DermatomyositisPhase 3VALORNCT05437263
A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis
A Phase 3 study testing Brepocitinib in people with Dermatomyositis, run by Priovant Therapeutics, Inc. at 109 sites in 22 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- Brepocitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 241 participants
- Where
- 109 sitesin 22 countries
- Study dates
- 31 Oct 2022to 9 Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 randomization (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.)
Show all 11Show fewer
- 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
Trial locations and contacts
109 sites in 22 countries.
109 sites in 22 countries
United States39 sites
Clinical Trial Site
Ann Arbor, Michigan, 48103
Clinical Trial Site
Atlanta, Georgia, 30322
Clinical Trial Site
Augusta, Georgia, 30912
Clinical Trial Site
Aurora, Colorado, 80045
Clinical Trial Site
Austin, Texas, 78756
Clinical Trial Site
Baltimore, Maryland, 21224
Clinical Trial Site
Boston, Massachusetts, 02115
Clinical Trial Site
Boynton Beach, Florida, 33472
Clinical Trial Site
Chicago, Illinois, 60637
Clinical Trial Site
Cincinnati, Ohio, 45267
Clinical Trial Site
Cleveland, Ohio, 44195
Clinical Trial Site
Denver, Colorado, 80230
Clinical Trial Site
Gainesville, Florida, 32606
Clinical Trial Site
Houston, Texas, 77030
Clinical Trial Site
Iowa City, Iowa, 52242
Clinical Trial Site
Irvine, California, 92617
Clinical Trial Site
Irving, Texas, 75039
Clinical Trial Site
Jackson, Tennessee, 38305
Clinical Trial Site
Jacksonville, Florida, 32224
Clinical Trial Site
Kansas City, Kansas, 66160
Clinical Trial Site
Los Angeles, California, 90095
Clinical Trial Site
Manhasset, New York, 11030
Clinical Trial Site
Marietta, Georgia, 30060
Clinical Trial Site
Minneapolis, Minnesota, 55455
Clinical Trial Site
New Orleans, Louisiana, 70112
Clinical Trial Site
New Orleans, Louisiana, 70433
Clinical Trial Site
New York, New York, 10017
Clinical Trial Site
New York, New York, 10021
Clinical Trial Site
Oklahoma City, Oklahoma, 73116
Clinical Trial Site
Philadelphia, Pennsylvania, 19104
Clinical Trial Site
Phoenix, Arizona, 85028
Clinical Trial Site
Pittsburgh, Pennsylvania, 15213
Clinical Trial Site
Plantation, Florida, 33324
Clinical Trial Site
Portland, Oregon, 97239
Clinical Trial Site
Rochester, Minnesota, 55905
Clinical Trial Site
San Francisco, California, 94115
Clinical Trial Site
Scottsdale, Arizona, 85258
Clinical Trial Site
Scottsdale, Arizona, 85259
Clinical Trial Site
Tampa, Florida, 33613
Poland7 sites
Clinical Trial Site
Bialystok, Podlaskie Voivodeship, 15-704
Clinical Trial Site
Krakow, 30-363
Clinical Trial Site
Lublin, 20-400
Clinical Trial Site
Lublin, 20-607
Clinical Trial Site
Nowa Sól, 67-100
Clinical Trial Site
Poznan, 61-293
Clinical Trial Site
Warsaw, 02-637
Germany6 sites
Clinical Trial Site
Berlin, 10117
Clinical Trial Site
Berlin, 15562
Clinical Trial Site
Dresden, 01307
Clinical Trial Site
Essen, 45147
Clinical Trial Site
Freiburg im Breisgau, 79106
Clinical Trial Site
Mainz, Rhineland-Palatinate, 55131
Chile5 sites
Clinical Trial Site
Concepción, Biobio, 4070280
Clinical Trial Site
Recoleta, 8420383
Clinical Trial Site
Santiago, 7640881
Clinical Trial Site
Santiago, 8331150
Clinical Trial Site
Temuco, 4800827
Israel5 sites
Clinical Trial Site
Ashkelon, 7830604
Clinical Trial Site
Haifa, 3109601
Clinical Trial Site
Poria – Neve Oved, 1528001
Clinical Trial Site
Tel Aviv, 6423906
Clinical Trial Site
Tel HaShomer, 52621
Mexico5 sites
Clinical Trial Site
Guadalajara, 44690
Clinical Trial Site
Mérida, Yucatán, 97070
Clinical Trial Site
Mexico City, 06700
Clinical Trial Site
Monterrey, Nuevo León, 64718
Clinical Trial Site
San Luis Potosí City, 78290
Turkey (Türkiye)5 sites
Clinical Trial Site
Ankara, 06560
Clinical Trial Site
Antalya, 07070
Clinical Trial Site
Istanbul, 34096
Clinical Trial Site
Izmir, 35210
Clinical Trial Site
İzmit, 41380
Bulgaria4 sites
Clinical Trial Site
Plovdiv, 4000
Clinical Trial Site
Plovdiv, 4001
Clinical Trial Site
Plovdiv, 4004
Clinical Trial Site
Sofia, 1407
Italy4 sites
Clinical Trial Site
Bari, 70126
Clinical Trial Site
Pavia, 27100
Clinical Trial Site
Roma, 00168
