search
Back to results

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

Primary Purpose

Healthy Subjects and Atopic Dermatitis Subjects

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
BMS-981164
Placebo matching with BMS-981164
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Subjects and Atopic Dermatitis Subjects

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo

Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo

Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo

Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo

Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo

Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo

Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo

Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo

Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo

Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo

Dose Escalation- BMS-981164 or Placebo (dose group 1)

Dose Escalation- BMS-981164 or Placebo (dose group 2)

Dose Escalation- BMS-981164 or Placebo (dose group 3)

Dose Escalation- BMS-981164 or Placebo (dose group 4)

Arm Description

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
June 6, 2012
Last Updated
August 18, 2015
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT01614756
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects and Atopic Dermatitis Subjects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation- BMS-981164 or Placebo (dose group 1)
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation- BMS-981164 or Placebo (dose group 2)
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation- BMS-981164 or Placebo (dose group 3)
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Escalation- BMS-981164 or Placebo (dose group 4)
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
BMS-981164
Other Intervention Name(s)
IL-31 mAB
Intervention Type
Biological
Intervention Name(s)
Placebo matching with BMS-981164
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Frequency of subjects with one or more positive post-treatment anti-drug antibodies (ADA) assessments
Description
The Immunogenicity of BMS-981164 will be assessed by this ADA assessments
Time Frame
Up to 16 weeks after single dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M15 6SH
Country
United Kingdom
Facility Name
Local Institution
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Local Institution
City
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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

We'll reach out to this number within 24 hrs