Ruxolitinib Cream for Eczema
(TRuE-AD4 Trial)
Recruiting in Palo Alto (17 mi)
+116 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Incyte Corporation
Must not be taking: Biologics, Systemic corticosteroids
Disqualifiers: Immunocompromised, Hepatitis B/C, HIV, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This study is being conducted to establish the efficacy of ruxolitinib cream in participants with moderate AD who had an inadequate response to, or are intolerant to, or contraindicated to topical corticosteroid (TCS)s and topical calcineurin inhibitor (TCI)s.
Will I have to stop taking my current medications?
Yes, you will need to stop taking medications used to treat eczema, except for those allowed in the study. There are specific timeframes for stopping certain medications, such as 4 weeks for systemic corticosteroids and 1 week for other topical treatments.
What data supports the effectiveness of the drug Ruxolitinib Cream for eczema?
Is Ruxolitinib Cream safe for use in humans?
How is the drug Ruxolitinib Cream different from other eczema treatments?
Ruxolitinib Cream is unique because it is a topical treatment that specifically targets Janus kinase (JAK) 1 and JAK2, which are involved in the inflammation process of eczema. This makes it an alternative to traditional treatments like corticosteroids and calcineurin inhibitors, offering a different mechanism of action to help reduce symptoms like itching and skin irritation.12345
Eligibility Criteria
Adults over 18 with moderate atopic dermatitis (AD) covering 10-20% of their body, not including the scalp. They must have had AD for at least two years and not responded well to or can't use topical steroids and calcineurin inhibitors. Participants need an IGA score of 3, EASI score above 7, significant itchiness, and a DLQI score over 10.Inclusion Criteria
I agree to stop all current Alzheimer's treatments except those allowed in the study.
EASI score > 7 at screening and Day 1
DLQI score > 10 at screening and Day 1
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Exclusion Criteria
I haven't taken antibiotics or antivirals in the last 2 weeks.
Any other concomitant skin disorder (eg, generalized erythroderma, such as Netherton syndrome), pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety
Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive ruxolitinib 1.5% cream or vehicle cream applied topically twice daily from Day 1 to Week 8 during the Vehicle Control (VC) Period
8 weeks
Regular visits for assessment
Extension
Participants continue applying ruxolitinib 1.5% cream or vehicle cream from Week 8 to 24 during the Vehicle Control Extension (VCE) Period
16 weeks
Regular visits for assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Treatment Details
Interventions
- Ruxolitinib Cream (Janus Kinase Inhibitor)
Trial OverviewThe trial is testing Ruxolitinib Cream against a placebo cream (Vehicle Cream) in adults with moderate AD who haven't seen improvement from standard treatments like topical steroids or are unable to use them due to intolerance or contraindications.
Participant Groups
5Treatment groups
Experimental Treatment
Placebo Group
Group I: VC Period: Ruxolitinib 1.5% Cream BIDExperimental Treatment1 Intervention
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the Vehicle Control (VC) Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Group II: VC Extension Period: Ruxolitinib 1.5% cream open-label escape armExperimental Treatment1 Intervention
Participants received ruxolitinib 1.5% cream, applied topically to the affected areas as a thin film twice daily (BID) during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Group III: VC Extension Period/Escape Arm: Ruxolitinib 1.5% Cream BIDExperimental Treatment1 Intervention
Participants who applied ruxolitinib 1.5% cream during VC Period, continued applying ruxolitinib 1.5% cream topically to the affected areas as a thin film BID from Week 8 to 24 during the Vehicle Control Extension (VCE) Period. Participants stopped treatment 3 days after lesions disappeared and restarted at the first sign of recurrence.
Group IV: VC Period: Vehicle Cream BIDPlacebo Group1 Intervention
Participants received vehicle cream, applied topically to the affected areas as a thin film twice daily (BID) from Day 1 to Week 8 during the VC Period. Participants applied cream BID to areas identified at Baseline even if the areas improved.
