 mg/kg and \>1.0mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose
Dose Escalation- BMS-981164 or Placebo (dose group 2)	Placebo matching with BMS-981164	Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0.1 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose
Dose Escalation- BMS-981164 or Placebo (dose group 3)	Placebo matching with BMS-981164	Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 0.1 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose
Dose Escalation- BMS-981164 or Placebo (dose group 4)	BMS-981164	Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 3.0 mg/kg and \>1.0mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose
Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo	Placebo matching with BMS-981164	Part 1 Single dose of BMS-981164 3 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously
Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo	Placebo matching with BMS-981164	Part 1 Single dose of BMS-981164 10.0 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously
Dose Escalation- BMS-981164 or Placebo (dose group 1)	Placebo matching with BMS-981164	Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 3 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 0 mg, once, single dose
Dose Escalation- BMS-981164 or Placebo (dose group 3)	BMS-981164	Part 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 0.1 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose

Primary Outcome Measures

Name	Time	Method
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	Up to 16 weeks after single dose

Secondary Outcome Measures

Name	Time	Method
The Maximum observed serum concentration (Cmax) of BMS-981164 will be derived from serum concentration versus time	13 timepoints upto 16 weeks after single dose
The Time of maximum observed serum concentration (Tmax) of BMS-981164 will be derived from serum concentration versus time	13 timepoints upto 16 weeks after single dose
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	13 timepoints upto 16 weeks after single dose
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	13 timepoints upto 16 weeks after single dose
The Terminal serum half-life (T-HALF) of BMS-981164 will be derived from serum concentration versus time	13 timepoints upto 16 weeks after single dose
The Apparent volume of distribution at steady state (Vss/F) of BMS-981164 will be derived from serum concentration versus time	13 timepoints upto 16 weeks after single dose
The Volume of distribution at steady state (Vss) of BMS-981164 will be derived from serum concentration versus time	13 timepoints upto 16 weeks after single dose
The Apparent total body clearance (CLT/F) of BMS-981164 will be derived from serum concentration versus time	13 timepoints upto 16 weeks after single dose
The Total body clearance (CLT) of BMS-981164 will be derived from serum concentration versus time	13 timepoints upto 16 weeks after single dose
The Absolute bioavailability (F) of BMS-981164 will be derived from serum concentration versus time	13 timepoints upto 16 weeks after single dose
Frequency of subjects with one or more positive post-treatment anti-drug antibodies (ADA) assessments	Up to 16 weeks after single dose	The Immunogenicity of BMS-981164 will be assessed by this ADA assessments

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Nottingham, United Kingdom