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

Primary Purpose

Dermatomyositis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brepocitinib
Placebo
Sponsored by
Priovant Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatomyositis focused on measuring brepocitinib, dermatomyositis, TYK2/JAK1 inhibitor, PF-06700841, PVT-2201

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies
  • Adult subjects (18-75 years old)
  • Active muscle and skin disease at screening and baseline
  • Prior therapy OR 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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Brepocitinib Dose Level 1 PO QD

Brepocitinib Dose Level 2 PO QD

Placebo PO QD

Arm Description

Outcomes

Primary Outcome Measures

Total Improvement Score (TIS) at Week 52
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 American College of Rheumatology [ACR] Myositis Response Criteria/European League Against Rheumatism [EULAR]) where a higher score indicates more improvement

Secondary Outcome Measures

TIS responder rate after 52 weeks of brepocitinib administration QD, in comparison to placebo
Proportion of responders, defined as achieving TIS ≥ 40 points (moderate improvement) at Week 52
Change from baseline in HAQ Disability Index score at Week 52
Change from baseline in HAQ Disability Index score at Week 52. Health Assessment Questionnaire (HAQ) Disability Index: Score for function and disability from 0 [without any difficulty] to 3 [unable to do]. Higher score associated with worse outcome.
Cutaneous Dermatomyositis Area and Severity Index (CDASI) Activity Score after 52 weeks of brepocitinib administration QD, in comparison to placebo
Change from baseline in Cutaneous Dermatomyositis Area and Severity Index (CDASI) Activity score at Week 52. Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score 0 to 100 with higher scores indicating a worse outcome.
Normalized change from baseline area under the concentration-time curve (AUC) in oral prednisone-equivalent dose through Week 52

Full Information

First Posted
June 24, 2022
Last Updated
September 29, 2023
Sponsor
Priovant Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05437263
Brief Title
A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Priovant Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatomyositis
Keywords
brepocitinib, dermatomyositis, TYK2/JAK1 inhibitor, PF-06700841, PVT-2201

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brepocitinib Dose Level 1 PO QD
Arm Type
Experimental
Arm Title
Brepocitinib Dose Level 2 PO QD
Arm Type
Experimental
Arm Title
Placebo PO QD
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Brepocitinib
Intervention Description
Oral Brepocitinib
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Placebo
Primary Outcome Measure Information:
Title
Total Improvement Score (TIS) at Week 52
Description
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 American College of Rheumatology [ACR] Myositis Response Criteria/European League Against Rheumatism [EULAR]) where a higher score indicates more improvement
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
TIS responder rate after 52 weeks of brepocitinib administration QD, in comparison to placebo
Description
Proportion of responders, defined as achieving TIS ≥ 40 points (moderate improvement) at Week 52
Time Frame
52 weeks
Title
Change from baseline in HAQ Disability Index score at Week 52
Description
Change from baseline in HAQ Disability Index score at Week 52. Health Assessment Questionnaire (HAQ) Disability Index: Score for function and disability from 0 [without any difficulty] to 3 [unable to do]. Higher score associated with worse outcome.
Time Frame
52 weeks
Title
Cutaneous Dermatomyositis Area and Severity Index (CDASI) Activity Score after 52 weeks of brepocitinib administration QD, in comparison to placebo
Description
Change from baseline in Cutaneous Dermatomyositis Area and Severity Index (CDASI) Activity score at Week 52. Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score 0 to 100 with higher scores indicating a worse outcome.
Time Frame
52 weeks
Title
Normalized change from baseline area under the concentration-time curve (AUC) in oral prednisone-equivalent dose through Week 52
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of dermatomyositis according to 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies Adult subjects (18-75 years old) Active muscle and skin disease at screening and baseline Prior therapy OR 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 or cardiovascular disease Participants with a high risk for herpes zoster reactivation Participants with active or recent infections
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Administrator
Phone
(212) 634-9743
Email
ValorStudyManager@PriovantTx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noriko Iikuni, MD
Organizational Affiliation
VP, Clinical Development
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Irvine
State/Province
California
ZIP/Postal Code
92617
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
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Clinical Trial Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
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City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Vancouver
State/Province
British Colombia
ZIP/Postal Code
V5Y1K2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Concepción
State/Province
Region Del Bio Bio
ZIP/Postal Code
4070280
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Recoleta
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Santiago
ZIP/Postal Code
7640881
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Santiago
ZIP/Postal Code
8331150
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Prague
ZIP/Postal Code
128 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Berlin
ZIP/Postal Code
15562
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Pécs
ZIP/Postal Code
7632
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Tel HaShomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Bari
ZIP/Postal Code
70126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64718
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Guadalajara
ZIP/Postal Code
44690
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
San Luis Potosí
ZIP/Postal Code
78290
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Kraków
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Lublin
ZIP/Postal Code
20-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Nowa Sól
ZIP/Postal Code
67-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Poznań
ZIP/Postal Code
61-293
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Warsaw
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Bucharest
ZIP/Postal Code
011172
Country
Romania
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Cluj-Napoca
ZIP/Postal Code
400000
Country
Romania
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Timişoara
ZIP/Postal Code
300373
Country
Romania
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Nové Mesto Nad Váhom
ZIP/Postal Code
91501
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Mataró
ZIP/Postal Code
8302
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
İzmir
ZIP/Postal Code
35210
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
İzmit
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Clinical Trial Site
City
Manchester
ZIP/Postal Code
M13 9PT
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
Links:
URL
http://www.valorstudy.com
Description
Study Website

Learn more about this trial

A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis

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