A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Lichen Planopilaris

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with lichen planopilaris

Start Date19 Mar 2026

Sponsor / Collaborator

Priovant Therapeutics, Inc.

NCT06978725

/ RecruitingPhase 2/3

A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Cutaneous Sarcoidosis

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.

Start Date09 Apr 2025

Sponsor / Collaborator

Priovant Therapeutics, Inc.

NCT06431373

/ Active, not recruitingPhase 3

A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis

The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).

Start Date11 Sep 2024

Sponsor / Collaborator

Priovant Therapeutics, Inc.

100 Clinical Results associated with Brepocitinib

100 Translational Medicine associated with Brepocitinib

100 Patents (Medical) associated with Brepocitinib

Literatures (Medical) associated with Brepocitinib

01 Oct 2026·JAMA Dermatology

Skin-Specific Outcomes of Brepocitinib in Patients With Dermatomyositis

Article

Author: Pearson, David ; Castillo, Rochelle ; Culton, Donna ; Schadt, Courtney ; Vleugels, Ruth Ann ; LaChance, Avery ; Elman, Scott ; Haemel, Anna ; Rambhatla, Pranita V. ; Flowers, R. Hal ; Crew, Ashley ; Shahriari, Neda ; Lam, Christina ; Callen, Jeffrey ; Fivenson, David ; Fiorentino, David ; Graham, Lauren ; Taylor, Dustin ; Werth, Victoria P. ; Hashemi, Kimberly ; Fernandez, Anthony P. ; Maderal, Andrea ; Hurabielle, Charlotte ; Subhadarshani, Sweta ; Boh, Erin ; Sluzevich, Jason ; Min, Michelle S. ; Paravar, Taraneh ; Femia, Alisa ; Onajin, Oluwakemi ; Shaw, Katharina S. ; Cascino, Matthew D. ; Rashighi, Mehdi ; Mangold, Aaron R. ; Chong, Benjamin

Importance:

Brepocitinib, a first-in-class oral, selective TYK2 and JAK1 inhibitor, demonstrated broad efficacy in a phase 3 randomized clinical trial in dermatomyositis.

Objective:

To evaluate the effects of brepocitinib on cutaneous disease activity, itch, skin-related quality of life (QOL), and achievement of remission-level end points in adults with dermatomyositis over 52 weeks of treatment.

Design, Setting, and Participants:

This prespecified secondary analysis of the 52-week, phase 3, double-blind, placebo-controlled, randomized VALOR clinical trial, conducted from October 2022 to July 2025 at 90 sites in 20 countries, included adults with dermatomyositis and active skin and muscle disease.

Intervention:

Once-daily brepocitinib, 30 mg; brepocitinib, 15 mg; or placebo.

Main Outcomes and Measures:

Key secondary outcomes in VALOR included change in the Cutaneous Dermatomyositis Disease Area and Severity Index–Activity (CDASI-A) score and achievement of clinically meaningful CDASI-A response (≥40% relative and ≥4-point absolute improvement). Exploratory outcomes included itch (Peak Pruritus Numeric Rating Scale [PP-NRS]); skin-related QOL (Skindex-16); achievement of Cutaneous Dermatomyositis Activity–Investigator’s Global Assessment (CDA-IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement; and functional skin remission (CDASI-A ≤5). Between-group differences were analyzed using ANCOVA or Cochran-Mantel-Haenszel methods.

Results:

The VALOR trial enrolled 241 participants (mean [SD] age, 50.6 [13.3] years; 187 [77.6%] female; 54 [22.4%] male). Beginning at week 4, brepocitinib, 30 mg, demonstrated superiority over placebo in mean (SD) change from baseline in CDASI-A score (−6.4 [5.8] vs −3.5 [6.0], respectively; difference, −3.0; 95% CI, −4.6 to −1.4; P &lt; .001) and resulted in greater achievement of clinically meaningful CDASI-A response (27 participants [33.3%] vs 14 participants [17.7%], respectively; difference, 15.1 percentage points [pp]; 95% CI, 1.7-28.6 pp), itch remission (PP-NRS ≤1: 31 participants [38.3%] vs 15 participants [19.0%], respectively; difference, 18.9 pp; 95% CI, 5.0-32.9 pp) and improvement in skin-related QOL (Skindex-16 score: −12.9 [21.6] vs −0.9 [22.4], respectively; difference, −11.9; 95% CI, −17.9 to −6.0). Benefits on these measures were observed at all time points from week 4 through week 52. Among the 155 participants (64.3%) with moderate to severe skin disease at baseline, brepocitinib, 30 mg, was also associated with higher rates of achievement of a CDA-IGA score of clear or almost clear compared with placebo (21 participants [45.7%] vs 12 participants [21.8%], respectively; difference, 21.1 pp at week 52; 95% CI, 2.5-39.7 pp) and functional skin remission (20 participants [43.5%] vs 11 participants [20.8%], respectively; difference at week 52, 26.6 pp; 95% CI, 7.6-45.5 pp). Brepocitinib exhibited a safety profile consistent with approved JAK and TYK2 inhibitors.

