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

NCT ID: NCT02553330

Last Updated: 2020-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-18

Study Completion Date

2017-10-03

Brief Summary

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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.

Detailed Description

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Conditions

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Alopecia Areata

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ruxolitinib Phosphate Cream

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.

Group Type EXPERIMENTAL

Ruxolitinib Phosphate Cream

Intervention Type DRUG

Placebo Cream

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.

Group Type PLACEBO_COMPARATOR

Placebo Cream

Intervention Type DRUG

Ruxolitinib Phosphate Cream

Intervention Type DRUG

Interventions

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Placebo Cream

Intervention Type DRUG

Ruxolitinib Phosphate Cream

Intervention Type DRUG

Other Intervention Names

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INCB018424

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Incyte Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Butler, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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Birmingham, Alabama, United States

Site Status

Hot Springs, Arkansas, United States

Site Status

New Haven, Connecticut, United States

Site Status

Trumbull, Connecticut, United States

Site Status

Miami, Florida, United States

Site Status

Beverly, Massachusetts, United States

Site Status

Boston, Massachusetts, United States

Site Status

Clinton Township, Michigan, United States

Site Status

Fort Gratiot, Michigan, United States

Site Status

Fridley, Minnesota, United States

Site Status

Minneapolis, Minnesota, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Cleveland, Ohio, United States

Site Status

Portland, Oregon, United States

Site Status

Austin, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Katy, Texas, United States

Site Status

Norfolk, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28619556 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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INCB 18424-204

Identifier Type: -

Identifier Source: org_study_id