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

Incyte

Status and phase: Terminated; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: Placebo Cream; Drug: Ruxolitinib Phosphate Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT02553330

INCB 18424-204

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Ruxolitinib Phosphate Cream

Experimental group

Description:

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.

Treatment:

Drug: Ruxolitinib Phosphate Cream

Placebo Cream

Placebo Comparator group

Description:

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.

Treatment:

Drug: Ruxolitinib Phosphate Cream

Drug: Placebo Cream