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- ||| Zoryve foam (topical roflumilast foam) / Arcutis
Enrollment open, Phase classification, Enrollment change, Trial completion date, Trial primary completion date: An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV) (clinicaltrials.gov) - Aug 18, 2025
P2, N=20, Recruiting, Sponsor: Derm Texas, PLLC
Not yet recruiting --> Recruiting | Phase classification: PN/A --> P2 | N=35 --> 20 | Trial completion date: Aug 2027 --> Jun 2026 | Trial primary completion date: Aug 2027 --> May 2026
- | Journal: New molecules in the therapy of chronic graft-versus-host disease. (Pubmed Central) - Aug 13, 2025
Expanding therapeutic options in cGvHD require decision-making based on organ involvement, prior therapy, and tolerability. Emerging compounds offer the potential to modulate chronic inflammation and fibrosis more precisely, supporting a move toward personalized and combinatorial approaches in advanced-line settings.
- | Zoryve (roflumilast cream) / Arcutis
Journal: Treatment of Recalcitrant Scalp Psoriasis with Topical Roflumilast Cream 0.3%: A Case Report. (Pubmed Central) - Aug 8, 2025
Here, we present the case of a 28-year-old female patient with scalp psoriasis, who had previously trialed both topical and systemic treatments for her disease without success. Use of once daily roflumilast 0.3% cream resulted in rapid scalp psoriasis clearance, with results seen as early as Day 3 and complete clearance by Day 5 of treatment without adverse events or tolerability concerns.
- | AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma
New P4 trial: A prospective clinical study on advanced or metastatic non-small cell lung cancer in the first-line treatment of adebelimab combined with emacetinib +/- chemotherapy (EUDRACT) - Aug 6, 2025
P4, N=68, Not yet recruiting, Sponsor: Henan Cancer Hospital; Henan Cancer Hospital
- || Zoryve foam (topical roflumilast foam) / Arcutis
New P2 trial, New trial: An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV) (clinicaltrials.gov) - Aug 6, 2025
P=N/A, N=35, Not yet recruiting, Sponsor: Derm Texas, PLLC
- Zoryve (roflumilast cream) / Arcutis
Efficacy and Tolerability of Roflumilast Cream 0.3% and Foam 0.3% in Patients With Plaque Psoriasis Involving the Face and/or Genitals: Outcomes From the Phase 3 DERMIS-1/2 and ARRECTOR Trials (Poster Area) - Jul 23, 2025 - Abstract #EADV2025EADV_5389;
- Zoryve (roflumilast cream) / Arcutis
Caregiver-Reported Outcomes From the Phase 3 INTEGUMENT-PED Trial of Children Aged 2 (Poster Area) - Jul 23, 2025 - Abstract #EADV2025EADV_2551;
- AiSuDa (ivarmacitinib) / Jiangsu Hengrui Pharma, Arcutis
A Multi-Cohort, Phase II Study of SHR0302 Combined With PD-1/PD-L1 Inhibitior for Treatment Na (Exhibit Hall) - Jul 22, 2025 - Abstract #IASLCWCLC2025IASLC_WCLC_2009;
Both cohorts will be treated until patients experienced disease progression, intolerable toxicity, or met the criteria for discontinuation of the trial drug. The primary endpoint of this trial is progression - free survival (PFS), while the secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
- ||| Zoryve foam (topical roflumilast foam) / Arcutis
Clinical, P3 data, Journal: Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial. (Pubmed Central) - Jul 16, 2025
P3
These results demonstrate the potential of roflumilast foam, 0.3%, as monotherapy for patients with psoriasis of the scalp and body. ClinicalTrials.gov Identifier: NCT05028582.
- ||| AiSuDa (ivarmacitinib) / Jiangsu Hengrui Pharma, Arcutis
Clinical, P3 data, Journal: Ivarmacitinib for Moderate to Severe Atopic Dermatitis in Adults and Adolescents: A Phase 3 Randomized Clinical Trial. (Pubmed Central) - Jul 16, 2025
P3
These results support the potential of ivarmacitinib as a new therapeutic option. ClinicalTrials.gov Identifier: NCT04875169.
