Sjögren's DiseasePhase 2NCT07737743
A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
A Phase 2 study testing DDY391 in people with Sjögren's Disease, run by Novartis Pharmaceuticals at 22 sites in 5 countries.
Trial summary
To evaluate efficacy, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, 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
- Sjögren's Disease
- What is being tested?
- DDY391
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 24 Aug 2026to 19 Mar 2029
- 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 a diagnosis of SjD according to the ACR/EULAR 2016 classification criteria at screening:
- Positive anti-Ro (SSA) antibodies at screening. Participants negative for anti-Ro/SSA antibodies are eligible if they have documented previous biopsy showing evidence of salivary gland inflammation consistent with SjD.
Who cannot join
- Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness.
- Participants taking > 400 mg/day hydroxychloroquine are excluded. Participants taking ≤400 mg/day hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization.
- Participants taking > 400 mg/day hydroxychloroquine are excluded. Participants on ≤ 400 mg/day of hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization.
- Prior treatment with any of the following within 3 months prior to randomization: belimumab, abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins, plasmapheresis, intravenous (i.v.) or oral cyclophosphamide, mycophenolate mofetil, i.v. or oral cyclosporine A, or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors, IL-2, anti-IL-6, anti-IL-17).
- Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to screening.
- Any viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infection.
- History of malignancy of any organ system (other than localized non melanoma carcinoma of the skin or in situ cervical cancer) within the last five years of randomization or any malignancy not in remission.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
22 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
22 sites in 5 countries
United States9 sites, 9 recruiting
- Recruiting
Stryde Research-Allen Arthritis
Allen, Texas, 75013
Aarsheya Amin, +1 972 747 0709, aamin@stryderesearch.com
John Lavery
- Recruiting
Novel Research LLC
Bellaire, Texas, 77401
Hassan Khan, +1 281 944 3610, khan@novelresearch.net
Wajeeha Yousaf
- Recruiting
Chicago Clinical Research Inst
Chicago, Illinois, 60607
Saad Hussaini Syed, ssyed@ccrii.us
Dennis Levinson
- Recruiting
Clinical Res Of W Florida
Clearwater, Florida, 33765
Jessica Mayfield, +1 727 466 0078, JMayfield@crwf.com
Rodney Daniel
- Recruiting
Arthritis Care of Texas
Corpus Christi, Texas, 78415
Tatum Trevino, +1 361 400 7700, tatum.trevino@sclamanagement.com
Eric Ping Chiang
- Recruiting
Altoona Center for Clin Res
Duncansville, Pennsylvania, 16635
Nicole Barnhill, nbarnhill@altoonaresearch.com
Alan J Kivitz
- Recruiting
RAO Research LLC
Oklahoma City, Oklahoma, 73116
Erica Beer, +1 405 608 8060, ebeer@raoklahoma.com
Latisha Heinlen
- Recruiting
Clinical Research of West Florida Inc
Tampa, Florida, 33603
Sydney K Mullen, +1 813 870 1292, smullen@crwf.com
John Carter
- Recruiting
Willow Rheumatology Wellness
Willowbrook, Illinois, 60527
Avni Singh, asingh@willowrheum.com
Angela R Crowley
Israel5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Kfar Saba, 4428164
- Recruiting
Novartis Investigative Site
Petah Tikva, 4941492
- Recruiting
Novartis Investigative Site
Ramat Gan, 5265601
- Recruiting
Novartis Investigative Site
Tel Aviv, 6423906
- Recruiting
Novartis Investigative Site
Ẕerifin, 7030000
Canada3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Rimouski, Quebec, G5L 5T1
- Recruiting
Novartis Investigative Site
Sherbrooke, Quebec, J1G 2E8
- Recruiting
Novartis Investigative Site
Trois-Rivières, Quebec, G9A 3Y2
China3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Beijing, 100034
- Recruiting
Novartis Investigative Site
Beijing, 100050
- Recruiting
Novartis Investigative Site
Taiyuan, Shanxi, 030000
Australia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Nedlands, Western Australia, 6009
- Recruiting
Novartis Investigative Site
Southport, Queensland, 4222
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 Sjögren's Disease
To evaluate efficacy, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection for Phase 3.