Conclusions and Relevance:

In this secondary analysis of a randomized clinical trial in dermatomyositis, once-daily brepocitinib, 30 mg, resulted in rapid, durable, and remission-level control of skin disease with an acceptable safety profile.

Trial Registration:

ClinicalTrials.gov Identifier: NCT05437263

01 Oct 2026·EUROPEAN JOURNAL OF DERMATOLOGY

Journal Club: Brepocitinib in dermatology - from mechanistic rationale to emerging clinical evidence in dermatomyositis and other skin and hair diseases

Article

Author: Jiménez-Briones, Luis ; Goller, Simon ; Ferreira, César ; González, Jorge Martín-Nieto ; Piqueras, Paloma Garcia ; Sánchez, Belén Rodríguez

02 Sep 2026·EXPERT OPINION ON BIOLOGICAL THERAPY

Transforming the treatment of autoimmune skin diseases: a journey through biologic therapies

Review

Author: Celin, Giulia ; Ciolfi, Christian ; Alaibac, Mauro ; Tartaglia, Jacopo

INTRODUCTION:

Autoimmune blistering diseases and autoimmune connective tissue diseases with prominent skin involvement are increasingly managed with biologic and targeted therapies. We review the evidence supporting these approaches and their practical positioning.

AREAS COVERED:

We performed a PubMed/MEDLINE literature review (inception to February 2026) on biologic therapies for pemphigus, pemphigoid spectrum disorders, LABD, EBA, cutaneous lupus erythematosus, and dermatomyositis, including selected non-biologic small molecules, focusing on validated cutaneous outcomes. Evidence is strongest for B-cell depletion in pemphigus (including dose-optimization strategies) and for IL-4/IL-13 pathway blockade in BP, with additional data for anti-IgE therapy in selected BP phenotypes. In CLE, the most consistent cutaneous datasets involve pDC/type I interferon-axis modulation and BAFF inhibition, largely derived from systemic lupus cohorts; TYK2 inhibition has shown controlled benefit in CLE. In dermatomyositis, CDASI-based evidence is strongest for IVIg, with anti-IFNβ therapy and the TYK2/JAK1 inhibitor brepocitinib (positive in a phase 3 trial) showing cutaneous benefit; other biologics show limited trial signals.

EXPERT OPINION:

Biologic/targeted therapies should be positioned by disease phenotype and evidence strength, prioritizing steroid-sparing strategies in pemphigus and BP and using CLASI/CDASI-anchored outcomes to interpret lupus and dermatomyositis data. Evidence for rare AIBDs remains mostly case-level and should be framed accordingly.

143

News (Medical) associated with Brepocitinib

29 Oct 2026

·www.biospace.com

Roivant and Priovant Announce Positive Results in CLARITY-1 and CLARITY-2 Phase 3 Trials for Brepocitinib in Non-Infectious Uveitis (NIU)

