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
NCT04040192
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Adult Trials: 18+ Years
- 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)
- 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).
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | 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 | ||||||
| Official Title ICMJE | 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 | ||||||
| Brief Summary | 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. | ||||||
| Detailed 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. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Atopic Dermatitis | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE | 700 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | May 10, 2022 | ||||||
| Estimated Primary Completion Date | May 10, 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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). | ||||||
| Sex/Gender ICMJE |
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| Ages ICMJE | 3 Months and older (Child, Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Australia, Canada, China, Israel, Turkey, United States | ||||||
| Removed Location Countries | Austria, France, Spain | ||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04040192 | ||||||
| Other Study ID Numbers ICMJE | C3291035 2019-000443-28 ( EudraCT Number ) CRISADE CONTROL ( Other Identifier: Alias Study Number ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||||
| Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||