Read the detailed description
This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multi-center trial involving participants with SjD. The study consists of three parts (Part A, Part B, and Part C).
The study includes a screening period of up to 8 weeks to assess eligibility, a 52-week treatment period, and a 4-week safety follow-up period after the last dose of study treatment.
- Conditions
- Sjögren's Disease
- Being tested
- DDY391, Placebo
- Keywords
- Sjögren's Disease, ESSDAI, ESSPRI
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDY391Drug
DDY391 dose level 1
DDY391 dose level 2
DDY391 dose level 3
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A- DDY391 dose level 1 | Experimental | DDY391 dose level 1 Receives: Drug: DDY391 |
| Part A-Placebo | Experimental | Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2. Receives: Drug: DDY391; Drug: Placebo |
| Part B- DDY391 dose level 1 | Experimental | DDY391 dose level 1 Receives: Drug: DDY391 |
| Part B- DDY391 dose level 2 | Experimental | DDY391 dose level 2 Receives: Drug: DDY391 |
| Part B- DDY391 dose level 3 | Experimental | DDY391 dose level 3 Receives: Drug: DDY391 |
| Part B- Placebo | Experimental | Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2. Receives: Drug: DDY391; Drug: Placebo |
| Part C- DDY391 dose level 1 | Experimental | DDY391 dose level 1 Receives: Drug: DDY391 |
| Part C- Placebo | Experimental | Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2. Receives: Drug: DDY391; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A and B: Change from baseline in ESSDAI score
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a validated tool for assessing disease activity in SjD. Score range is 0-123. Higher scores on the ESSDAI scale are associated with poorer health states. A negative change from baseline indicates improvement in disease status.
Measured: Baseline, Week 24
Part C: Change from baseline in ESSPRI
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a validated disease outcome measure for SjD. It consists of three domains of dryness, pain, and fatigue. The participant will assess severity of symptoms they experienced over the last 14 days on a single 0-10 numerical rating scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3. The total ESSPRI score ranges from 0 (no symptoms) to 10 (maximal symptom severity).
Measured: Baseline, Week 24
Secondary outcomes (3)
Part A and B: Change from baseline in ESSPRI
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a validated disease outcome measure for SjD. It consists of three domains of dryness, pain, and fatigue. The participant will assess severity of symptoms they experienced over the last 14 days on a single 0-10 numerical rating scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3. The total ESSPRI score ranges from 0 (no symptoms) to 10 (maximal symptom severity).
Measured: Baseline, Week 24
Part A, B and C: Change from baseline in SSSD
Sjögren's Syndrome Symptom Diary (SSSD) includes six items specific to SjD (eye dryness, mouth dryness skin dryness, tiredness, muscle and/or joint pain, and genital dryness). The total score ranges from 0 (no symptoms) to 10 (maximal symptom severity).
Measured: Baseline, Week 24
Part A, B and C: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To evaluate the safety and tolerability of multiple doses of DDY391.
Measured: Baseline up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start24 Aug 2026
- Primary completion19 Feb 2029 (estimated)
- Study completion19 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 344 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
- NCT07737743
- Sponsor's protocol ID
- CDDY391B12201
- Other IDs
- 2025-524513-92-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2a/b Study Assessing the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
- ClinicalTrials.gov ID
- NCT07737743
- Acronym / sponsor ID
- CDDY391B12201
- Conditions
- Sjögren's Disease
- Keywords
- Sjögren's Disease, ESSDAI, ESSPRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 19 Feb 2029 (estimated)
- Study completion
- 19 Mar 2029 (estimated)
- First posted
- 30 Jul 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.
To evaluate efficacy, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection for Phase 3.
