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
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|ClinicalTrials.gov Identifier: NCT04040192|
Recruitment Status : Active, not recruiting
First Posted : July 31, 2019
Last Update Posted : May 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Crisaborole 2% Drug: Vehicle||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||482 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction With Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 3 Months and Older) With Mild-to-Moderate Atopic Dermatitis, Who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment|
|Actual Study Start Date :||September 12, 2019|
|Estimated Primary Completion Date :||February 15, 2022|
|Estimated Study Completion Date :||February 15, 2022|
Experimental: Crisaborole 2%
Crisaborole 2% ointment applied once daily (QD)
Drug: Crisaborole 2%
Crisaborole ointment 2%
Placebo Comparator: Vehicle
Vehicle ointment applied once daily (QD)
- Flare-free maintenance [ Time Frame: 52 Weeks ]Flare-free maintenance up until the onset of the first flare during the maintenance period. A flare is defined as a score of 2 or more on the Investigator Static Global Assessment (ISGA).
- Incidence of treatment emergent adverse events [ Time Frame: 52 weeks ]Incidence of treatment emergent adverse events over 52 weeks
- Number of flare-free days [ Time Frame: 52 Weeks ]Number of flare-free days over 52 weeks
- Number of flares [ Time Frame: 52 Weeks ]Number of flares over 52 weeks
- Pruritus response maintenance [ Time Frame: 52 Weeks ]Maintenance of pruritus scores of ≥50% until onset of first flare. A flare is defined as a score of ≥2 on the Investigator's Static Global Assessment (ISGA).
- Eczema Area and Severity Index (EASI) response maintenance [ Time Frame: 52 weeks ]Maintenance of ≥50% reduction in Eczema Area and Severity Index (EASI50) over 52 weeks
- Patient-reported outcome response maintenance [ Time Frame: 52 weeks ]Maintenance of Dermatology Quality of Life Assessments (DQoL) over 52 weeks
- Patient-reported outcome response maintenance [ Time Frame: 52 weeks ]Maintenance of Patient Oriented Eczema Measure (POEM) over 52 weeks
- Severity of flares [ Time Frame: 52 weeks ]Severity of flare on Investigator's Static Global Assessment (ISGA)
- Severity of flares [ Time Frame: 52 weeks ]Severity of flare on Eczema Area and Severity Index (EASI)
- Duration of flares [ Time Frame: 52 weeks ]Duration of flare episodes over 52 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040192
|Study Director:||Pfizer CT.gov Call Center||Pfizer|