A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib 0.15% Cream QD — DRUG
  Ruxolitinib 0.15% cream QD
• Ruxolitinib 0.5% Cream QD — DRUG
  Ruxolitinib 0.5% cream QD
• Ruxolitinib 1.5% Cream QD — DRUG
  Ruxolitinib 1.5% cream QD
• Ruxolitinib 1.5% Cream BID — DRUG
  Ruxolitinib 1.5% cream BID
• Triamcinolone 0.1% Cream BID — DRUG
  Triamcinolone 0.1% cream BID
• Vehicle Cream BID — DRUG
  Vehicle cream BID

Study Details

The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.

Key Dates

Start date

Jan 9, 2017

Status verified

Mar 2021

Primary completion

Jan 10, 2018

Completion

Mar 12, 2018

Study Design

Enrollment

307 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Double Blind (DB): Vehicle BID
  Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.
• Active Comparator: DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID
  Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.
• Experimental: DB: Ruxolitinib 0.15% Once Daily (QD)
  Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.
• Experimental: DB: Ruxolitinib 0.5% QD
  Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.
• Experimental: DB: Ruxolitinib 1.5% QD
  Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.
• Experimental: DB: Ruxolitinib 1.5% BID
  Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.
• Placebo Comparator: Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID
  Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
• Active Comparator: OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID
  Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
• Experimental: OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID
  Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
• Experimental: OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID
  Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
• Experimental: OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID
  Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.
• Experimental: OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID
  Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.

Primary Outcome Measure

Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID [ Time Frame: Baseline and Week 4 ]

Locations (35)

Find similar trials in Birmingham, AL

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