Detailed description
This study is a Phase 2a/b, randomized, double-blind, placebo-controlled, multi-center trial involving participants with SjD. The study consists of three parts (Part A, Part B, and Part C).
The study includes a screening period of up to 8 weeks to assess eligibility, a 52-week treatment period, and a 4-week safety follow-up period after the last dose of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A- DDY391 dose level 1 | Experimental | Drug: DDY391DDY391 dose level 1 |
| Part A-Placebo | Experimental | Drug: DDY391, Drug: PlaceboMatching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2. |
| Part B- DDY391 dose level 1 | Experimental | Drug: DDY391DDY391 dose level 1 |
| Part B- DDY391 dose level 2 | Experimental | Drug: DDY391DDY391 dose level 2 |
| Part B- DDY391 dose level 3 | Experimental | Drug: DDY391DDY391 dose level 3 |
| Part B- Placebo | Experimental | Drug: DDY391, Drug: PlaceboMatching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2. |
| Part C- DDY391 dose level 1 | Experimental | Drug: DDY391DDY391 dose level 1 |
| Part C- Placebo | Experimental | Drug: DDY391, Drug: PlaceboMatching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must have a diagnosis of SjD according to the ACR/EULAR 2016 classification criteria at screening:
- Positive anti-Ro (SSA) antibodies at screening. Participants negative for anti-Ro/SSA antibodies are eligible if they have documented previous biopsy showing evidence of salivary gland inflammation consistent with SjD.
Key exclusion criteria (8 listed)
- Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness.
- Prior treatment with any of the following within 3 months prior to randomization: belimumab, abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins, plasmapheresis, intravenous (i.v.) or oral cyclophosphamide, mycophenolate mofetil, i.v. or oral cyclosporine A, or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors, IL-2, anti-IL-6, anti-IL-17).
- Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to screening.
- Any viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infection.
- History of malignancy of any organ system (other than localized non melanoma carcinoma of the skin or in situ cervical cancer) within the last five years of randomization or any malignancy not in remission.
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 dose level 1 DDY391 dose level 2 DDY391 dose level 3 | Drug | Part A- DDY391 dose level 1, Part A-Placebo, Part B- DDY391 dose level 1, Part B- DDY391 dose level 2, Part B- DDY391 dose level 3, Part B- Placebo, Part C- DDY391 dose level 1, Part C- Placebo |
| PlaceboMatching Placebo | Drug | Part A-Placebo, Part B- Placebo, Part C- Placebo |
Primary outcome
Part A and B: Change from baseline in ESSDAI score
Time frame: Baseline, Week 24
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) is a validated tool for assessing disease activity in SjD. Score range is 0-123. Higher scores on the ESSDAI scale are associated with poorer health states. A negative change from baseline indicates improvement in disease status.
Part C: Change from baseline in ESSPRI
Time frame: Baseline, Week 24
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a validated disease outcome measure for SjD. It consists of three domains of dryness, pain, and fatigue. The participant will assess severity of symptoms they experienced over the last 14 days on a single 0-10 numerical rating scale for each of the three domains. The ESSPRI score is defined as the mean of scores from the three scales: (dryness + pain + fatigue) /3. The total ESSPRI score ranges from 0 (no symptoms) to 10 (maximal symptom severity).
3 secondary outcomes
Part A and B: Change from baseline in ESSPRI
Time frame: Baseline, Week 24
Part A, B and C: Change from baseline in SSSD
Time frame: Baseline, Week 24
Part A, B and C: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 52
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 13 Oct 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
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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.
Novartis Pharmaceuticals contact
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DDY391 in people with Sjögren's Disease, run by Novartis Pharmaceuticals at 22 sites in 5 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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Israel, Canada, China, Australia. 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. 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?
Part A and B: Change from baseline in ESSDAI score (time frame: Baseline, Week 24). The study lists 2 primary outcomes in all. 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 13 Oct 2026.