Study Evaluating Long-Term Maintenance Treatment and Flare Reduction with Crisaborole Ointment 2% in Pediatric and Adult Participants with Mild-to-Moderate Atopic Dermatitis
- Conditions
- Mild-to-Moderate Atopic DermatitisMedDRA version: 20.0Level: LLTClassification code 10003640Term: Atopic dermatitis and related conditionsSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-000443-28-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
Age
1. Participant must be 2 years of age or older at the time of signing the informed consent/assent.
Type of Participant and Disease Characteristics
2. Participant who meets the following AD criteria:
a. Confirmed clinical diagnosis of AD according to the criteria of Hanifin and Rajka (see Appendix 6).
b. AD treatment naïve, prior non-responder to emollient use, or has been previously treated with TCSs or TCIs.
c. AD involvement of =5% Treatable % BSA (excluding the scalp) (see Table 4) at entry into the run-in period.
d. ISGA score of Mild (2) or Moderate (3) at entry into the open-label run-in period.
Sex
3. Male or Female
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
a. Male participants:
No contraception methods are required for male participants in this study.
b. Female participants:
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
? OR
- Is a WOCBP and using an acceptable contraceptive method as described in Appendix 4 during the intervention period (at a minimum until after the last dose of study intervention). The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
- A WOCBP must have a negative highly sensitive (Appendix 2) pregnancy test (urine or serum as required by local regulations) within 7 days before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
* Additional requirements for pregnancy testing during and after study intervention are located in Appendix 2.
* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
Informed Consent
4. Capable of giving signed informed consent/assent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Are the trial subjects under 18? yes
Number of subjects for this age range: 420
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Medical Conditions
1. Participant 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) or clinically significant physical examination finding at Screening that in the investigator’s/designee’s opinion may interfere with study objectives (eg, expose participant to unacceptable risk by study participation, confound evaluation of treatment response or AEs, or interfere with participant’s ability to complete the study)
2. Participant has unstable AD or any consistent requirement for high-potency TCS to manage AD signs and symptoms
3. Participant has a significant active systemic or localized infection, including known actively infected AD
4. History of or active suicidal ideation or behavior, or chronic psychiatric abnormality that may increase the risk associated with study participation or study intervention or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study including the following:
a. For participants 7-11 years of age, suicidal ideation associated with actual
intent and a method or plan in the past 6 months: Yes” answers on items 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) (Section 8.2.6) or a previous history of suicidal behaviors in their lifetime:
Yes” answer to any of the suicidal behavior items of the C-SSRS.
b. For participants =12 years of age, suicidal ideation associated with actual intent and a method or plan in the past year: Yes” answers on items 4 or 5 of the C-SSRS (Section 8.2.6) or a previous history of suicidal behaviors in the past 5 years: Yes” answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS.
5. Participant has a history of cancer within 5 years or has undergone treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only).
6. Participant has a history of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the IPs.
7. Participant has a known lack of efficacy to crisaborole.
Prior/Concomitant Therapy
8. Participant has a history of use of biologic therapy including intravenous immunoglobulin or dupilumab at any time prior to study
9. Participant has recent or anticipated concomitant use of systemic therapies or therapies that might alter the course of AD, as specified in the protocol
10. Participant has received any of the prohibited medications/therapies that may alter the course of AD without the required minimum washout period (see Section 6.5.1) or anticipated concomitant use of any of the prohibited medications/therapy (see Section 6.5.2).
11. Participant has any planned surgical or medical procedure that would overlap with study participation, from Screening through the end of study.
Prior/Concurrent Clinical Study Experience
12. Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.
Diagnostic assessments
13. Other acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or study intervention administration
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method