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

August 18, 2015 updated by: Bristol-Myers Squibb

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

The purpose of the study is to determine safety and tolerability of IL-31 mAB

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M6 8HD
        • Local Institution
      • Nottingham, United Kingdom, NG11 6JS
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M15 6SH
        • Local Institution
    • Tyne And Wear
      • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation- BMS-981164 or Placebo (dose group 1)

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation- BMS-981164 or Placebo (dose group 2)

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation- BMS-981164 or Placebo (dose group 3)

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164
Experimental: Dose Escalation- BMS-981164 or Placebo (dose group 4)

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
Biological: BMS-981164
Other Names:
  • IL-31 mAB
Biological: Placebo matching with BMS-981164

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Up to 16 weeks after single dose
Up to 16 weeks after single dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Maximum observed serum concentration (Cmax) of BMS-981164 will be derived from serum concentration versus time
Time Frame: 13 timepoints upto 16 weeks after single dose
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
Time Frame: 13 timepoints upto 16 weeks after single dose
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
Time Frame: 13 timepoints upto 16 weeks after single dose
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
Time Frame: 13 timepoints upto 16 weeks after single dose
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
Time Frame: 13 timepoints upto 16 weeks after single dose
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
Time Frame: 13 timepoints upto 16 weeks after single dose
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
Time Frame: 13 timepoints upto 16 weeks after single dose
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
Time Frame: 13 timepoints upto 16 weeks after single dose
13 timepoints upto 16 weeks after single dose
The Total body clearance (CLT) of BMS-981164 will be derived from serum concentration versus time
Time Frame: 13 timepoints upto 16 weeks after single dose
13 timepoints upto 16 weeks after single dose
The Absolute bioavailability (F) of BMS-981164 will be derived from serum concentration versus time
Time Frame: 13 timepoints upto 16 weeks after single dose
13 timepoints upto 16 weeks after single dose
Frequency of subjects with one or more positive post-treatment anti-drug antibodies (ADA) assessments
Time Frame: Up to 16 weeks after single dose
The Immunogenicity of BMS-981164 will be assessed by this ADA assessments
Up to 16 weeks after single dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (Estimate)

June 8, 2012

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM134-002
  • 2012-001865-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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