- | Keytruda (pembrolizumab) / Merck (MSD), Zoryve (roflumilast cream) / Arcutis
Journal: The Treatment of Pembrolizumab-Induced Pruritus with Topical Roflumilast Cream 0.3% Once Daily. (Pubmed Central) - Jun 20, 2025
In 2024, roflumilast was FDA-approved in a 0.15% cream vehicle for treatment of mild-to-moderate atopic dermatitis in patients six years of age and older. In this adult patient, pruritus was improved within 48 hours after initiation of roflumilast cream 0.3% applied once daily and continued to be effective with use over time.
- | Journal: Focused update: Guidelines of care for the management of atopic dermatitis in adults. (Pubmed Central) - Jun 18, 2025
In this adult patient, pruritus was improved within 48 hours after initiation of roflumilast cream 0.3% applied once daily and continued to be effective with use over time. The workgroup developed strong recommendations for the use of tapinarof cream, roflumilast cream, lebrikizumab, and nemolizumab with concomitant topical therapy.
- ||| Zoryve (roflumilast cream) / Arcutis
Enrollment open: Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis (clinicaltrials.gov) - Jun 17, 2025
P2, N=100, Recruiting, Sponsor: Arcutis Biotherapeutics, Inc.
The workgroup developed strong recommendations for the use of tapinarof cream, roflumilast cream, lebrikizumab, and nemolizumab with concomitant topical therapy. Not yet recruiting --> Recruiting
- ||| ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Clinical, P2/3 data, Journal: Efficacy and Safety of Ivarmacitinib, a Selective JAK1 Inhibitor, in Patients with Active Ankylosing Spondylitis: Results from an Adaptive Seamless Phase II/III Trial. (Pubmed Central) - Jun 13, 2025
Ivarmacitinib 4 mg significantly improved the signs and symptoms of AS at week 12 compared to placebo, with sustained efficacy through 24 weeks and a tolerable safety profile. These findings support ivarmacitinib 4 mg as a new treatment option for active AS.
- Zoryve foam (topical roflumilast foam) / Arcutis
Roflumilast foam 0.3% for the treatment of seborrheic dermatitis in patients with diverse skin types: subgroup analyses of the phase 3 STRATUM trial (W05-W06) - Jun 12, 2025 - Abstract #EADV2025EADV_895;
- | Zoryve (roflumilast cream) / Arcutis
Retrospective data, Review, Journal: Efficacy and Safety of Roflumilast Cream in Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. (Pubmed Central) - Jun 8, 2025
This systematic review and meta-analysis evaluated the efficacy and safety of roflumilast cream in treating atopic dermatitis (AD) by analysing data from three randomised controlled trials. The results demonstrated significant improvement in treatment success with roflumilast compared to vehicle creams, with a modest increase in mild adverse events, supporting its potential as an effective and well-tolerated treatment for AD.
- || Zoryve foam (topical roflumilast foam) / Arcutis
Review, Journal: Need for Speed: Topical Roflumilast for Rapid Control of Seborrheic Dermatitis Flares. (Pubmed Central) - Jun 4, 2025
Topical roflumilast 0.3% foam is the most recent treatment for seborrheic dermatitis approved by the US Food and Drug Administration (FDA); however, its speed of action in controlling flares has not been fully explored...2025;24(6):634-635. doi:10.36849/JDD.8619.
- |||| Zoryve (roflumilast cream) / Arcutis
New P2 trial: Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis (clinicaltrials.gov) - Jun 2, 2025
P2, N=100, Not yet recruiting, Sponsor: Arcutis Biotherapeutics, Inc.
- ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
EFFICACY OF IVARMACITINIB IN BIOLOGICAL DMARDS-NA () - May 28, 2025 - Abstract #EULAR2025EULAR_3953;
P3
doi:10.36849/JDD.8619. Ivarmacitinib effectively reduces disease activity and improves health-related quality of life in bDMARDs-na
- | AiSuDa (ivarmacitinib) / Jiangsu Hengrui Pharma, Arcutis
New P2 trial: SHR0302 Combined With PD-1/PD-L1 Inhibition for Treatment na (clinicaltrials.gov) - Apr 14, 2025
P2, N=86, Not yet recruiting, Sponsor: Chunxia Su
- | Tremfya (guselkumab) / J&J, Zoryve (roflumilast cream) / Arcutis
Journal: Roflumilast Cream 0.3% for a Patient With Genital Psoriasis Refractory to Other Topical and Systemic Treatments: A Case Report. (Pubmed Central) - Apr 11, 2025
At 16 weeks, genital and gluteal cleft disease remained well-controlled with no evidence of active disease. Overall, roflumilast cream 0.3% was well tolerated with no pruritus, folliculitis, irritation, or contact dermatitis observed.
