Arthritis, PsoriaticPhase 2NCT05640245
Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis
A Phase 2 study testing Sonelokimab and Adalimumab in people with Arthritis, Psoriatic, run by MoonLake Immunotherapeutics AG at 42 sites in 8 countries.
Trial summary
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic
- What is being tested?
- Sonelokimab and Adalimumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 42 sitesin 8 countries
- Study dates
- 13 Dec 2022to 15 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is ≥18 years of age;
- Participant has a confirmed diagnosis of PsA per the 2006 Classification criteria for Psoriatic Arthritis (CASPAR) with symptoms for ≥6 months prior to the Screening Visit;
- Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3);
- Participant has either current active PsO or a dermatologist confirmed history of PsO;
- Participant tests negative for rheumatoid factor (RF) at the Screening Visit;
- Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit;
- Participant must be, in the opinion of the investigator, a suitable candidate for treatment with adalimumab per approved local product information.
Who cannot join
- Participant with known hypersensitivity to sonelokimab or any of its excipients;
- Participant with known hypersensitivity to adalimumab or any of its excipients;
- Participant who has previously failed on anti-interleukin (IL)-17 therapy;
- Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy;
- Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit;
- Participant who has a diagnosis of chronic inflammatory conditions other than PsO or PsA;
- Participant who has a diagnosis of arthritis mutilans
Trial locations and contacts
42 sites in 8 countries.
42 sites in 8 countries
Poland17 sites
Clinical Site
Bialystok, 15-077
Clinical Site
Bialystok, 15-351
Clinical Site
Bialystok, 15-879
Clinical Site
Bydgoszcz, 85-065
Clinical Site
Bydgoszcz, 85-168
Clinical Site
Elblag, 82-300
Clinical Site
Gdynia, 81-338
Clinical Site
Krakow, 30-727
Clinical Site
Lodz, 90-242
Clinical Site
Nadarzyn, 05-830
Clinical Site
Nowa Sól, 67-100
Clinical Site
Olsztyn, 10-117
Clinical Site
Poznan, 61-113
Clinical Site
Sochaczew, 96-500
Clinical Site
Swidnica, 58-100
Clinical Site
Warsaw, 02-665
Clinical SIte
Wroclaw, 52-416
Bulgaria8 sites
Clinical Site
Pleven, 5800
Clinical Site
Pleven, 5803
Clinical Site
Plovdiv, 4002
Clinical Site
Plovdiv, 4003
Clinical Site
Rousse, 7002
Clinical Site
Sofia, 1336
Clinical Site
Stara Zagora, 6000
Clinical Site
Varna, 9000
Hungary6 sites
Clinical Site
Budapest, 1023
Clinical Site
Budapest, 1027
Clinical Site
Budapest, 1036
Clinical Site
Székesfehérvár, 8000
Clinical Site
Szentes, 6600
Clinical Site
Veszprém, 8200
Spain4 sites
Clinical Site
Madrid, 28100
Clinical Site
Sabadell, 8208
Clinical Site
Santiago de Compostela, 15702
Clinical Site
Seville, 41010
United States2 sites
Clinical Site
Duncansville, Pennsylvania, 16635
Clinical Site
Rancho Mirage, California, 92260
About this study
Official title: Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.
Read the detailed description
Patients will be randomized to receive one of three sonelokimab treatment regimes, adalimumab or placebo. Primary efficacy evaluation will take place at Week 12. Patients will be allocated to a further 12 weeks of treatment with sonelokimab or adalimumab based on response assessment at week 12. In certain countries, treatment will end at week 12.
- Conditions
- Arthritis, Psoriatic
- Being tested
- Sonelokimab, Placebo, Adalimumab
- Keywords
- Arthritis, Psoriatic, Skin Diseases, Joint Diseases, Arthritis, Psoriasis
- Medical subject headings
- Arthritis, Psoriatic, Skin Diseases, Joint Diseases, Arthritis, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonelokimabDrug
Also called M1095
randomized treatment; parallel group
PlaceboDrug
randomized treatment; parallel-group
AdalimumabDrug
randomized treatment; parallel-group
| Study group | Role | What they receive |
|---|---|---|
| sonelokimab dose regimen 1 | Experimental | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 1 Receives: Drug: Sonelokimab |
| sonelokimab dose regimen 2 | Experimental | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 2 Receives: Drug: Sonelokimab |
| sonelokimab dose regimen 3 | Experimental | Subjects randomized to this arm will receive assigned sonelokimab dosage regimen 3 Receives: Drug: Sonelokimab |
| Placebo | Placebo comparator | Subjects randomized to this arm will receive placebo Receives: Drug: Placebo |
| adalimumab | Active comparator | Subjects randomized to this arm will receive adalimumab Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12
The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) participant's assessment of arthritis pain (PtAAP) on a Visual Analog Scale (VAS, no pain =0 to severe pain =100); 2) participant's global assessment of disease activity (PtGADA) on a VAS (very well =0 to very poor =100); 3) physician's global assessment of disease activity (phGADA) on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) high sensitivity C-reactive protein (hs-CRP, decrease indicates improvement). A non-responder imputation (NRI) method was used for missing data.
