CTRI/2025/05/087871尚未招募3 期
A Randomized, Double-Blind, Phase 3, Placebo-Controlled, Three-Arm, Parallel Study to Establish Therapeutic Equivalence of Ruxolitinib 1.5 Percent cream of Intas Pharmaceuticals Limited compared with OpzeluraTM 1.5 Percent cream in Adult Participants with Mild to Moderate Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 270
- 试验地点
- 11
- 主要终点
- To establish superiority of Ruxolitinib-test and Ruxolitinib-reference over vehicle in participants with mild to moderate atopic dermatitis.
研究概览
简要总结
A study to establish the therapeutic equivalence between Ruxolitinib-test and Ruxolitinib-reference in participants with mild to moderate atopic dermatitis and to establish superiority of Ruxolitinib-test and Ruxolitinib-reference over vehicle in participants with mild to moderate atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •Male or female participants aged greater than or equal to 18 (completed years) at the time of signing the informed consent.
- •Participants with a clinical diagnosis of atopic dermatitis as defined by the Hanifin and Rajka criteria.
- •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).
- •Participants with Investigator Global Assessment of Disease Severity of 2 (mild severity) or 3 (moderate severity) at screening and baseline.
- •Participant with affected area of atopic dermatitis involvement of between 3 percentage to 20 percentage (both inclusive) BSA at baseline.
- •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).
- •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.
- •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.
- •Participant willing and able to adhere to the lifestyle restrictions specified in this protocol.
排除标准
- •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.
- •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.
- •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.
- •Documentation of ongoing therapy including compliance to therapy and negative chest radiograph(s) results must be obtained prior to the first dose of study intervention.
- •A participant with latent TB may be rescreened.
- •A positive IGRA test (not indeterminate) or positive tuberculin skin test (TST) performed at or within the 12 weeks prior to the first dose of study intervention is exclusionary a negative test is required for eligibility.
- •If a participant had a negative IGRA within 12 weeks prior to the first dose of study intervention and source documentation is available, the test does not need to be repeated, provided nothing has changed in the participants medical history to warrant a repeat test.
- •Participants who are determined to have a false positive IGRA test result by the specialist are eligible to enroll.
- •Known close contact with a person with active TB within 12 weeks of the first dose of study intervention.
- •Such participant may be eligible if he/she undergoes additional evaluation and, if warranted, receives appropriate treatment for latent TB per national local medical guidelines or WHO guidelines for at least 4 weeks before receiving study intervention on the first dose of study intervention without evidence of active TB (negative chest radiograph as determined by a qualified radiologist).
- •NOTE: It is the responsibility of the Investigator to verify the adequacy of previous TB treatment and provide obtain appropriate documentation.
- •h) Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton syndrome), sunburn, pigmented lesion(s), or extensive scarring in any treatment area at baseline that, in the opinion of the Investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
- •i) Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds.
- •j) History of confounding skin conditions (e.g., psoriasis, rosacea, erythroderma, or ichthyosis) or other types of eczema.
- •Participants using any of the following treatments within the indicated washout period before first dose of study intervention or planned use during study treatment phase: a) 5 half-lives or 12 weeks, whichever is longer – Biologic agents for treatment of AD.
- •b) One month – 1) oral or intravenous corticosteroids, 2) ultraviolet A (UVA) ultraviolet B (UVB) therapy, 3) psoralen plus ultraviolet A (PUVA) therapy, 4) tanning booths, 5) sun lamps or nonprescription ultraviolet (UV) light sources, 6) Systemic immunomodulators or immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) tacrolimus (systemic), 10) pimecrolimus, 11) Ruxolitinib or other JAK inhibitor (topical or systemic), or 12) Allergen immunotherapy.
- •d) 7 days – 1) antihistamines, 2) topical antibiotics antifungal, 3) topical corticosteroids or 4) other topical drug products like coal tar (shampoo), antibacterial cleansing body wash soap, other topical treatments for AD including PDE4-inhibitors like crisaborole, tacrolimus (topical), aryl hydrocarbon receptor agonist (tapinarof) e) 24 hours – any topical product other than the assigned treatment (e.g., sunscreen, new brand of cosmetic or cleanser, cream, lotion, ointment, powder, or bland emollient) applied on or near the treatment area(s).
- •f) Not willing to minimize or avoid natural and artificial sunlight exposure during treatment.
- •g) Inhibitor of CYP3A4 within duration equal to 5 half-lives of the CYP3A4 inhibitor prior to the first dose of study intervention h) Live or live-attenuated vaccination during the study 5) Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of investigational intervention.
- •NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.
- •Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- •Participant with clinically significant current or recent (within the past 6 months before the first dose of study intervention) cardiac conditions as defined below: a) Unstable angina, stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event or thromboembolic event (e.g., deep vein thrombosis [DVT], pulmonary embolism) b) Clinical risk assessment of cardiac function using the New York Heart Association Functional Classification of Class III or greater c) Serious cardiac arrhythmia not controlled by adequate medication d) Electrocardiographic evidence of acute ischemic or active conduction system abnormalities at screening e) Any other cardiac illness that could lead to a safety risk to the participant f) Participants with known coronary artery disease, congestive heart failure must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate 10) Received an investigational intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer.
- •Previous randomization in the current study regardless of having received study intervention or not.
- •Documented medical history or presence of immunological deficiencies or diseases, clinically significant or uncontrolled cardiovascular disease, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency, severe hepatic disorders, or any other condition that in the Investigator’s opinion may put the subject at increased risk (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
结局指标
主要结局
To establish superiority of Ruxolitinib-test and Ruxolitinib-reference over vehicle in participants with mild to moderate atopic dermatitis.
时间窗: Day 1, Day 8 and Day 15.
To establish the therapeutic equivalence between Ruxolitinib-test and Ruxolitinib-reference in participants with mild to moderate atopic dermatitis.
时间窗: Day 1, Day 8 and Day 15.
次要结局
- To evaluate the efficacy of Ruxolitinib-test, Ruxolitinib-reference & vehicle in participants with mild to moderate atopic dermatitis.(Day 1, Day 8 & Day 15.)
- To evaluate the safety of Ruxolitinib-test, Ruxolitinib-reference & vehicle in participants with mild to moderate atopic dermatitis.(Day 1, Day 8 & Day 15.)
研究者
研究点 (11)
Loading locations...
相似试验
终止
3 期
Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)COVID-19NCT04377620Incyte Corporation211
已完成
3 期
COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I TrialMPN (Myeloproliferative Neoplasms)NCT00952289Incyte Corporation309
终止
3 期
A Study of Ruxolitinib in Pancreatic Cancer PatientsPancreatic CancerNCT02119663Incyte Corporation86
终止
3 期
Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)Pancreatic CancerNCT02117479Incyte Corporation321
已完成
3 期
A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)Graft-versus-host Disease (GVHD)NCT03112603Incyte Corporation330