A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
7 september 2026 uppdaterad av: Novartis Pharmaceuticals
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
344
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Novartis Pharmaceuticals
- Telefonnummer: 1-888-669-6682
- E-post: novartis.email@novartis.com
Studera Kontakt Backup
- Namn: Novartis Pharmaceuticals
- Telefonnummer: +41613241111
Studieorter
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Queensland
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Southport, Queensland, Australien, 4222
- Rekrytering
- Novartis Investigative Site
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Florida
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Tampa, Florida, Förenta staterna, 33603
- Rekrytering
- Clinical Research of West Florida Inc
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Huvudutredare:
- John Carter
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Kontakt:
- Sydney K Mullen
- Telefonnummer: +1 813 870 1292
- E-post: smullen@crwf.com
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73116
- Rekrytering
- RAO Research LLC
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Huvudutredare:
- Latisha Heinlen
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Kontakt:
- Erica Beer
- Telefonnummer: +1 405 608 8060
- E-post: ebeer@raoklahoma.com
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Texas
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Bellaire, Texas, Förenta staterna, 77401
- Rekrytering
- Novel Research LLC
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Huvudutredare:
- Wajeeha Yousaf
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Kontakt:
- Hassan Khan
- Telefonnummer: +1 281 944 3610
- E-post: khan@novelresearch.net
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Kfar Saba, Israel, 4428164
- Rekrytering
- Novartis Investigative Site
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Petah Tikva, Israel, 4941492
- Rekrytering
- Novartis Investigative Site
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Ramat Gan, Israel, 5265601
- Rekrytering
- Novartis Investigative Site
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Ẕerifin, Israel, 7030000
- Rekrytering
- Novartis Investigative Site
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Quebec
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Sherbrooke, Quebec, Kanada, J1G 2E8
- Rekrytering
- Novartis Investigative Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Key Inclusion Criteria:
• 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:
- Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness.
Exclusion based on medications being used for SjD:
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Part A- DDY391 dose level 1
DDY391 dose level 1
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DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
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Experimentell: Part A-Placebo
Matching placebo.
At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
|
Matchande placebo
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
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Experimentell: Part B- DDY391 dose level 1
DDY391 dose level 1
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DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
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Experimentell: Part B- DDY391 dose level 2
DDY391 dose level 2
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DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
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Experimentell: Part B- DDY391 dose level 3
DDY391 dose level 3
|
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
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Experimentell: Part B- Placebo
Matching placebo.
At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
|
Matchande placebo
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
|
Experimentell: Part C- DDY391 dose level 1
DDY391 dose level 1
|
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
|
Experimentell: Part C- Placebo
Matching placebo.
At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
|
Matchande placebo
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Part A and B: Change from baseline in ESSDAI score
Tidsram: 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.
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Baseline, Week 24
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Part C: Change from baseline in ESSPRI
Tidsram: Baseline, Week 24
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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).
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Baseline, Week 24
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Part A and B: Change from baseline in ESSPRI
Tidsram: 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).
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Baseline, Week 24
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Part A, B and C: Change from baseline in SSSD
Tidsram: Baseline, Week 24
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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).
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Baseline, Week 24
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Part A, B and C: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: Baseline up to Week 52
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To evaluate the safety and tolerability of multiple doses of DDY391.
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Baseline up to Week 52
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
24 augusti 2026
Primärt slutförande (Beräknad)
19 februari 2029
Avslutad studie (Beräknad)
19 mars 2029
Studieregistreringsdatum
Först inskickad
27 juli 2026
Först inskickad som uppfyllde QC-kriterierna
27 juli 2026
Första postat (Faktisk)
30 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Muskuloskeletala sjukdomar
- Munsjukdomar
- Stomatogena sjukdomar
- Artrit
- Ledsjukdomar
- Reumatiska sjukdomar
- Bindvävssjukdomar
- Autoimmuna sjukdomar
- Immunsystemets sjukdomar
- Ögonsjukdomar
- Artrit, reumatoid
- Xerostomi
- Spottkörtelsjukdomar
- Torra ögon syndrom
- Sjukdomar i tårapparat
- Hud- och bindvävssjukdomar
- Sjögrens syndrom
Andra studie-ID-nummer
- CDDY391B12201
- 2025 (U.S.S. NIH-anslag/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524513-92-00 (Annan identifierare: EU CTIS)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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