Moderate to Severe Psoriatic ArthritisPhase 2NCT07801495
A Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis
A Phase 2 study testing DDY391 in people with Moderate to Severe Psoriatic Arthritis, run by Novartis Pharmaceuticals at 3 sites in United States.
Trial summary
The purpose of this Phase 2a/b study is: 1. to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis (PsA). 2. to determine the dose-response relationship of DDY391 in participants with PsA to support dose selection for Phase 3. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Moderate to Severe Psoriatic Arthritis
- What is being tested?
- DDY391
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Oct 2026to 12 Jan 2029
- Phase
- Phase 2
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male participants at least 18 years of age.
- Diagnosis of PsA and meeting classification criteria for Psoriatic arthritis (CASPAR) at screening.
- Moderate to severe PsA at screening and baseline.
Who cannot join
- Presence of inflammatory conditions other than psoriasis or PsA including but not limited to those associated with arthralgia or arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, scleroderma, sarcoidosis) or presence of fibromyalgia or osteoarthritis with articular symptoms.
- Use of bDMARD treatment within 4 weeks or 5 half-lives of randomization, whichever is longer
- Prior use of JAK inhibitors or TYK2 inhibitors (e.g., deucravacitinib). Prior use of apremilast is allowed but must not be taken within 4 weeks of baseline.
- Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to baseline.
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
- Any active viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infections.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
United States3 sites, 3 recruiting
- Recruiting
Precision Comprehensive Research
Colleyville, Texas, 76034
Mohammad Sohail, +1 972 299 8399, mohammadsohail@pccrsolutions.com
Dhiman Basu
- Recruiting
Shelby Research LLC
Memphis, Tennessee, 38119
Pavan Macharla, +1 901 681 9670, shelbyres8686@outlook.com
Ramesh C Gupta
- Recruiting
Rheumatology Associates of South Texas
San Antonio, Texas, 78251
Veronica Gonzales, VGonzales@biopharmainfo.net
Jane Barbosa Ayala
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2a/b Study Assessing the Efficacy, Safety and Tolerability of DDY391 in Participants With Active Moderate to Severe Psoriatic Arthritis
The purpose of this Phase 2a/b study is:
- to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis (PsA).
- to determine the dose-response relationship of DDY391 in participants with PsA to support dose selection for Phase 3.
Read the detailed description
This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy, safety, tolerability and dose-response relationship of DDY391 in participants with active moderate to severe PsA.
The study is composed of two sequential parts:
- Part A to evaluate efficacy, safety and tolerability of DDY391 compared with placebo.
- Part B to determine the dose-response relationship of multiple doses of DDY391 compared with placebo.
- Conditions
- Moderate to Severe Psoriatic Arthritis
- Being tested
- DDY391, Placebo
- Keywords
- Psoriatic arthritis, Psoriasis, bDMARD, csDMARD, ACR50, Molecular Glue Degrader, VAV1
- Medical subject headings
- Arthritis, Psoriatic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDY391Drug
DDY391
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A: DDY391-Schedule 1 Dose A | Experimental | Participants will receive DDY391 Schedule 1 Dose A. Receives: Drug: DDY391 |
| Part A: Placebo Schedule 1 | Placebo comparator | Participants will receive matching placebo Schedule 1. Receives: Drug: Placebo |
| Part B: DDY391- Schedule 1 Dose A | Experimental | Participants will receive DDY391 Schedule 1 Dose A. Based on treatment response, participants will then either continue receiving DDY391 or switch to local standard of care (SOC). Receives: Drug: DDY391 |
| Part B: DDY391- Schedule 1 Dose B | Experimental | Participants will receive DDY391 Schedule 1 Dose B. Based on treatment response, participants will then either continue receiving DDY391 or switch to local SOC. Receives: Drug: DDY391 |
| Part B: DDY391- Schedule 1 Dose C | Experimental | Participants will receive DDY391 Schedule 1 Dose C. Based on treatment response, participants will then either continue receiving DDY391 or switch to local SOC. Receives: Drug: DDY391 |
| Part B: Placebo Schedule 1 | Experimental | Participants will receive matching placebo Schedule 1. Based on treatment response, participants will then either switch to DDY391 Schedule 1 Dose A or receive local SOC. Receives: Drug: Placebo |
| Part B: DDY391- Schedule 2 Dose C | Experimental | Participants will receive DDY391 Schedule 2 Dose C. Based on treatment response, participants will then either switch to DDY391 Schedule 1 Dose A or receive local SOC. Receives: Drug: DDY391 |
| Part B: Placebo Schedule 2 | Experimental | Participants will receive matching placebo Schedule 2. Based on treatment response, participants will then either switch to DDY391 Schedule 1 Dose A or receive local SOC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of participants achieving American College of Rheumatology 50 (ACR50) response
To evaluate the efficacy of DDY391 versus placebo through achievement of ACR 50. ACR 50 is a validated tool for assessing RA disease activity.
Measured: Week 12
Part A and B: Number of participants achieving American College of Rheumatology 50 (ACR50) response
To demonstrate the dose-response relationship of DDY391 compared to placebo in bDMARD-IR participants.
Measured: Week 12
Secondary outcomes (2)
Part B: Number of participants achieving American College of Rheumatology 50 (ACR50) response
To demonstrate the dose-response relationship of DDY391 compared to placebo in participants.
Measured: Week 12
Part A and Part B: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Measured: From first dose through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start14 Oct 2026 (estimated)
- Primary completion13 Dec 2028 (estimated)
- Study completion12 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801495
- Sponsor's protocol ID
- CDDY391A12201
- Other IDs
- 2025-524512-10, 2025
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com