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

This study is currently recruiting participants.
Verified May 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01614756
First received: June 6, 2012
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Healthy Subjects and Atopic Dermatitis Subjects
Biological: BMS-981164
Biological: Placebo matching with BMS-981164
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency of subjects with one or more positive post-treatment anti-drug antibodies (ADA) assessments [ Time Frame: Up to 16 weeks after single dose ] [ Designated as safety issue: No ]
    The Immunogenicity of BMS-981164 will be assessed by this ADA assessments


Estimated Enrollment: 88
Study Start Date: July 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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, 1 level below the highest dose tested and found to be safe in Part 1, 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 Name: 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 or IV, 1 level below the highest dose tested and found to be safe in Part 1, 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 Name: 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 or IV, 1 level below the highest dose tested and found to be safe in Part 1, 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 Name: 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 or IV, 1 level below the highest dose tested and found to be safe in Part 1, 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 Name: IL-31 mAB
Biological: Placebo matching with BMS-981164

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614756

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
United Kingdom
Local Institution Recruiting
Manchester, Greater Manchester, United Kingdom, M6 8HD
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01614756     History of Changes
Other Study ID Numbers: IM134-002, 2012-001865-34
Study First Received: June 6, 2012
Last Updated: May 31, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014