Clinical Trial Site
Torino, 10126
Portugal4 sites
Clinical Trial Site
Guimarães, 4835-044
Clinical Trial Site
Lisbon, 1649-028
Clinical Trial Site
Porto, 4099-001
Clinical Trial Site
Vila Nova de Gaia, Porto District, 4434-502
Taiwan4 sites
Clinical Trial Site
Kaohsiung City, 833401
Clinical Trial Site
Taichung, 40447
Clinical Trial Site
Tainan, 710
Clinical Trial Site
Taipei, 10002
Argentina3 sites
Clinical Trial Site
Caba, Buenos Aires F.D., 1425
Clinical Trial Site
Mendoza, 5519
Clinical Trial Site
Quilmes, Buenos Aires, B1878DVB
Hungary3 sites
Clinical Trial Site
Debrecen, 4032
Clinical Trial Site
Pécs, 7632
Clinical Trial Site
Szeged, 6720
United Kingdom3 sites
Clinical Trial Site
Bath, BA1 3NG
Clinical Trial Site
Manchester, M13 9PT
Clinical Trial Site
Wolverhampton, WV10 0QP
Canada2 sites
Clinical Trial Site
Newmarket, Ontario, L3Y 5G8
Clinical Trial Site
Vancouver, British Colombia, V5Y1K2
Netherlands2 sites
Clinical Trial Site
Amsterdam, 1105 AZ
Clinical Trial Site
Nijmegen, Gelderland, 6500 HB
Romania2 sites
Clinical Trial Site
Bucharest, 011172
Clinical Trial Site
Cluj-Napoca, 400000
South Korea2 sites
Clinical Trial Site
Seoul, 03080
Clinical Trial Site
Suwon, 16499
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis
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.
- Conditions
- Dermatomyositis
- Being tested
- Brepocitinib, Placebo
- Keywords
- brepocitinib, dermatomyositis, TYK2/JAK1 inhibitor, PF-06700841, PVT-2201
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrepocitinibDrug
Oral Brepocitinib
PlaceboDrug
Oral Placebo
| Study group | Role | What they receive |
|---|---|---|
| Brepocitinib Dose Level 1 PO QD | Experimental | Not described Receives: Drug: Brepocitinib |
| Brepocitinib Dose Level 2 PO QD | Experimental | Not described Receives: Drug: Brepocitinib |
| Placebo PO QD | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 52 weeks
Secondary outcomes (9)
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52
CDASI Activity Score 0 to 100 with higher scores indicating a worse outcome.
Measured: 52 weeks
Dermatomyositis Outcomes for Muscle and Skin (DMOMS) at Week 52
DMOMS is a composite endpoint based on 4 component measures and ranges from 0 to 100 (Pandya, 2024) where a higher score indicates more improvement.
Measured: 52 weeks
The proportion of participants achieving TIS ≥ 40 points (moderate improvement) at Week 52
Measured: 52 weeks
Time to achievement of consecutive (≥ 2 visits) TIS ≥ 40 points (moderate improvement) by Week 52
Measured: 52 weeks
The proportion of participants, regardless of baseline corticosteroid use, achieving TIS ≥ 40 points (moderate improvement) at Week 52 with 0 to ≤ 2.5 mg/day of oral prednisone (or equivalent) at both Week 48 and Week 52
Measured: 52 weeks
The proportion of participants achieving ≥ 40% improvement with a ≥ 4-point improvement from baseline in CDASI Activity Score at Week 52
Measured: 52 weeks
The proportion of participants achieving TIS ≥ 60 points (major improvement) at Week 52
Measured: 52 weeks
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.
Measured: 52 weeks
Change from baseline in CDASI Activity Score at Week 4
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start31 Oct 2022
- Primary completion17 Jul 2025
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DermatomyositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Priovant Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437263
- Sponsor's protocol ID
- PVT-2201-301
- Other IDs
- 2022-500367-12-00
- Acronym
- VALOR
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Mangold AR, Haemel A, Shahriari N, Chong B, Fernandez AP, Fiorentino D, Pearson D, Sluzevich J, Onajin O, Rambhatla PV, Rashighi M, Hurabielle C, Fivenson D, Boh E, Paravar T, Crew A, Flowers RH, Taylor D, Subhardashani S, Culton D, Schadt C, Callen J, Lam C, Graham L, Hashemi K, Castillo R, Maderal A, Elman S, Shaw KS, Cascino MD, LaChance A, Min MS, Femia A, Vleugels RA, Werth VP. Skin-Specific Outcomes of Brepocitinib in Patients With Dermatomyositis: Secondary Analysis of a Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2026 Aug 26. doi: 10.1001/jamadermatol.2026.3199. Online ahead of print.