Brepocitinib 45 mg once-daily achieved statistically significant benefit compared to placebo on the primary and all key secondary endpoints for each of CLARITY-1 and CLARITY-2, the two identical Phase 3 trials comprising the CLARITY program in NIU Median time to treatment failure for brepocitinib patients was greater than 48 weeks in both studies, compared with ~12 weeks on placebo in each study (p 5 at Baseline 39.4% 8.6% Δ 31.3%; P<0.0001 54.9% 7.2% Δ 49.8%; P<0.0001 Resolution of Macular Edema at Week 48 Among Eyes with Macular Edema at Baseline 40.4% 2.1% Δ 33.3%; P=0.0041 42.6% 7.0% Δ 40.1%; P=0.0002 Achievement of ≥ 5-point Improvement in NEI VFQ-25 Overall Composite Score from Baseline at Week 48, Among Subjects with Baseline ≤ 95 36.4% 13.7% Δ 21.9%; P=0.0013 40.4% 14.1% Δ 24.5%; P=0.0003 * Deltas account for covariates Efficacy analyses exclude one subject who was randomized but did not receive any doses of masked study drug. Safety and Regulatory Submissions Brepocitinib was generally well tolerated during the treatment period. Most events were mild or moderate in severity, and only 3% of participants discontinued treatment due to an AE. The observed safety pro the trials was consistent with the known safety pro brepocitinib, with no new safety signals observed. Priovant intends to supplemental New Drug Application (sNDA) for brepocitinib for treatment of NIU in the first half of calendar year 2027. “The breadth and magnitude of benefit seen in the CLARITY studies position brepocitinib to potentially set a new standard for the treatment of non-infectious uveitis,” said Ben Zimmer, CEO of Priovant. “With LISRAYA now commercially available for adults with dermatomyositis, we see NIU as the potential next pillar of a leading rare disease immunology franchise. I would like to thank all of the investigators and patients who participated in the CLARITY trials, without whom this moment would not be possible.” Investor Conference Call Information Roivant will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, October 21, 2026, to discuss the Phase 3 results for brepocitinib in non-infectious uveitis. To access the conference call by phone, please register online using this registration link . The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at The archived webcast will be available on Roivant’s website after the conference call. Roivant will also host an investor day on Wednesday, December 9, 2026. To attend the event in person or by webcast, please register online using this registration link . About Priovant Priovant Therapeutics is a biotechnology company dedicated to developing and commercializing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company’s commercial product, LISRAYA™ (brepocitinib) is the first and only targeted oral therapy approved for the treatment of adults with dermatomyositis. See important LISRAYA safety information, including boxed warning, at lisrayahcp.com/pi. Brepocitinib, a first-in-class TYK2/JAK1 inhibitor, also recently generated positive Phase 3 data in non-infectious uveitis (NIU). Brepocitinib is under evaluation in a Phase 3 program in cutaneous sarcoidosis, and a Phase 2b/3 program in lichen planopilaris. These potential indications have not been approved by the FDA. Priovant Therapeutics is a Roivant (Nasdaq: ROIV) company. About Roivant Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit . Roivant Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product and product candidates, the availability and success of topline results from our ongoing clinical trials, the timing of potential regulatory approvals for our product and product candidates, any commercial potential of our product and product candidates following applicable regulatory approvals and the outcome of any pending litigation. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: Investors Keyur Parekh keyur.parekh@roivant.com Media Stephanie Lee stephanie.lee@roivant.com A photo accompanying this announcement is available at

Phase 3Clinical ResultDrug Approval

22 Oct 2026

·www.fiercepharma.com

Roivant comes for Humira as Lisraya checks boxes in inflammatory eye disease phase 3s

