Moderate to Severe Psoriatic ArthritisPhase 2NCT07923773
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
A Phase 2 study testing DDY391 in people with Moderate to Severe Psoriatic Arthritis, run by Novartis Pharmaceuticals.
Trial summary
The purpose of this 1-year open-label extension study is to characterize the longer-term safety and tolerability of DDY391 and to assess the durability of clinical response in participants with Psoriatic Arthritis (PsA) who have completed treatment in the CDDY391A12201 core study. 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?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2027to 11 Jan 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Participants must have completed study treatment in CDDY391A12201 and must not meet any treatment discontinuation criteria of the core study at the time of OLE enrollment.
Who cannot join
- Participants taking other prohibited therapies, including but not limited to, high-potency opioids.
- Received live attenuated vaccines 4 weeks prior to baseline or anticipated during the study or within 4 weeks of stopping the study drug.
- Any active viral, bacterial or other infections at the time of extension study entry or history of recurrent clinically significant infection or of recurrent bacterial infections.
- Women of childbearing potential unwilling to use protocol specified method of contraception.
- Sexually active males unwilling to use a condom during intercourse while taking study treatment and for at least 28 days after stopping study treatment are excluded.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: An Open-label Extension Study to Assess the Safety and Tolerability of DDY391 in Adult Participants With Active Moderate to Severe Psoriatic Arthritis Who Have Completed Study Treatment in CDDY391A12201
The purpose of this 1-year open-label extension study is to characterize the longer-term safety and tolerability of DDY391 and to assess the durability of clinical response in participants with Psoriatic Arthritis (PsA) who have completed treatment in the CDDY391A12201 core study.
Read the detailed description
This is a 1-year open label extension (OLE) for participants who completed study treatment in CDDY391A12201 core study. Eligible participants include adults with moderate to severe PsA enrolled in part A or B of the core study who had an inadequate response and/or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs), as well as biologic-naïve participants with an inadequate response and/or intolerance to at least one conventional synthetic DMARD.
Participants must not meet any core study treatment discontinuation criteria at OLE enrollment.
There will be no screening period in this trial. The OLE baseline visit will coincide with Week 12/EOT for Part A and Week 24/EOT for Part B.
Eligible participants will receive open-label DDY391 for up to 52 weeks, followed by a 30-day safety follow-up. The total study duration is 56 weeks.
- Conditions
- Moderate to Severe Psoriatic Arthritis
- Being tested
- DDY391
- Keywords
- Psoriatic arthritis, bDMARD, csDMARD, Molecular Glue Degrader, VAV1, open label extension
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDY391Drug
DDY391
| Study group | Role | What they receive |
|---|---|---|
| DDY391 | Experimental | Participants will receive DDY391 Receives: Drug: DDY391 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Up to 56 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start10 Feb 2027 (estimated)
- Primary completion12 Dec 2029 (estimated)
- Study completion11 Jan 2030 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 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
- NCT07923773
- Sponsor's protocol ID
- CDDY391A12201E1
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study to Assess the Safety and Tolerability of DDY391 in Adult Participants With Active Moderate to Severe Psoriatic Arthritis Who Have Completed Study Treatment in CDDY391A12201
- ClinicalTrials.gov ID
- NCT07923773
- Acronym / sponsor ID
- CDDY391A12201E1
- Conditions
- Moderate to Severe Psoriatic Arthritis
- Keywords
- Psoriatic arthritis, bDMARD, csDMARD, Molecular Glue Degrader, VAV1, open label extension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2027 (estimated)
- Primary completion
- 12 Dec 2029 (estimated)
- Study completion
- 11 Jan 2030 (estimated)
- First posted
- 6 Nov 2026 (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.
The purpose of this 1-year open-label extension study is to characterize the longer-term safety and tolerability of DDY391 and to assess the durability of clinical response in participants with Psoriatic Arthritis (PsA) who have completed treatment in the CDDY391A12201 core study.
Detailed description
This is a 1-year open label extension (OLE) for participants who completed study treatment in CDDY391A12201 core study. Eligible participants include adults with moderate to severe PsA enrolled in part A or B of the core study who had an inadequate response and/or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs), as well as biologic-naïve participants with an inadequate response and/or intolerance to at least one conventional synthetic DMARD.
Participants must not meet any core study treatment discontinuation criteria at OLE enrollment.
There will be no screening period in this trial. The OLE baseline visit will coincide with Week 12/EOT for Part A and Week 24/EOT for Part B.
Eligible participants will receive open-label DDY391 for up to 52 weeks, followed by a 30-day safety follow-up. The total study duration is 56 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DDY391 | Experimental | Drug: DDY391Participants will receive DDY391 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must have completed study treatment in CDDY391A12201 and must not meet any treatment discontinuation criteria of the core study at the time of OLE enrollment.
Key exclusion criteria (6 listed)
- Participants taking other prohibited therapies, including but not limited to, high-potency opioids.
- Received live attenuated vaccines 4 weeks prior to baseline or anticipated during the study or within 4 weeks of stopping the study drug.
- Any active viral, bacterial or other infections at the time of extension study entry or history of recurrent clinically significant infection or of recurrent bacterial infections.
- Women of childbearing potential unwilling to use protocol specified method of contraception.
- Sexually active males unwilling to use a condom during intercourse while taking study treatment and for at least 28 days after stopping study treatment are excluded.
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 |
|---|---|---|
| DDY391DDY391 | Drug | DDY391 |
Primary outcome
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 56 Weeks
Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: 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
Related trials for Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
A Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis
Moderate to Severe Psoriatic Arthritis
Recruiting
Modifying PEST for Psoriatic Arthritis Screening
Plaque Psoriasis, Psoriatic Arthritis
RecruitingPhase 1
A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)
Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis
RecruitingObservational study
Korean Post-marketing Surveillance for Xeljanz XR
Active Moderate to Severe Rheumatoid Arthritis, Active Ankylosing Spondylitis
Active, not recruitingPhase 3
A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis
Moderate to Severe Plaque Psoriasis, 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.
Novartis Pharmaceuticals contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DDY391 in people with Moderate to Severe Psoriatic Arthritis, run by Novartis Pharmaceuticals.
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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 56 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.