Ruxolitinib Cream for Discoid Lupus
Recruiting in Palo Alto (17 mi)
+1 other location
RB
Overseen byRobert Bissonnette, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Innovaderm Research Inc.
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.
Do I have to stop taking my current medications?
The trial requires that you stop using any topical medicated treatments that could affect discoid lupus erythematosus (DLE) within 2 weeks before starting the study. This includes topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices. Additionally, you must not have received any biological agents within 12 weeks or 5 half-lives before the study. The protocol does not specify other medications, so it's best to discuss with the study team.
What data supports the idea that Ruxolitinib Cream for Discoid Lupus is an effective treatment?
The available research does not provide specific data on the effectiveness of Ruxolitinib Cream for Discoid Lupus. However, it mentions other treatments like tacrolimus ointment and rapamycin, which have shown effectiveness in treating Discoid Lupus. Tacrolimus was found to be as effective as another treatment, triamcinolone acetonide, in reducing symptoms, while rapamycin showed a positive response in a case resistant to other treatments. This suggests that while Ruxolitinib Cream's effectiveness isn't directly supported by the data, other similar treatments have shown promise.12345
What safety data exists for Ruxolitinib cream?
Ruxolitinib cream, also known as Opzelura, has been evaluated for safety in various dermatological conditions such as atopic dermatitis, vitiligo, psoriasis, and lichen planus. In studies, it was well tolerated with a safety profile similar to vehicle cream, showing minimal bioavailability and low rates of mild-to-moderate treatment-related adverse events. Common adverse effects include application site acne, itching, redness, and systemic effects like headache and fever. No significant systemic JAK inhibition safety concerns were identified.678910
Is Ruxolitinib 1.5% Cream a promising drug for Discoid Lupus?
Research Team
RB
Robert Bissonnette, MD
Principal Investigator
Innovaderm Research Inc.
Eligibility Criteria
This trial is for adults with discoid lupus erythematosus, a chronic skin condition. Participants should have stable disease and be willing to apply cream treatments as directed. Specific eligibility details are not provided, but typically trials exclude those with certain health conditions or who are taking conflicting medications.Inclusion Criteria
I am a woman who can have children and have tested negative for pregnancy.
I am willing and able to give my consent to participate in the study.
Subjects must be willing to comply with all study procedures and must be available for the duration of the study
See 3 more
Exclusion Criteria
Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening
Subject is known to have immune deficiency or is immunocompromised
Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1
See 9 more
Treatment Details
Interventions
- Ruxolitinib 1.5% Cream (Topical Therapy)
Trial OverviewThe study tests the effectiveness of Ruxolitinib 1.5% cream in treating discoid lupus erythematosus. It's a single-blind study where participants use the cream normally on some lesions and under occlusion (covered) at night on others to compare results.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: ruxolitinib 1.5% cream (Sequence 1)Experimental Treatment3 Interventions
ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2
Group II: ruxolitinib 1.5% cream ( Sequence 2)Experimental Treatment3 Interventions
ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2
Ruxolitinib 1.5% Cream is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Opzelura for:
- Atopic dermatitis
- Nonsegmental vitiligo
🇪🇺 Approved in European Union as Opzelura for:
- Atopic dermatitis
- Nonsegmental vitiligo
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
INNO-6051 Site 03Fredericton, Canada
Innovaderm Research Inc.Montréal, Canada
Loading ...
Who Is Running the Clinical Trial?
Innovaderm Research Inc.
Lead Sponsor
Trials
49
Patients Recruited
3,200+
References
Open-Label Phase 2 Pilot Study of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE). [2023]Alsukait S, Learned C, Rosmarin D. Open-label phase 2 pilot study of oral tofacitinib in adult subjects with Discoid Lupus Erythematosus (DLE). J Drugs Dermatol. 2023;22(4): 425-427. doi:10.36849/JDD.7098.
Effectiveness of topical calcineurin inhibitors as monotherapy or in combination with hydroxychloroquine in cutaneous lupus erythematosus. [2014]Calcineurin inhibitors show potent anti-inflammatory effects and favorable safety profile when used in the treatment of cutaneous lupus erythematosus (CLE).
Lenalidomide for the treatment of resistant discoid lupus erythematosus. [2021]Discoid lupus erythematosus (DLE) is a chronic, disfiguring disease that is characterized by scaly, erythematous, disk-shaped patches and plaques followed by atrophy, scarring, and dyspigmentation. It is refractory to standard therapies in a small population of patients. We investigated the use of lenalidomide, a thalidomide analogue, as a novel alternative therapy in 2 cases of refractory DLE and report our results.