Measured: At Week 12
Secondary outcomes (8)
Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, and 8 and 12
The ACR20 response criteria was a response of at least 20% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 20% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data. ACR20 response rate at Week 12 was analyzed as a key secondary outcome measure.
Measured: At Weeks 2, 4, 8, and 12
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 4, 8 and 12, in Participants With Psoriasis Involving at Least 3% Body Surface Area (BSA) at Baseline
The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI90 response was defined as greater than or equal to 90% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data. PASI90 response at Week 12 was analyzed as a key secondary outcome measure.
Measured: At Weeks 4, 8, and 12
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, and 8
The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data.
Measured: At Weeks 2, 4, and 8
Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Weeks 2, 4, 8, and 12
The ACR70 response criteria was a response of at least 70% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 70% improvement from baseline in at least 3 of the following 5 variables: 1) PtAAP on a VAS (no pain =0 to severe pain =100); 2) PtGADA on a VAS (very well =0 to very poor =100); 3) phGADA on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the HAQ-DI (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) hs-CRP (decrease indicates improvement). An NRI method was used for missing data.
Measured: At Weeks 2, 4, 8, and 12
Percentage of Participants Achieving Minimal Disease Activity at Week 12
Minimal disease activity was defined as meeting 5 of the following 7 criteria: tender joint count (68 joints) ≤1; swollen joint count (66 joints) ≤1; psoriasis area and severity index ≤1 or psoriasis affecting ≤1% of body surface area; PtAAP ≤15 on a VAS (0 = no pain to 100 = severe pain); PtGADA ≤20 on a VAS (0 = very well to 100 = very poor); HAQ-DI ≤0.5 (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and Leeds Enthesitis Index (LEI) ≤1 (overall score ranging from 0 to 6, with higher scores indicating greater disease severity). An NRI method was used for missing data.
Measured: At Week 12
Percentage of Participants Who Achieved a PASI75 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline
The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI75 response was defined as greater than or 75% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data.
Measured: At Week 12
Percentage of Participants Achieving a PASI100 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline
The PASI is a validated tool to dynamically assess psoriasis severity. The PASI produces a numeric score that ranges from 0 (no disease) to 72 (maximal disease). A PASI100 response was defined as 100% improvement (reduction) in PASI score from baseline. An NRI method was used for missing data.
Measured: At Week 12
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 12
The mNAPSI is a tool to assess psoriatic nail involvement. Three groups of features (pitting, onycholysis, and oil-drop dyshromia and crumbling) for each fingernail are graded on a scale from 0 to 3. Four features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula) are graded as either present (1) or absent (0) in each fingernail. The total score was calculated by summing the score for each feature and each fingernail and ranged from 0 to 130, with higher scores indicating greater nail disease. A negative change from baseline indicated an improvement in nail disease.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start13 Dec 2022
- Primary completion5 Sep 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, PsoriaticStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- MoonLake Immunotherapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, MoonLake Immunotherapeutics AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640245
- Sponsor's protocol ID
- M1095-PSA-201
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2022
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McInnes IB, Coates LC, Mease PJ, Ogdie A, Kavanaugh A, Eder L, Schett G, Kivitz A, McGonagle D, Brennan N, Godwood A, Cullen E, Reich K, Ritchlin CT, Merola JF. Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial. Nat Med. 2025 Dec;31(12):4160-4171. doi: 10.1038/s41591-025-03971-6. Epub 2025 Oct 6.
PubMed 41053449
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Parallel-group, Double-blind, Placebo-controlled Study of Sonelokimab in Patients With Active Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT05640245
- Acronym / sponsor ID
- M1095-PSA-201
- Conditions
- Arthritis, Psoriatic
- Keywords
- Arthritis, Psoriatic, Skin Diseases, Joint Diseases, Arthritis, Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- MoonLake Immunotherapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Posted 10 Sep 2026
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 study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.
