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TYK2/JAK1 Inhibitor

Brepocitinib for Dermatomyositis (VALOR Trial)

Phase 3
Recruiting
Research Sponsored by Priovant Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
Adult subjects (18-75 years old)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

VALOR Trial Summary

This trial is testing a new drug to treat dermatomyositis. The goal is to see if it is better than placebo at reducing symptoms.

Who is the study for?
Adults aged 18-75 with dermatomyositis, weighing between 40-130 kg and a BMI under 40. Participants must have active muscle and skin disease, may be on or have had corticosteroids or immunosuppressants, and meet specific diagnostic criteria. Excluded are those with recent cancers (with some exceptions), high thrombosis risk, severe infections, irreversible muscle damage from the disease, end-stage organ involvement, certain other diseases or conditions.Check my eligibility
What is being tested?
The trial is testing Brepocitinib's effectiveness compared to a placebo in adults with dermatomyositis over a year. It measures improvement using the Total Improvement Score. After this phase, participants can join an open-label extension for another year where everyone receives Brepocitinib.See study design
What are the potential side effects?
As Brepocitinib is a TYK2/JAK1 inhibitor that affects immune function, potential side effects could include increased risk of infections, changes in blood counts leading to anemia or clotting issues; liver enzyme alterations; cholesterol level changes; headache; respiratory tract infections; nausea.

VALOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with dermatomyositis.
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I am between 18 and 75 years old.
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I have ongoing muscle and skin conditions.
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I am currently on or have been treated with steroids, hydroxychloroquine, or one non-steroid immunosuppressant.
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My weight is between 40kg and 130kg, and my BMI is less than 40.

VALOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Improvement Score (TIS) at Week 52
Secondary outcome measures
Change from baseline in HAQ Disability Index score at Week 52
Cutaneous Dermatomyositis Area and Severity Index (CDASI) Activity Score after 52 weeks of brepocitinib administration QD, in comparison to placebo
Normalized change from baseline area under the concentration-time curve (AUC) in oral prednisone-equivalent dose through Week 52
+1 more

VALOR Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Brepocitinib Dose Level 2 PO QDExperimental Treatment1 Intervention
Group II: Brepocitinib Dose Level 1 PO QDExperimental Treatment1 Intervention
Group III: Placebo PO QDPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Priovant Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
26 Total Patients Enrolled
Christina Crater, MDStudy DirectorSenior Director, Clinical Development
Noriko Iikuni, MDStudy DirectorVP, Clinical Development

Media Library

Brepocitinib (TYK2/JAK1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05437263 — Phase 3
Dermatomyositis Research Study Groups: Brepocitinib Dose Level 2 PO QD, Brepocitinib Dose Level 1 PO QD, Placebo PO QD
Dermatomyositis Clinical Trial 2023: Brepocitinib Highlights & Side Effects. Trial Name: NCT05437263 — Phase 3
Brepocitinib (TYK2/JAK1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05437263 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project only consider elderly patients?

"The age limit for this clinical trial is set at 74 years old. All participants must also be of legal age, which is 18 years old in most jurisdictions."

Answered by AI

How many individuals are taking part in this clinical trial?

"In order for this clinical trial to move forward, we need 225 willing and eligible individuals. The locations where patients can participate in the study include University of Florida Health - Springhill in Gainesville, Florida and University of California - Irvine in Dallas, California."

Answered by AI

Are there any patients needed for this clinical research at the moment?

"That is correct. As of today, the clinical trial indicated on clinicaltrials.gov is still recruiting patients. The study was originally posted on October 31st, 2020 and was last updated November 4th, 2020. Currently, the goal is to enroll 225 patients from 20 different sites."

Answered by AI

To whom does this study open enrollment?

"This study is looking for adult patients (18-74 years old) that have been diagnosed with dermatomyositis according to the 2017 EULAR/ACR Classification Criteria. The 225 participants must also exhibit active muscle and skin disease, have prior or current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant, weigh more than 40 kg but less than 130 kg, and have a body mass index (BMI) that is below 40 kg/m2."

Answered by AI

At how many facilities is this research being conducted?

"20 different medical centres are currently recruiting patients for this clinical trial. If you live near any of the following locations - Gainesville, Dallas and Orlando - to name a few, please consider enrolling as it will minimize travel requirements."

Answered by AI

Could you elaborate on the side effects of Brepocitinib?

"Brepocitinib's safety is rated highly by our team because it has received a score of 3. This number reflects that the drug is currently in Phase 3 testing, meaning that there is both evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Trial Site
What portion of applicants met pre-screening criteria?
Met criteria

What questions have other patients asked about this trial?

How many in-person visits? Can any of these be completed through telehealth? Isn’t this a “free” trial-you asked for insurance info. I want the trial to be approved by my doctors I have many medical conditions and do not want anything to interfere with those. Is this a paid trial?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Completed on previous form X 2.
PatientReceived 2+ prior treatments
~72 spots leftby Dec 2024