Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Ruxolitinib 1.5% cream-Test (T): Dose: 15 mg of Ruxolitinib per gram (1.5%) supplied in 60 g and 100 g tubes
frequency: Twice daily in the morning and evening
Route of administration:
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Participant must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in Appendix 10.1.3 and in this protocol and is willing to participate in the study. 2) Male or female participants aged greater than or equal to 18 (completed years) at the time of signing the informed consent. 3) Participants with a clinical diagnosis of atopic dermatitis as defined by the Hanifin and Rajka criteria. 4) Participant must have diagnosis of atopic dermatitis for at least 3 months prior to baseline. (Participant may verbally report signs and symptoms of atopic dermatitis with an onset at least 3 months prior to the first dose of study intervention). 5) Participants with Investigator Global Assessment of Disease Severity of 2 (mild severity) or 3 (moderate severity) at screening and baseline. 6) Participant with affected area of atopic dermatitis involvement of between 3 percentage to 20 percentage (both inclusive) BSA at baseline. 7) Participants with documented recent history (within 1 year prior to screening visit) of inadequate response to treatment with medicated topical therapy for atopic dermatitis, or for whom other medicated topical therapies are otherwise medically inadvisable (eg, because of important side effects or safety risks). Participants verbal report of failure to treatments for AD is acceptable. NOTE: Medicated topical therapy is defined as a topical product that contains an active pharmaceutical ingredient indicated for the treatment of AD (irrespective of whether it is an over-the-counter or prescribed product). 8) 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) as defined in Appendix 4 OR Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least 30 days after the last dose of the study intervention. The Investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relation to the first dose of the study intervention. A WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for reproduction or retrieve them for their use during the recommended period of contraception. A WOCBP must have a negative highly sensitive urine pregnancy test within 24 hours before the first dose of the study intervention. If a urine test cannot be confirmed as negative (e.g., 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 Section 8.3.5.The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy. 9) Participant willing and able to adhere to the lifestyle restrictions specified in this protocol.
Exclusion criteria
Exclusion criteria: 1) Known allergies or hypersensitivity to any of the study interventions, or components/ excipients thereof (refer to the USPI of OPZELURA cream), or to pimecrolimus or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. 2) Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the Investigator in the 4 weeks prior to the first dose of study intervention. 3) Participants with concurrent conditions and history of other diseases: a) Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome). b) Active systemic infection (except common cold, fungal infections of nail beds) at baseline. c) Acute, chronic or recurrent infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before screening. d) A serious infection, defined as requiring hospitalization or intravenous anti-infective(s) within 4 weeks prior to screening. e) Any history of opportunistic infections that, in the opinion of the Investigator, might cause this study to be detrimental to the patient. Opportunistic infections are infections caused by uncommon pathogens or unusually severe infections caused by common pathogens as defined in Appendix 8: Examples of Infections that May Be Considered Opportunistic. f) Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected AD). g) Have evidence of active or latent infection with Mycobacterium tuberculosis (TB) as defined by the following: A history of either untreated or inadequately treated for latent or active TB infection will be excluded. Participants previously treated for active TB or latent TB, who have completed a successful course of treatment in accordance with national local medical guidelines or WHO guidelines with a documented result of cure prior to the first dose of study intervention, may be included. In such participants, neither an interferon-gamma release assay (IGRA) test nor a tuberculin skin test (TST) is needed, but a chest radiograph(s) is required, if not performed within 12 weeks prior to the first dose of study intervention. To be considered eligible for the study, the radiograph(s) must be negative for active tuberculosis infection as determined by a qualified radiologist. Documentation of cure and negative chest radiograph(s) results must be obtained prior to the first dose of study intervention. A participant who is currently being treated for active TB infection will be excluded. Participants currently receiving chemoprophylaxis for latent TB per national/local medical guidelines or WHO guidelines, who have documented treatment for at least 4 weeks before receiving study intervention on the first dose of study intervention may be included. Participants need to commit to completion of the chemoprophylaxis course. In such participants, neither an IGRA test nor a TST is needed, but a chest radiograph(s) is required, if not performed within 12 weeks prior to the first dose of study intervention. To be considered eligible for the study, the radiograph(s) must be negative for active tuberculosis infection as determined by a qualified radiologist. Documentation of ongoing therapy including compliance to therapy and negative chest radiograph(s) results must be obtained prior to the first dos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the therapeutic equivalence between Ruxolitinib-test and Ruxolitinib-reference in participants with mild to moderate atopic dermatitis. To establish superiority of Ruxolitinib-test and Ruxolitinib-reference over vehicle in participants with mild to moderate atopic dermatitis.Timepoint: Day 1, Day 8 and Day 15. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Ruxolitinib-test, Ruxolitinib-reference & vehicle in participants with mild to moderate atopic dermatitis.Timepoint: Day 1, Day 8 & Day 15.;To evaluate the safety of Ruxolitinib-test, Ruxolitinib-reference & vehicle in participants with mild to moderate atopic dermatitis.Timepoint: Day 1, Day 8 & Day 15. | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed