TRuE AD2 - An Efficacy and Safety Study of Ruxolitinib Cream in Adolescents and Adults With Atopic Dermatitis

Conditions

• Atopic Dermatitis

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib cream — DRUG
  Ruxolitinib 0.75% or 1.5% cream.
• Vehicle cream — DRUG
  Ruxolitinib matching vehicle cream.

Study Details

The purpose of this study is to assess the efficacy of ruxolitinib cream in adolescents and adults with atopic dermatitis (AD).

Key Dates

Start date

Dec 20, 2018

Status verified

Sep 2023

Primary completion

Nov 18, 2019

Completion

Nov 9, 2020

Study Design

Enrollment

618 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Vehicle Control (VC) Period: Vehicle Cream BID
  Participants received ruxolitinib matching vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
• Experimental: VC Period: Ruxolitinib 0.75% Cream BID
  Participants received ruxolitinib 0.75% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
• Experimental: VC Period: Ruxolitinib 1.5% Cream BID
  Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film BID 8 hours apart from Day 1 up to Week 8. Participants applied cream BID to areas identified at Baseline even if the areas improved.
• Experimental: Long-Term Safety (LTS) Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID
  Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
• Experimental: LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID
  Participants who applied vehicle cream during the VC Period were randomized at Week 8 to apply ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
• Experimental: LTS Period: Ruxolitinib 0.75% Cream BID
  Participants who applied ruxolitinib 0.75% cream during the VC Period, continued applying ruxolitinib 0.75% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
• Experimental: LTS Period: Ruxolitinib 1.5% Cream BID
  Participants who applied ruxolitinib 1.5% cream during the VC Period, continued applying ruxolitinib 1.5% cream, topically to the affected areas as a thin film BID as needed from Week 8 up to Week 52. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.

Primary Outcome Measure

VC Period: Percentage of Participants Who Achieved Investigator's Global Assessment - Treatment Success (IGA-TS) at Week 8 [ Time Frame: Baseline to Week 8 ]

Locations (35)

Find similar trials in Birmingham, AL

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