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Completed

NCT Number: NCT01614756

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

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

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Key information

Conditions

Healthy Subjects and Atopic Dermatitis Subjects

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Manchester, Greater Manchester, United Kingdom

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-981164

Biological

Other names: IL-31 mAB

Placebo matching with BMS-981164

Biological

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 8, 2012
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.