With the ink barely dry on Lisraya’s first approval, Roivant and its spinout Priovant are wasting little time in arguing for the dual TYK2/JAK1 inhibitor to inherit a larger immune-mediated kingdom. This week, the companies announced wins across their late-stage Clarity-1 and Clarity-2 studies of once-daily brepocitinib in noninfectious uveitis (NIU), a form of eye inflammation that is one of the leading causes of blindness among working-age people. Wins in hand, Roivant said Wednesday that Priovant plans to submit the data to the FDA in the first half of 2027, contending that the “magnitude and breadth” of benefit observed in the studies could give brepocitinib the “potential to be the most effective systemic, non-steroid treatment option for NIU.” Corticosteroids aside, and apart from off-label use of other biologics, AbbVie’s Humira currently stands alone as the only systemic biologic treatment with an FDA approval specifically for NIU. Now jockeying for that niche, an NIU green light would mark the second indication for brepocitinib, which was approved in late August as Lisraya for dermatomyositis (DM), an autoimmune condition characterized by progressive muscle weakness and extensive, painful and itchy skin lesions. Clarity-1 and Clarity-2 ran as identical studies, enrolling 371 patients in total and setting time to treatment failure from week six through week 48 as the primary endpoint. All told, Roivant and Priovant’s drug showed consistent benefits in preventing treatment failure versus placebo, even across multiple patient subgroups. In Clarity-1, brepocitinib was tied to a 35.4% cumulative incidence of treatment failure at week 48, compared with a rate of 78.7% among patients on placebo. In Clarity-2, assessing the same 45-mg dose, Roivant’s medicine was linked to a 32.4% treatment failure incidence versus 77.8% in the control group. Meanwhile, pooled data from the pair of studies found that 62% of patients on brepocitinib achieved steroid-free disease control at week 48, compared with 20% of participants on placebo. And among patients who entered the studies with macular edema, 42% of eyes in the brepocitinib group showed resolution of the condition by week 48, again in pooled results, versus just 4.8% in the placebo group. In framing that readout, analysts at Jefferies noted Wednesday that macular edema is “what’s driving the blindness” in NIU patients. The analyst shop said it was also impressed by the consistency of response seen with brepocitinib, its ability to stabilize NIU and the fact that “patients are coming off steroids while achieving all these benefits.” If undertreated, NIU can cause permanent vision loss. Beyond that risk, the condition is often associated with eye pain, floaters and visual impairment of multiple types, including visual acuity, peripheral vision, color recognition and the ability to focus on moving objects, Roivant said. The condition is estimated to affect 70,000 to 190,000 adults in the United States. Analysts have already pinned blockbuster sales expectations on Lisraya, with Roivant noting in an investor presentation (PDF) Wednesday that it views the opportunity in NIU as comparable in size to its initial indication in DM. In its Wednesday note to clients, Jefferies said that each indication Roivant is pursuing for Lisraya could represent an “at least” $1 billion to $3 billion peak sales opportunity, adding that it’s “easy to figure out brepo could ultimately be at least $10B peak sales in the US.” Meanwhile, given that Roivant’s data looked good in both patients with and without prior exposure to tumor necrosis factor (TNF) inhibitors, the class to which Humira belongs, the analysts surmised that the Clarity data “indeed looks very strong on an apples-to-apples basis.” The Jefferies team said it currently expects that payers would require NIU patients to “step through” Humira, which has biosimilar options available, before moving to an approved Lisraya for the disease. However, the analysts cautioned that the projection could be “conservative given how strong the data were today.” More broadly, Roivant has framed its development efforts for Lisraya as a “multi-indication journey” and is already mapping out the path to two additional potential uses in cutaneous sarcoidosis and lichen planopilaris beyond DM and NIU. Across the four indications, Roivant has projected a potential patient pool for Lisraya of around 280,000 people.

22 Oct 2026

·www.biospace.com

Roivant’s TYK2/JAK inhibitor reduces need for steroids in inflammatory eye disease