Tacrolimus 0.03% ointment in labial discoid lupus erythematosus: A randomized, controlled clinical trial. [2015]In this randomized, controlled clinical trial to compare efficacy and safety, 41 patients with labial discoid lupus erythematosus (DLE) were randomized to 2 groups, either receiving tacrolimus 0.03% ointment (n = 22) or triamcinolone acetonide 0.1% cream (n = 19). Each patient was treated with 3, 2, and 1 daily doses in the first, second, and third weeks, respectively, for 1 course. After the 3 week treatment, patients with complete disappearance of erosion were followed up for 3 months. After the 3 week application, 20 participants in the tacrolimus group and 19 in the triamcinolone acetonide group completed the study. The rates of complete response were 70% and 89.5% in tacrolimus-treated and triamcinolone acetonide-treated patients, respectively, with no significant difference (P = .235). Reduction in erosion and erythema showed no significant difference between groups (P > .05). Final reduction in reticulation areas and numeric rating scale scores were significantly greater in the tacrolimus group than in the triamcinolone acetonide group (P = .013; P = .048, respectively). Only 1 patient receiving tacrolimus presented with slight discomfort. There was no significant difference in 3 month recurrence rate between the groups (P > .05). Topical tacrolimus is considered as effective as triamcinolone acetonide for the management of labial DLE.
Rapamycin for refractory discoid lupus erythematosus. [2019]Generalized discoid lupus erythematosus can pose a therapeutic challenge for dermatologists. Current treatment emphasizes photoprotection, topical and systemic steroids, and steroid-sparing immunosuppressive agents if necessary. Rapamycin, also known as sirolimus, selectively inhibits mammalian target of rapamycin, a regulatory kinase responsible for multiple signal transduction pathways. Mammalian target of rapamycin inhibition reduces cell division, lymphocyte proliferation, cytokine release, and downstream pathways unique from other classes of immunomodulatory drugs. Herein, we present a case of generalized discoid lupus erythematosus resistant to topical steroids, prednisone, azathioprine, mycophenolate mofetil, hydroxychloroquine, and thalidomide. The addition of rapamycin led to a positive treatment response within 6 weeks, with good tolerance of the medication and no adverse effects. The current literature supporting the use of rapamycin in the treatment of autoimmune connective tissue diseases is also briefly reviewed. For patients with severe or generalized discoid lupus erythematosus refractory to conventional treatment, rapamycin may be a useful therapeutic consideration.
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.
New Indication for Topical Ruxolitnib. [2023]The Food and Drug Administration has approved the Janus kinase inhibitor ruxolitnib (Opzelura) as topical treatment for nonsegmental vitiligo in children and adults ages 12 years and older.The most common adverse effects are application site acne, application site itching, common cold, headache, urinary tract infection, application site redness, and fever.
Utilization of Topical Ruxolitinib in Dermatology: A Review. [2023]As systemic administration of Janus kinase-inhibitors is associated with safety concerns, local alternatives, such as topical ruxolitinib, have been developed. This review summarizes utilization of topical ruxolitinib in dermatology. A literature search was performed of studies reporting topical use of ruxolitinib in dermatologic conditions. Twenty-four articles were included, representing 2618 patients. Results show improvement with topical ruxolitinib formulations in atopic dermatitis, vitiligo, psoriasis, and lichen planus. Results are conflicting in alopecia areata. Minimal bioavailability and low rates of mild-to-moderate treatment-related adverse events support a favorable safety profile and higher tolerability of topical ruxolitinib compared to oral Janus kinase-inhibitors.
Ruxolitinib Cream in the Treatment of Cutaneous Lichen Planus: A Prospective, Open-Label Study. [2022]Ruxolitinib is a Janus kinase 1/2 inhibitor that blocks signal transduction of interferon-gamma, a critical cytokine involved in the pathogenesis of cutaneous lichen planus (LP). In this prospective phase II study, we investigated the efficacy of topical ruxolitinib in cutaneous LP and performed transcriptomic analysis before and after therapy. Twelve patients with cutaneous LP applied topical ruxolitinib twice daily for 8 weeks. Primary endpoints were changes in total lesion count and changes in modified Composite Assessment of Index Lesion Severity score in index treated and untreated index control lesions at week 4. Total lesion count decreased by a median of 50 lesions (interquartile range 25, 723; P
Review of Ruxolitinib in the Treatment of Atopic Dermatitis. [2023]To review the pharmacokinetics, efficacy, and safety of a newly approved topical Janus kinase 1 (JAK) inhibitor, ruxolitinib (RUX), in patients with atopic dermatitis (AD).
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.
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.
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