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. (see Contacts and Locations)
Verified September 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01614756
First received: June 6, 2012
Last updated: September 10, 2014
Last verified: September 2014
  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: June 2015
Estimated Primary Completion Date: June 2015 (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, 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 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, 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 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, ≤ 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 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, ≤ 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 Name: IL-31 mAB
Biological: Placebo matching with BMS-981164

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614756

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

Locations
United Kingdom
Local Institution Completed
Manchester, Greater Manchester, United Kingdom, M15 6SH
Local Institution Active, not recruiting
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE1 4LP
Local Institution Recruiting
Manchester, United Kingdom, M6 8HD
Contact: Site 0005         
Local Institution Completed
Nottingham, United Kingdom, NG11 6JS
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: September 10, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Dermatitis, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
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 September 16, 2014