Taylor Tieden for BioSpace Brepocitinib is on a roll. After winning approval for an autoimmune skin disease, Roivant Sciences subsidiary Priovant’s drug hit all primary and secondary endpoints in a pair of Phase 3 non-infectious uveitis trials, leading analysts to say the candidate “looked superior to Humira.” Roivant Sciences and subsidiary Priovant’s TYK2/JAK inhibitor brepocitinib—recently approved for an autoimmune skin disease—significantly reduced the need for steroid treatment in patients with non-infectious uveitis in a pair of Phase 3 studies. The results are a “clean win . . . with much better efficacy than AbbVie’s Humira,” currently the only approved non-steroid treatment for non-infectious uveitis (NIU), Leerink Partners said in a Wednesday afternoon note. Caused by viral, bacterial, fungal or parasitic infection of the uveal tract, NIU can cause pain, redness, photophobia and blindness. Roivant, which hunts and acquires existing assets to develop on its own, licensed brepocitinib from Pfizer in a joint deal that spun off Priovant in 2022. Priovant gained approval in August for brepocitinib—to be marketed as Lisraya—to treat the autoimmune skin disease dermatomyositis, and the company is now seeking the regulatory go-ahead in NIU based on two identical Phase 3 clinical trials called Clarity-1 and Clarity-2. Approvals Priovant nabs first FDA approval for targeted tablet in dermatomyositis Lisraya carries a boxed warning typical of JAK inhibitors, but otherwise has a broad label that allows use in all adults with the rare autoimmune disease, setting up the drug for blockbuster status in a few years, according to Leerink. August 28, 2026 · 2 min read · Tristan Manalac Read more Patients taking brepocitinib in both studies went more than 48 weeks before treatment failure—which captures tolerability and efficacy by measuring the time it takes for patients to stop taking the drug for any reason—compared with just 12 weeks for patients on placebo, meeting the trials’ primary endpoints, Roivant reported on Wednesday. Patients in the treatment arm went 40 weeks without requiring steroids, which set a “new bar” for noninfectious uveitis therapies, according to the company. Pooled analysis across the Clarity program saw 62% of patients on brepocitinib remain steroid-free at 48 weeks, compared to 20% on placebo. Leerink noted that 50% of patients fail on Humira within six months. Although the studies did not pit the two drugs against one another, the analysts said that brepocitinib “looked superior to Humira on a cross-trial basis with a much more aggressive steroid tapering schedule.” Brepocitinib’s effectiveness spanned a number of different patient subgroups, including those with or without experience taking a tumor necrosis factor (TNF) inhibitor such as Humira and those with forms of uveitis including idiopathic disease, the sight-threatening visual condition birdshot chorioretinopathy and the inflammatory disease sarcoidosis. Brepocitinib also met all of the trials’ secondary endpoints, including measurements of sustained steroid-free disease inactivity, chorioretinal vascular leakage—or the abnormal escape of fluid and plasma from blood vessels into the retina— and patient-reported visual aptitude. The drug candidate also resolved macular edema in 42% of eyes in patients who the condition in addition to uveitis, compared with just 4.8% on placebo. Only 3% of participants discontinued brepocitinib because of an adverse event, most of which were mild or moderate, according to the company. “The breadth and magnitude of benefit seen in the Clarity studies position brepocitinib to potentially set a new standard for the treatment of non-infectious uveitis,” Priovant CEO Ben Zimmer said in a prepared statement. “With Lisraya now commercially available for adults with dermatomyositis, we see NIU as the potential next pillar of a leading rare disease immunology franchise.” Priovant plans to supplemental application for the drug in NIU in the first half of 2027. Leerink analysts said Roivant management is exploring a first-line approach for brepocitinib in NIU, particularly as the studies showed largely consistent benefit in patients who had previously taken a TNF inhibitor and those in the overall treatment population. The analysts have projected sales of $54 million for Lisraya in dermatomyositis, and $559 million in fiscal year 2028. For non-infectious uveitis, the analysts modeled $2.3 billion in unadjusted sales by the end of 2029, skewing higher if the drug receives a label friendly to patients who have not taken a TNF inhibitor like Humira. Brepocitinib is one leg of a “three-legged stool,” making up the clinical and commercial prospects at the hub-and-spoke pharma conglomerate, Roivant CEO Matt Gline told BioSpace earlier this month. The other two legs are the pulmonary hypertension candidate mosliciguat, which is currently in a late-stage study after succeeding in Phase 2, and a mid- to late-stage anti-inflammatory drug candidate called IMVT-1402. Gline told BioSpace prior to the readout that he expected the NIU readout to give brepocitinib “another brick to build a big wall.” Pipeline Roivant, the ‘inveterate drug hunters’, enters commercial era with Lisraya CEO Matt Gline is juggling Roivant Sciences’ first solo drug launch and several maturing programs as the hub-and-spoke company sets its sights on a massive turning point into commercial viability. October 5, 2026 · 6 min read · Michael Gibney Read more

Clinical ResultPhase 3Drug ApprovalPhase 2License out/in

100 Deals associated with Brepocitinib

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KEGG	Wiki	ATC	Drug Bank
D11537	-	-	DB15003

