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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

NCT ID: NCT01614756

Last Updated: 2015-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-04-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Healthy Subjects and Atopic Dermatitis Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

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

Group Type EXPERIMENTAL

BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

Interventions

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BMS-981164

Intervention Type BIOLOGICAL

Placebo matching with BMS-981164

Intervention Type BIOLOGICAL

Other Intervention Names

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IL-31 mAB

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Manchester, Greater Manchester, United Kingdom

Site Status

Local Institution

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Local Institution

Manchester, , United Kingdom

Site Status

Local Institution

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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2012-001865-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM134-002

Identifier Type: -

Identifier Source: org_study_id

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