History of Changes for Study: NCT05437263

A Phase 3 Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis (VALOR)

Latest version (submitted April 4, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	June 24, 2022	None (earliest Version on record)
2	August 31, 2022	Contacts/Locations, Outcome Measures, Study Status, References, Eligibility and Study Identification
3	September 28, 2022	Study Status and Contacts/Locations
4	October 31, 2022	Study Status and Contacts/Locations
5	October 31, 2022	Contacts/Locations and Study Status
6	November 4, 2022	Study Status and Contacts/Locations
7	November 30, 2022	Contacts/Locations and Study Status
8	December 30, 2022	Outcome Measures, Eligibility, Study Status, Contacts/Locations and Study Description
9	January 31, 2023	Study Status and Contacts/Locations
10	February 28, 2023	Study Status and Contacts/Locations
11	March 31, 2023	Contacts/Locations and Study Status
12	April 28, 2023	Study Status and Contacts/Locations
13	May 31, 2023	Study Status and Contacts/Locations
14	June 30, 2023	Study Status and Contacts/Locations
15	July 31, 2023	Outcome Measures, Study Status, Contacts/Locations and Eligibility
16	August 1, 2023	Study Status and Outcome Measures
17	August 31, 2023	Contacts/Locations and Study Status
18	September 29, 2023	Contacts/Locations and Study Status
19	November 1, 2023	Contacts/Locations and Study Status
20	December 1, 2023	Contacts/Locations and Study Status
21	January 9, 2024	Study Status and Contacts/Locations
22	January 31, 2024	Contacts/Locations and Study Status
23	March 4, 2024	Study Status and Contacts/Locations
24	April 4, 2024	Eligibility, Outcome Measures and Study Status

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Study NCT05437263
Submitted Date: June 24, 2022 (v1)

Study Identification


Unique Protocol ID:	PVT-2201-301
Brief Title:	A Phase 3 Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis (VALOR)
Official Title:	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis
Secondary IDs:	2022-500367-12-00 [Registry Identifier: EU CT Number]

Study Status


Record Verification:	June 2022
Overall Status:	Recruiting
Study Start:	July 2022
Primary Completion:	December 2024 [Anticipated]
Study Completion:	December 2024 [Anticipated]

First Submitted:	June 24, 2022
First Submitted that Met QC Criteria:	June 24, 2022
First Posted:	June 29, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	June 24, 2022
Last Update Posted:	June 29, 2022 [Actual]

Study Description


Brief Summary:	This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS).
Detailed Description:

Conditions


Conditions:	Dermatomyositis
Keywords:	brepocitinib dermatomyositis TYK2/JAK1 inhibitor PF-06700841 PVT-2201

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	225 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Brepocitinib Dose Level 1 PO QD	Drug: Brepocitinib Oral Brepocitinib
Experimental: Brepocitinib Dose Level 2 PO QD	Drug: Brepocitinib Oral Brepocitinib
Placebo Comparator: Placebo PO QD	Drug: Placebo Oral Placebo

Outcome Measures


Primary Outcome Measures:
1.	Total Improvement Score (TIS) at Week 52 [ Time Frame: 52 weeks ] TIS is a composite endpoint based on improvement in the 6 Disease Activity Core Set Measure (CSM) scores and ranges from 0 to 100 (2016 European League Against Rheumatism [EULAR]/American College of Rheumatology [ACR] Myositis Response Criteria)
Secondary Outcome Measures:
1.	TIS responder rate after 52 weeks of brepocitinib administration QD, in comparison to placebo [ Time Frame: 52 weeks ] Proportion of responders, defined as achieving TIS ≥ 40 points (moderate improvement) at Week 52
2.	Time to use of rescue medication through 52 weeks of brepocitinib administration QD, in comparison to placebo [ Time Frame: 52 weeks ] Time to use of rescue medication through Week 52
3.	MMT-8 after 52 weeks of brepocitinib administration QD, in comparison to placebo [ Time Frame: 52 weeks ] Change from baseline in MMT-8 score at Week 52

Eligibility


Minimum Age:	18 Years
Maximum Age:	74 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies Adult subjects (18-74 years old) Active muscle and skin disease at screening and baseline Current therapy with corticosteroids, hydroxychloroquine, and/or one non-steroid immunosuppressant Weight > 40 kg to < 130 kg, and with a body mass index (BMI) < 40 kg/m2. Exclusion Criteria: Dermatomyositis with end-stage organ involvement Dermatomyositis with irreversible muscle involvement History of: Any lymphoproliferative disorder Active malignancy; History of cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.) Cancer-associated dermatomyositis Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome) Participants at a risk of thrombosis and cardiovascular disease Participants with a high risk for herpes zoster reactivation Participants with active or recent infections

Contacts/Locations


Central Contact Person:	Clinical Trial Administrator Telephone: (646) 402-6892 Email: ValorStudyManager@PriovantTx.com
Study Officials:	Christina Crater, MD Study Director Senior Director, Clinical Development
Locations:	United States, Florida
	HMD Research LLC [Recruiting] Orlando, Florida, United States, 32819
	Integral Rheumatology & Immunology Specialists (IRIS) [Not yet recruiting] Plantation, Florida, United States, 33324

IPDSharing


Plan to Share IPD:	Yes Priovant Therapeutics will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) from eligible studies upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Data requests will be reviewed and approved on the basis of scientific merit.
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR)
	Time Frame: The data will be made available within 24 months after study completion and will be accessible for a time frame appropriate for the approved proposal.
	Access Criteria: Access will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA). Further details on Priovant Therapeutics' data sharing criteria and process for requesting access can be obtained by emailing info@priovanttx.com.
	URL:

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