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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects and Atopic Dermatitis Subjects

Treatments: Biological: Placebo matching with BMS-981164; Biological: BMS-981164

Study type: Interventional

Funder types: Industry

Identifiers

NCT01614756

2012-001865-34 (EudraCT Number)

IM134-002

Details and patient eligibility

About

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

Full 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

Enrollment: 93 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

93 participants in 14 patient groups

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164

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

Experimental group

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

Treatment:

Biological: BMS-981164

Biological: Placebo matching with BMS-981164