Group V: VC Extension Period/Escape Arm: Vehicle Cream BIDPlacebo Group1 Intervention
Participants who applied vehicle cream during the VC Period, continued applying vehicle cream as a thin film twice daily (BID) from Weeks 8 to 24 during the VCE Period. Participants applied cream BID to areas identified at Baseline even if the areas improved. Participants will be eligible to enter the ruxolitinib 1.5% cream open-label escape arm as defined in the protocol.
Ruxolitinib Cream is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Opzelura for:
- Atopic Dermatitis
- Vitiligo
🇪🇺 Approved in European Union as Jakavi for:
- Myelofibrosis
- Polycythaemia vera
- Steroid-refractory acute graft-versus-host disease
- Chronic graft-versus-host disease
- Non-segmental vitiligo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Entrust Clinical ResearchMiami, FL
Revival Research Institute, Llc TroyTroy, MI
Lynderm Research IncMarkham, Canada
Dermdox Center For DermatologySugarloaf, PA
More Trial Locations
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Who Is Running the Clinical Trial?
Incyte CorporationLead Sponsor
References
Evaluation of tolerability and efficacy of a topical emulgel containing nanoliposomal ruxolitinib phosphate in the treatment of mild atopic dermatitis: a before-after single group pilot study. [2022]Ruxolitinib is a JAK1/2 inhibitor, which inhibits the signal transduction of interferon-gamma, a cytokine implicated in the pathogenesis of atopic dermatitis (AD). In this before-after single group phase IIA pilot study, we investigated the efficacy of topical nanoliposomal ruxolitinib phosphate (RuxoLip) emulgel in mild AD.
A Maximum-Use Trial of Ruxolitinib Cream in Adolescents and Adults with Atopic Dermatitis. [2022]Ruxolitinib cream is a topical formulation of ruxolitinib, an inhibitor of Janus kinase 1 and Janus kinase 2.
Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis. [2023]Ruxolitinib cream 1.5% (OPZELURA™) is a topical formulation of ruxolitinib, a potent, selective inhibitor of Janus kinase (JAK)1 and JAK2. The targeting of these kinases is associated with therapeutic benefits in patients with atopic dermatitis (AD). In two identically designed, multinational, phase III studies in patients aged ≥ 12 years with mild to moderate AD, ruxolitinib cream 1.5% improved measures of disease severity, pruritus and sleep disturbance relative to vehicle cream when applied twice daily for 8 weeks. Disease severity was controlled for the next 44 weeks when applied as needed to active lesions. Ruxolitinib cream 1.5% was well tolerated in this patient population; its safety profile was similar to that of vehicle cream over the short term, with the types of treatment-emergent adverse events typical of those seen in the vehicle-controlled period over the longer term. Moreover, application site treatment-emergent adverse events indicative of skin tolerability issues (e.g. stinging/burning sensation) were infrequent and no safety findings suggestive of systemic JAK inhibition were identified. Although further longer-term data would be of use, ruxolitinib cream 1.5% provides an alternative to established topical agents (e.g. corticosteroids and calcineurin inhibitors) for the treatment of mild to moderate AD in adults and adolescents.
Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis. [2023]Ruxolitinib cream is a topical formulation of ruxolitinib, a Janus kinase (JAK) 1/JAK2 inhibitor.