Detailed description
Patients will be randomized to receive one of three sonelokimab treatment regimes, adalimumab or placebo. Primary efficacy evaluation will take place at Week 12. Patients will be allocated to a further 12 weeks of treatment with sonelokimab or adalimumab based on response assessment at week 12. In certain countries, treatment will end at week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| sonelokimab dose regimen 1 | Experimental | Drug: SonelokimabSubjects randomized to this arm will receive assigned sonelokimab dosage regimen 1 |
| sonelokimab dose regimen 2 | Experimental | Drug: SonelokimabSubjects randomized to this arm will receive assigned sonelokimab dosage regimen 2 |
| sonelokimab dose regimen 3 | Experimental | Drug: SonelokimabSubjects randomized to this arm will receive assigned sonelokimab dosage regimen 3 |
| Placebo | Placebo comparator | Drug: PlaceboSubjects randomized to this arm will receive placebo |
| adalimumab | Active comparator | Drug: AdalimumabSubjects randomized to this arm will receive adalimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is ≥18 years of age;
- Participant has a confirmed diagnosis of PsA per the 2006 Classification criteria for Psoriatic Arthritis (CASPAR) with symptoms for ≥6 months prior to the Screening Visit;
- Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3);
- Participant has either current active PsO or a dermatologist confirmed history of PsO;
- Participant tests negative for rheumatoid factor (RF) at the Screening Visit;
Key exclusion criteria (7 listed)
- Participant with known hypersensitivity to sonelokimab or any of its excipients;
- Participant with known hypersensitivity to adalimumab or any of its excipients;
- Participant who has previously failed on anti-interleukin (IL)-17 therapy;
- Participant who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy;
- Participant who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit;
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 |
|---|---|---|
| SonelokimabAlso: M1095randomized treatment; parallel group | Drug | sonelokimab dose regimen 1, sonelokimab dose regimen 2, sonelokimab dose regimen 3 |
| Placeborandomized treatment; parallel-group | Drug | Placebo |
| Adalimumabrandomized treatment; parallel-group | Drug | adalimumab |
Primary outcome
Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12
Time frame: At Week 12
The ACR50 response criteria was a response of at least 50% improvement from baseline based on both swollen joint count (66 joints) and tender joint count (68 joints), and at least 50% improvement from baseline in at least 3 of the following 5 variables: 1) participant's assessment of arthritis pain (PtAAP) on a Visual Analog Scale (VAS, no pain =0 to severe pain =100); 2) participant's global assessment of disease activity (PtGADA) on a VAS (very well =0 to very poor =100); 3) physician's global assessment of disease activity (phGADA) on a VAS (very well =0 to very poor =100); 4) participant's assessment of physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) (overall score ranging from 0 [mild disability] to 3 [very severe disability]); and 5) high sensitivity C-reactive protein (hs-CRP, decrease indicates improvement). A non-responder imputation (NRI) method was used for missing data.
8 secondary outcomes
Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, and 8 and 12
Time frame: At Weeks 2, 4, 8, and 12
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 4, 8 and 12, in Participants With Psoriasis Involving at Least 3% Body Surface Area (BSA) at Baseline
Time frame: At Weeks 4, 8, and 12
Percentage of Participants Achieving an ACR50 Response at Weeks 2, 4, and 8
Time frame: At Weeks 2, 4, and 8
Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Weeks 2, 4, 8, and 12
Time frame: At Weeks 2, 4, 8, and 12
Percentage of Participants Achieving Minimal Disease Activity at Week 12
Time frame: At Week 12
Percentage of Participants Who Achieved a PASI75 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline
Time frame: At Week 12
Percentage of Participants Achieving a PASI100 Response at Week 12, in Participants With Psoriasis Involving at Least 3% BSA at Baseline
Time frame: At Week 12
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 12
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41053449McInnes IB, Coates LC, Mease PJ, Ogdie A, Kavanaugh A, Eder L, Schett G, Kivitz A, McGonagle D, Brennan N, Godwood A, Cullen E, Reich K, Ritchlin CT, Merola JF. Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial. Nat Med. 2025 Dec;31(12):4160-4171. doi: 10.1038/s41591-025-03971-6. Epub 2025 Oct 6.
- Individual participant dataSharing planned: No
Related trials for Arthritis, Psoriatic
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis
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.
MD study director
MoonLake Immunotherapeutics AG
42 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sonelokimab and Adalimumab in people with Arthritis, Psoriatic, run by MoonLake Immunotherapeutics AG at 42 sites in 8 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 7 inclusion and 7 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 10 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 42 sites in Poland, Bulgaria, Hungary, Spain, United States and 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12 (time frame: At Week 12). 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 NCT05640245, which also lists 1 linked publication.
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 10 Sep 2026.