- || AiSuDa (ivarmacitinib) / Jiangsu Hengrui Pharma, Arcutis
Trial completion: A SHR0302 BA Study on Healthy Subjects (clinicaltrials.gov) - Apr 2, 2025
P1, N=16, Completed, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall, roflumilast cream 0.3% was well tolerated with no pruritus, folliculitis, irritation, or contact dermatitis observed. Active, not recruiting --> Completed
- ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Ivarmacitinib improves different dimensions of patient-reported outcomes in patients with active ankylosing spondylitis: a post-hoc analysis of a phase II/III trial (Poster Tour IV) - Mar 30, 2025 - Abstract #EULAR2025EULAR_1668;
P2/3
Ivarmacitinib significantly enhances multiple dimensions of PROs in active AS patients, supporting its utility in managing PROs in AS. Switching to Ivarmacitinib also provides substantial benefits, ensuring that patients who delay initiation of Ivarmacitinib also experience meaningful improvements in PROs.
- ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Efficacy of Ivarmacitinib in patients with active ankylosing spondylitis stratified by baseline characteristics: a post-hoc analysis of a phase II/III trial (Poster Area) - Mar 30, 2025 - Abstract #EULAR2025EULAR_866;
P2/3
Switching to Ivarmacitinib also provides substantial benefits, ensuring that patients who delay initiation of Ivarmacitinib also experience meaningful improvements in PROs. Ivarmacitinib significantly improves treatment response in active AS across subgroups, especially in those with younger age, lower BMI, shorter disease duration, and without a history of biological/JAK inhibitors.
- ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Ivarmacitinib reduces the need for concomitant medication in moderate-to-severe rheumatoid arthritis patients: a post-hoc analysis from a phase III trial (Poster Area) - Mar 30, 2025 - Abstract #EULAR2025EULAR_424;
P3
Ivarmacitinib significantly improves treatment response in active AS across subgroups, especially in those with younger age, lower BMI, shorter disease duration, and without a history of biological/JAK inhibitors. Ivarmacitinib reduces the need for additional RA medications, thereby decreasing treatment burden.
- ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Effect of Ivarmacitinib on patient-reported outcomes in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: a post hoc analysis of a phase III trial (Poster Area) - Mar 30, 2025 - Abstract #EULAR2025EULAR_422;
P3
Ivarmacitinib reduces the need for additional RA medications, thereby decreasing treatment burden. Ivarmacitinib significantly and sustained improves patient-reported outcomes in patients with moderate-to-severe RA who have not responded well to csDMARDs.
- | ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Journal: SHR0302 Improves Treg/Th17 Imbalance in Patients with Systemic Lupus Erythematosus. (Pubmed Central) - Mar 24, 2025
In addition, frequency of Th17 cells were reduced by SHR0302. Our study shows that SHR0302 regulating the JAK1/STAT3 pathway can be a new treatment option for SLE.
- ||| Enrollment open: A Trial of SHR0302Base in Patients With Vitiligo (clinicaltrials.gov) - Mar 19, 2025
P2, N=152, Recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Our study shows that SHR0302 regulating the JAK1/STAT3 pathway can be a new treatment option for SLE. Not yet recruiting --> Recruiting
- || Daliresp (roflumilast) / AstraZeneca
Review, Journal: Roflumilast for the Treatment of Seborrheic Dermatitis: A Review. (Pubmed Central) - Mar 12, 2025
Recent clinical trials have validated the efficacy of non-steroidal roflumilast 0.3% foam for the treatment of SD. In this review, we analyze the safety and efficacy profile of roflumilast 0.3% foam.
- | Vtama (tapinarof) / Organon, Opzelura (ruxolitinib cream) / Incyte
Journal: Tapinarof cream (Vtama) for atopic dermatitis. (Pubmed Central) - Feb 27, 2025
In this review, we analyze the safety and efficacy profile of roflumilast 0.3% foam. No abstract available
- ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Ivarmacitinib provides rapid and continuous improvement in patients with moderate-to-severe atopic dermatitis: a focus on different anatomical body regions () - Feb 26, 2025 - Abstract #AAD2025AAD_3373;
P3
No abstract available Ivarmacitinib treatment provides rapid and continuous improvement in patients with moderate-to-severe AD in different anatomical body regions.
- ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Effects of ivarmacitinib on itch and sleep improvements and their impact on quality of life in patients with moderate-to-severe atopic dermatitis: a post-hoc analysis of a phase III trial () - Feb 21, 2025 - Abstract #AAD2025AAD_2967;
P3
Ivarmacitinib treatment provides rapid and continuous improvement in patients with moderate-to-severe AD in different anatomical body regions. Ivarmacitinib treatment improves both itch and sleep, and these improvements are associated with better QoL in patients with moderate-to-severe AD.
- ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Ivarmacitinib in patients with moderate-to-severe atopic dermatitis, stratified by baseline characteristics: a post-hoc analysis of a phase 3 clinical trial () - Feb 21, 2025 - Abstract #AAD2025AAD_2961;
Ivarmacitinib demonstrates substantial benefits across subgroups of M-SAD patients. Switching from placebo to ivarmacitinib also provides considerable benefits across patient subgroups.
- ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Efficacy and safety of Ivarmacitinib in moderate-to-severe atopic dermatitis patients with prior systemic therapy: a post-hoc analysis of a phase III trial () - Feb 21, 2025 - Abstract #AAD2025AAD_2937;
P3
Switching from placebo to ivarmacitinib also provides considerable benefits across patient subgroups. Ivarmacitinib demonstrates a good efficacy and safety profile in moderate-to-severe atopic dermatitis patients with prior systemic therapy.
- ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Efficacy and safety of Ivarmacitinib in patients with moderate-to-severe atopic dermatitis and comorbid allergies () - Feb 21, 2025 - Abstract #AAD2025AAD_2931;
Ivarmacitinib demonstrates a good efficacy and safety profile in moderate-to-severe atopic dermatitis patients with prior systemic therapy. Ivarmacitinib demonstrates rapid and consistent efficacy and is well-tolerated in M-SAD patients with comorbid allergies.
- ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Early response to Ivarmacitinib and its impact on long-term efficacy in patients with moderate-to-severe atopic dermatitis: a post-hoc analysis of a phase III trial () - Feb 21, 2025 - Abstract #AAD2025AAD_2927;
P3
Ivarmacitinib demonstrates rapid and consistent efficacy and is well-tolerated in M-SAD patients with comorbid allergies. Early response to Ivarmacitinib at W4 yields better long-term efficacy in patients with moderate-to-severe AD.
- Zoryve (roflumilast cream) / Arcutis
Pooled Safety and Local Tolerability of Roflumilast Cream 0.15% From the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Trials of Patients With Atopic Dermatitis: Subgroup Analysis of Patients With Prior Inadequate Response, Intolerance, and/or Contraindications to Topical Treatments () - Feb 21, 2025 - Abstract #AAD2025AAD_2561;
P3
Roflumilast cream 0.15% was well tolerated in patients with AD, including those with prior TCS, TCI, and/or crisaborole failure. Sponsored by Arcutis Biotherapeutics, Inc.
- Zoryve foam (topical roflumilast foam) / Arcutis
Roflumilast Foam 0.3% in Patients With Scalp and Body Psoriasis: Improvements in Patient-Reported Outcomes () - Feb 21, 2025 - Abstract #AAD2025AAD_2559;
P3
Treatment with roflumilast foam 0.3% improved patient-reported outcomes and quality of life in patients with scalp and body psoriasis. Sponsored by Arcutis Biotherapeutics, Inc.
- ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
Efficacy and safety of ivarmacitinib, a selective Janus kinase 1 (JAK1) inhibitor, for the treatment of adult with severe alopecia areata (AA): a randomized, double-blind, placebo-controlled phase 3.. (Chapin Theater - Level III) - Feb 21, 2025 - Abstract #AAD2025AAD_2168;
- ||| Zoryve (roflumilast cream) / Arcutis
P3 data, Journal: Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2-5?Years With Mild-to-Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial. (Pubmed Central) - Feb 21, 2025
P3
Sponsored by Arcutis Biotherapeutics, Inc. In this Phase 3 trial, once-daily roflumilast cream 0.05% improved AD signs/symptoms in patients aged 2-5?years, with early pruritus improvement, low AE rates, and local tolerability comparable with vehicle.