Clinically relevant improvements in adults and adolescents with atopic dermatitis who did not achieve Investigator's Global Assessment treatment success following 8 weeks of ruxolitinib cream monotherapy. [2023]Ruxolitinib cream is a topical formulation of ruxolitinib, a selective inhibitor of Janus kinase (JAK) 1 and JAK2. In two phase 3 studies in adults and adolescents (aged ≥12 years) with atopic dermatitis (AD; TRuE-AD1/TRuE-AD2), significantly more patients who applied ruxolitinib cream versus vehicle cream achieved Investigator's Global Assessment treatment success (IGA-TS; IGA score of 0/1 with ≥2-point improvement from baseline) at week 8 (primary endpoint). This post hoc analysis evaluated the efficacy, safety, and disease control of ruxolitinib cream in patients with AD who did not achieve IGA-TS at week 8. Patients in TRuE-AD1/TRuE-AD2 (N = 1249) were randomized 2:2:1 to apply twice-daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, or vehicle cream for 8 weeks followed by a long-term safety period in which patients applied ruxolitinib cream as needed. In this pooled analysis, clinically meaningful response thresholds included ≥50% improvement in the Eczema Area and Severity Index, ≥2-point reduction in the Itch Numerical Rating Scale, ≥4-point improvement in the Dermatology Life Quality Index (DLQI) or ≥6-point improvement in Children's DLQI, and ≥1-point reduction in IGA from baseline. Among patients who did not achieve IGA-TS at week 8 (n = 584), significantly more patients who applied either strength ruxolitinib cream versus vehicle achieved each response threshold at week 8. A response in ≥1 clinically meaningful endpoint was achieved in significantly more patients who applied ruxolitinib cream (93.4%/90.9% for 0.75%/1.5% ruxolitinib cream, respectively) versus vehicle (69.0%, both P
Off-label Studies on the Use of Ruxolitinib in Dermatology. [2021]Ruxolitinib (Jakafi) is a Janus kinase 1 and 2 small molecule inhibitor that the Food and Drug Administration approved for myelofibrosis and polycythemia vera. It has been expanded to off-label treatment for a variety of dermatologic conditions, with several clinical trials ongoing. A review of available studies and cases of off-label uses was performed to guide clinicians seeking evidence on the efficacy of this Janus kinase inhibitor for dermatologic disorders.
Erythematous skin lesions with necrotic centers on lower extremities due to the use of ruxolitinib for primary myelofibrosis. [2021]Ruxolitinib is a small molecule JAK-2 inhibitor approved for the treatment of certain myeloproliferative neoplasms. Ruxolitinib-related skin toxicity is extremely rare. We report herein an unusual erythematous skin eruption with necrotic centers involving lower extremities in a patient with primary myelofibrosis treated with ruxolitinib. Awareness of this unusual skin toxicity with ruxolitinib becomes even more important as JAK-2 inhibition might soon find clinical applications in dermatology.
Management of Atopic Dermatitis: Clinical Utility of Ruxolitinib. [2022]Atopic dermatitis (AD) is a common chronic, pruritic inflammatory skin disease that profoundly impacts patients' quality of life. As the first FDA-approved topical JAK inhibitor, ruxolitinib 1.5% cream represents a novel therapeutic topical agent for the treatment of AD. The objective of this review is to summarize the efficacy and safety of ruxolitinib cream in patients with AD based on the available evidence. Overall, ruxolitinib cream demonstrated high efficacy and a favorable safety profile for treating atopic dermatitis.
Long-Term Safety Profile and Off-Label Use of JAK Inhibitors in Dermatological Disorders. [2023]JAK inhibitors target specific inflammatory cytokines involved in various inflammatory diseases. Four molecules have been approved for dermatological use: upadacitinib, baricitinib, abrocitinib and topical ruxolitinib. Off-label prescriptions for other dermatological conditions have been reported. We conducted a narrative review of the literature to assess the long-term safety profile of currently approved JAK inhibitors in dermatology, and their off-label use in skin disorders. We performed literature searches with Pubmed and Google Scholar from January 2000 to January 2023, using the keywords "Janus kinase inhibitors", "JAK inhibitors", "off-label", "dermatology", "safety", "adverse events", "ruxolitinib", "upadacitinib", "abrocitinib" and "baricitinib". Our search yielded a total of 37 dermatological disorders with studies supporting the use of these JAK inhibitors. Preliminary studies indicate that JAK inhibitors generally have a favorable safety profile and can be considered as an option in many dermatological disorders.