A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)

NCT02553330 | Terminated Phase 2 Results

• 1 other identifier: INCB 18424-204
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 18

Brief Summary

A phase 2 study to find out if the drug ruxolitinib Phosphate Cream is safe and has beneficial effects in people who have alopecia areata (partial or complete hair loss) when applied to the skin.

Conditions

Alopecia Areata

Keywords

Hair loss; alopecia areata; alopecia totalis; alopecia universalis; JAK inhibitors; topical hair growth

Outcome Measures

Primary Outcomes (2)

• Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).

  Percentage of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.

  Up to Week 24

• Part B : Percentage of Participants Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented)

  Percentage of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.

  Week 24

Secondary Outcomes (7)

• Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.

  Up to Week 24

• Part B : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).

  Week 24

• Part A and B : Percentage of Participants Achieving a SALT90 Response in Terminal Hair.

  Weeks 4, 8, 12, 18, and 24.

• Part B : Percentage of Subjects Whose AA Lesions Treated Since Baseline Achieved a Physician's Global Assessment of Regrowth (PGARG) Score of at Least 3

  Baseline to Week 24

• Part B : Percentage of Participants Achieving a SALT50 in Terminal Hair (Pigmented and Nonpigmented).

  Weeks 4, 8, 12, and 18.

Study Arms (2)

Ruxolitinib Phosphate Cream

EXPERIMENTAL

Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks; Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.

Drug: Ruxolitinib Phosphate Cream

Placebo Cream

PLACEBO COMPARATOR

Part B: Double-blind treatment is 24 weeks (and/or treatment with Ruxolitinib Phosphate Cream if eligible) and follow-up is an additional 12 weeks.

Drug: Placebo Cream; Drug: Ruxolitinib Phosphate Cream

Interventions

Placebo Cream DRUG

Placebo Cream

Ruxolitinib Phosphate Cream DRUG

Also known as: INCB018424

Placebo Cream; Ruxolitinib Phosphate Cream

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of AA
• Duration and extent of current episode of AA
• Evidence of active hair loss

You may not qualify if:

• Evidence of diffuse, spontaneous terminal hair regrowth
• Receipt of treatment known to potentially affect the course of AA within last month

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (18)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Hot Springs, Arkansas, United States

Location

Unknown Facility

New Haven, Connecticut, United States

Location

Unknown Facility

Trumbull, Connecticut, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Beverly, Massachusetts, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Clinton Township, Michigan, United States

Location

Unknown Facility

Fort Gratiot, Michigan, United States

Location

Unknown Facility

Fridley, Minnesota, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Katy, Texas, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

Related Publications (1)

• Bayart CB, DeNiro KL, Brichta L, Craiglow BG, Sidbury R. Topical Janus kinase inhibitors for the treatment of pediatric alopecia areata. J Am Acad Dermatol. 2017 Jul;77(1):167-170. doi: 10.1016/j.jaad.2017.03.024. No abstract available.

  PMID: 28619556 DERIVED

MeSH Terms

Conditions

Alopecia Areata; Alopecia; Alopecia universalis

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Incyte Organization

medinfo@incyte.com

855-463-3463

Study Officials

• Kathleen Butler, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 17, 2015
• Study Start: November 18, 2015
• Primary Completion: October 3, 2017
• Study Completion: October 3, 2017
• Last Updated: December 16, 2020
• Results First Posted: December 16, 2020

Record last verified: 2020-11

Locations

US (18)