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dermatomyositis	United States	Priovant Therapeutics, Inc.	27 Aug 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sarcoidosis	NDA/BLA	United States	Roivant Sciences Ltd.	06 Feb 2026
Lichen Planus Follicularis	Phase 3	United States	Priovant Therapeutics, Inc.	19 Mar 2026
Lichen Planus Follicularis	Phase 3	Australia	Priovant Therapeutics, Inc.	19 Mar 2026
Lichen Planus Follicularis	Phase 3	Canada	Priovant Therapeutics, Inc.	19 Mar 2026
Lichen Planus Follicularis	Phase 3	United Kingdom	Priovant Therapeutics, Inc.	19 Mar 2026
Non-infectious posterior uveitis	Phase 3	United States	Priovant Therapeutics, Inc.	11 Sep 2024
Non-infectious posterior uveitis	Phase 3	Argentina	Priovant Therapeutics, Inc.	11 Sep 2024
Non-infectious posterior uveitis	Phase 3	Australia	Priovant Therapeutics, Inc.	11 Sep 2024
Non-infectious posterior uveitis	Phase 3	Austria	Priovant Therapeutics, Inc.	11 Sep 2024
Non-infectious posterior uveitis	Phase 3	Belgium	Priovant Therapeutics, Inc.	11 Sep 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05437263 (VALOR, ACR2026)	Phase 3	Dermatomyositis	241	Brepocitinib 30 mg	repukoxntl(ihjkxllgos): Difference = -3.0, P-Value = < 0.001 View more	Positive	06 Nov 2026
				Placebo
NCT05437263 (VALOR, ACR2026)	Phase 3	Dermatomyositis	241	Brepocitinib 30 mg	fgrfvetzgk(pdcrnkwisy) = lyiffobhxt rcetwernil (pbnfipvszn ) View more	Positive	06 Nov 2026
				Placebo	fgrfvetzgk(pdcrnkwisy) = ppzizhctke rcetwernil (pbnfipvszn ) View more
NCT05437263 (VALOR, ACR2026)	Phase 3	Dermatomyositis	241	Brepocitinib 15 mg	yykotyttul(ocdpnyxhbi) = Improvements in EMGA Lung-VAS were observed (Figure 3) ibynvmeljb (reswqxtzpd ) View more	Positive	06 Nov 2026
NCT06978725 (BEACON, ACR2026)	Phase 2	Sarcoidosis	31	Brepocitinib 45 mg	tfukjqykxp(fstyshvrez) = cnnvhjvohy vusjvwkscs (pwwoqzmknk ) View more	Positive	06 Nov 2026
				Placebo	sbhacdmmlx(oltpoanpno) = lywguaxbat jcbkgrlkuu (ssoqokvkxh )
VALOR (ACR2026)	Phase 3	Dermatomyositis	241	Brepocitinib 30 mg	cgijkwqgwn(yrkamdfnfg) = eqtjdvmgfm ucslwzcmis (gzqivmovby ) View more	Positive	06 Nov 2026
				Placebo	cgijkwqgwn(yrkamdfnfg) = fhcydsbhiz ucslwzcmis (gzqivmovby ) View more
NCT05437263 (VALOR, Pubmed \| JAMA Dermatol)	Phase 3	Dermatomyositis	241	Brepocitinib 30 mg	mkxniponaa(iwnraqzvdn) = sgdaagmfwp kjnzttezdh (nqsrgtjwmy ) View more	Positive	01 Oct 2026
				Placebo	mkxniponaa(iwnraqzvdn) = iutvftinwn kjnzttezdh (nqsrgtjwmy ) View more
VALOR (EULAR2026)	Phase 3	Dermatomyositis	241	Brepocitinib 30 mg	cokrfvmhuz(wefldvjnnp) = hnadsdqemb aehqztsinz (jgwupapdop ) View more	Positive	11 Jun 2026
				Placebo	cokrfvmhuz(wefldvjnnp) = hgxrfmypql aehqztsinz (jgwupapdop ) View more
NCT05437263 (VALOR, EULAR2026)	Phase 3	Dermatomyositis	241	Brepocitinib 30 mg	durogzpsjy(pgwhhjylfi) = qhbvjnhyuo qbwkwpjmle (sttwsankhu ) View more	Positive	11 Jun 2026
				Placebo	cgeabtourk(agzwxvposm) = ngwcfhoiqo nklrpuclgf (cnfhtcamcl ) View more
NCT05437263 (Pubmed \| N Engl J Med)	Phase 3	Dermatomyositis	241	Brepocitinib 30 mg	crrnagridt(lajmmmpzyg) = ahasmqhbke wwmcdkihpj (ubrgtexkyp ) View more	Positive	14 May 2026
				Brepocitinib 15 mg	crrnagridt(lajmmmpzyg) = wmlkjbdohe wwmcdkihpj (ubrgtexkyp )
NCT05437263 (N Engl J Med \| GlobeNewswire) Manual	Phase 3	Dermatomyositis	241	brepocitinib 30 mg	slzuvbkmyq(gmravpqqzf) = udsjrazlsx krlgwboioj (rvcpfpyrrf ) Met View more	Positive	28 Mar 2026
				brepocitinib 15 mg	slzuvbkmyq(gmravpqqzf) = wdgnahudvd krlgwboioj (rvcpfpyrrf ) Met

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