PubMed 42646746Vleugels RA, Paik JJ, Bauer Ventura I, Mangold AR, Gandiga PC, Haemel A, Chinoy H, Hussain YM, Sivakumar K, Griger Z, Lee EB, Bozan F, Hsu CY, Femia A, Dimachkie MM, Min MS, Mozaffar T, Charles-Schoeman C, Fernandez DR, Onajin O, Campanilho-Marques R, Marder G, Ernste F, Schiopu E, Sluzevich J, Pearson D, Lindsey S, Luggen M, Bubb MR, Boh E, Maganti R, Heinlen L, Shaw KS, Cascino MD, Mudd PN Jr, Vencovsky J, Fernandez AP, Fiorentino D, Christopher-Stine L, Werth VP, Aggarwal R; VALOR Investigators. A Phase 3 Trial of Brepocitinib in Dermatomyositis. N Engl J Med. 2026 May 14;394(19):1883-1893. doi: 10.1056/NEJMoa2503531. Epub 2026 Mar 28.
PubMed 41910335
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis
- ClinicalTrials.gov ID
- NCT05437263
- Acronym / sponsor ID
- VALOR / PVT-2201-301
- Conditions
- Dermatomyositis
- Keywords
- brepocitinib, dermatomyositis, TYK2/JAK1 inhibitor, PF-06700841, PVT-2201
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Priovant Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brepocitinib Dose Level 1 PO QD | Experimental | Drug: Brepocitinib |
| Brepocitinib Dose Level 2 PO QD | Experimental | Drug: Brepocitinib |
| Placebo PO QD | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- Dermatomyositis with end-stage organ involvement
- Dermatomyositis with irreversible muscle involvement
- History of:
- Overlap myositis/connective tissue disease (except for overlap with Sjögren's syndrome)
- Participants at a risk of thrombosis or cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrepocitinibOral Brepocitinib | Drug | Brepocitinib Dose Level 1 PO QD, Brepocitinib Dose Level 2 PO QD |
| PlaceboOral Placebo | Drug | Placebo PO QD |
Primary outcome
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 American College of Rheumatology [ACR] Myositis Response Criteria/European League Against Rheumatism [EULAR]) where a higher score indicates more improvement
9 secondary outcomes
Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) Activity Score at Week 52
Time frame: 52 weeks
Dermatomyositis Outcomes for Muscle and Skin (DMOMS) at Week 52
Time frame: 52 weeks
The proportion of participants achieving TIS ≥ 40 points (moderate improvement) at Week 52
Time frame: 52 weeks
Time to achievement of consecutive (≥ 2 visits) TIS ≥ 40 points (moderate improvement) by Week 52
Time frame: 52 weeks
The proportion of participants, regardless of baseline corticosteroid use, achieving TIS ≥ 40 points (moderate improvement) at Week 52 with 0 to ≤ 2.5 mg/day of oral prednisone (or equivalent) at both Week 48 and Week 52
Time frame: 52 weeks
The proportion of participants achieving ≥ 40% improvement with a ≥ 4-point improvement from baseline in CDASI Activity Score at Week 52
Time frame: 52 weeks
The proportion of participants achieving TIS ≥ 60 points (major improvement) at Week 52
Time frame: 52 weeks
Change from baseline in HAQ Disability Index score at Week 52
Time frame: 52 weeks
Change from baseline in CDASI Activity Score at Week 4
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Derived from this study: PubMed 42646746Mangold AR, Haemel A, Shahriari N, Chong B, Fernandez AP, Fiorentino D, Pearson D, Sluzevich J, Onajin O, Rambhatla PV, Rashighi M, Hurabielle C, Fivenson D, Boh E, Paravar T, Crew A, Flowers RH, Taylor D, Subhardashani S, Culton D, Schadt C, Callen J, Lam C, Graham L, Hashemi K, Castillo R, Maderal A, Elman S, Shaw KS, Cascino MD, LaChance A, Min MS, Femia A, Vleugels RA, Werth VP. Skin-Specific Outcomes of Brepocitinib in Patients With Dermatomyositis: Secondary Analysis of a Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2026 Aug 26. doi: 10.1001/jamadermatol.2026.3199. Online ahead of print.
- Derived from this study: PubMed 41910335Vleugels RA, Paik JJ, Bauer Ventura I, Mangold AR, Gandiga PC, Haemel A, Chinoy H, Hussain YM, Sivakumar K, Griger Z, Lee EB, Bozan F, Hsu CY, Femia A, Dimachkie MM, Min MS, Mozaffar T, Charles-Schoeman C, Fernandez DR, Onajin O, Campanilho-Marques R, Marder G, Ernste F, Schiopu E, Sluzevich J, Pearson D, Lindsey S, Luggen M, Bubb MR, Boh E, Maganti R, Heinlen L, Shaw KS, Cascino MD, Mudd PN Jr, Vencovsky J, Fernandez AP, Fiorentino D, Christopher-Stine L, Werth VP, Aggarwal R; VALOR Investigators. A Phase 3 Trial of Brepocitinib in Dermatomyositis. N Engl J Med. 2026 May 14;394(19):1883-1893. doi: 10.1056/NEJMoa2503531. Epub 2026 Mar 28.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
109 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brepocitinib in people with Dermatomyositis, run by Priovant Therapeutics, Inc. at 109 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in United States, Poland, Germany, Chile, Israel and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Improvement Score (TIS) at Week 52 (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05437263, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.