- || Zoryve foam (topical roflumilast foam) / Arcutis, Daliresp (roflumilast) / AstraZeneca, isotretinoin / Generic mfg.
Review, Journal: Child and Adult Seborrheic Dermatitis: A Narrative Review of the Current Treatment Landscape. (Pubmed Central) - Feb 15, 2025
The treatment of SD requires an individualized approach, utilizing a range of topical, systemic, and procedural interventions. The advent of new treatments like roflumilast foam offers novel, well-tolerated, and safer options than what has been available in the past.
- | Daliresp (roflumilast) / AstraZeneca, Zoryve (roflumilast cream) / Arcutis
Journal: Neurodermatitis of the scalp associated with trichotillomania treated with roflumilast cream 0.3. (Pubmed Central) - Jan 27, 2025
The advent of new treatments like roflumilast foam offers novel, well-tolerated, and safer options than what has been available in the past. No abstract available
- |||| New P2 trial: A Trial of SHR0302Base in Patients With Vitiligo (clinicaltrials.gov) - Jan 24, 2025
P2, N=152, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
- ||| Zoryve (roflumilast cream) / Arcutis
P3 data, Journal: Long-Term Safety and Efficacy with Roflumilast Cream 0.15% in Patients Aged ?6 Years with Atopic Dermatitis: A Phase 3 Open-Label Extension Trial. (Pubmed Central) - Jan 12, 2025
P3
Roflumilast cream 0.15% was well tolerated for up to 56 weeks. BIW application to normal-appearing flare-prone sites maintained improvement in AD signs and symptoms, showing that proactive treatment represents an alternative to the current standard practice of reactive treatment.
- |||||| Zoryve (roflumilast cream) / Arcutis
Enrollment open, Enrollment change: Efficacy and Safety of Roflumilast Cream in Subjects with Atopic Dermatitis (clinicaltrials.gov) - Dec 20, 2024
P3, N=351, Recruiting, Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
BIW application to normal-appearing flare-prone sites maintained improvement in AD signs and symptoms, showing that proactive treatment represents an alternative to the current standard practice of reactive treatment. Not yet recruiting --> Recruiting | N=210 --> 351
- |||| Zoryve (roflumilast cream) / Arcutis
Enrollment open: HDM3014-301: Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study (clinicaltrials.gov) - Dec 13, 2024
P3, N=189, Recruiting, Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Not yet recruiting --> Recruiting | N=210 --> 351 Not yet recruiting --> Recruiting
- | AiSuDa (ivarmacitinib) / Jiangsu Hengrui Pharma, Arcutis
New P2 trial: JAK1 Inhibitor Ivarmacitinib Reversing Immunotherapy Resistance in TNBC (clinicaltrials.gov) - Dec 12, 2024
P2, N=40, Not yet recruiting, Sponsor: Fudan University
- ||| ivarmacitinib (SHR0302) / Jiangsu Hengrui Pharma, Arcutis
P3 data, Journal: Ivarmacitinib, a selective Janus kinase 1 inhibitor, in patients with moderate-to-severe active rheumatoid arthritis and inadequate response to conventional synthetic DMARDs: results from a phase III randomised clinical trial. (Pubmed Central) - Nov 28, 2024
P3
Not yet recruiting --> Recruiting Ivarmacitinib may offer a potential therapeutic option for patients with RA who have an inadequate response to csDMARDs, with a safety profile that was generally manageable over 1 year of treatment and similar to other JAK inhibitors.
- || Zoryve (roflumilast cream) / Arcutis
Clinical, Journal: Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. (Pubmed Central) - Nov 20, 2024
P3
In 2 phase 3 trials enrolling adults and children, once-daily roflumilast cream, 0.15%, improved AD relative to vehicle cream, based on multiple efficacy end points, with favorable safety and tolerability. ClinicalTrials.gov Identifiers: NCT04773587, NCT04773600.
- | AiSuDa (ivarmacitinib) / Jiangsu Hengrui Pharma, Arcutis
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: SHR0302 and Steroid As First Line Therapy for Chronic GVHD (clinicaltrials.gov) - Nov 13, 2024
P1, N=28, Completed, Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifiers: NCT04773587, NCT04773600. Recruiting --> Completed | N=73 --> 28 | Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2024 --> Sep 2024