A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis

Pfizer

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Crisaborole 2%; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT04040192

CRISADE CONTROL (Other Identifier)

C3291035

2019-000443-28 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.

Full description

Approximately 700 participants will be enrolled in an run-in period to receive crisaborole, BID for up to a maximum of 8 weeks to identify crisaborole responders. A responder is defined as a participant who achieves both ISGA and EASI50 success. ISGA success is defined as achieving a score of 0 or 1 with at least 2 grade improvement from baseline; and the EASI50 success is defined as at least 50% improvement from baseline. Non responders at the end of the 8-week run-in period will be discontinued from the study.

Approximately 250 responders will be randomized (1:1 ratio) to enter the double-blind maintenance treatment period to receive crisaborole or vehicle QD for 52 weeks, with follow-up assessments every 4 weeks. If a flare occurs and if the participant meets the criteria for having a flare (ISGA ≥2), the participant will switch to enter a flare treatment period to receive open-label crisaborole BID for up to 12 weeks with follow-up assessments every 4 weeks. If the flare has resolved (ISGA ≤1) the participant will resume maintenance treatment and respective visit schedule. If a flare does not resolve after 3 consecutive treatment courses the participant will discontinue the study. A flare treatment period may comprise up to 3 consecutive treatment courses with crisaborole BID (each course is 4 weeks).

An end of study (EOS) safety follow-up is required 4 weeks after the last study treatment of any treatment period.

Enrollment: 620 patients

Sex: All

Ages: 3+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• 3 months of age and older
• Confirmed diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
• Minimum of 5% BSA affected by atopic dermatitis
• ISGA score of Mild (2) or Moderate (3)

Exclusion criteria

• Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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620 participants in 2 patient groups, including a placebo group

Crisaborole 2%

Experimental group

Description:

Crisaborole 2% ointment applied once daily (QD)

Treatment:

Drug: Crisaborole 2%

Vehicle

Placebo Comparator group

Description:

Vehicle ointment applied once daily (QD)

Treatment:

Drug: Vehicle