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A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease

7. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

344

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Novartis Pharmaceuticals
  • Telefonnummer: +41613241111

Studiesteder

  • Australien
    • Queensland
      • Southport, Queensland, Australien, 4222
        • Rekruttering
        • Novartis Investigative Site
  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • Rekruttering
        • Novartis Investigative Site
  • Forenede Stater
    • Florida
      • Tampa, Florida, Forenede Stater, 33603
        • Rekruttering
        • Clinical Research of West Florida Inc
        • Ledende efterforsker:
          • John Carter
        • Kontakt:
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73116
        • Rekruttering
        • RAO Research LLC
        • Ledende efterforsker:
          • Latisha Heinlen
        • Kontakt:
    • Texas
      • Bellaire, Texas, Forenede Stater, 77401
        • Rekruttering
        • Novel Research LLC
        • Ledende efterforsker:
          • Wajeeha Yousaf
        • Kontakt:
  • Israel
      • Kfar Saba, Israel, 4428164
        • Rekruttering
        • Novartis Investigative Site
      • Petah Tikva, Israel, 4941492
        • Rekruttering
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • Rekruttering
        • Novartis Investigative Site
      • Ẕerifin, Israel, 7030000
        • Rekruttering
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part A- DDY391 dose level 1
DDY391 dose level 1
Medicin: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Eksperimentel: Part A-Placebo
Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
Medicin: Placebo
Matchende placebo
Medicin: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Eksperimentel: Part B- DDY391 dose level 1
DDY391 dose level 1
Medicin: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Eksperimentel: Part B- DDY391 dose level 2
DDY391 dose level 2
Medicin: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Eksperimentel: Part B- DDY391 dose level 3
DDY391 dose level 3
Medicin: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Eksperimentel: Part B- Placebo
Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
Medicin: Placebo
Matchende placebo
Medicin: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Eksperimentel: Part C- DDY391 dose level 1
DDY391 dose level 1
Medicin: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Eksperimentel: Part C- Placebo
Matching placebo. At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
Medicin: Placebo
Matchende placebo
Medicin: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part A and B: Change from baseline in ESSDAI score
Tidsramme: 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.
Baseline, Week 24
Part C: Change from baseline in ESSPRI
Tidsramme: 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).
Baseline, Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Part A and B: Change from baseline in ESSPRI
Tidsramme: 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).
Baseline, Week 24
Part A, B and C: Change from baseline in SSSD
Tidsramme: Baseline, Week 24
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).
Baseline, Week 24
Part A, B and C: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline up to Week 52
To evaluate the safety and tolerability of multiple doses of DDY391.
Baseline up to Week 52

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. august 2026

Primær færdiggørelse (Anslået)

19. februar 2029

Studieafslutning (Anslået)

19. marts 2029

Datoer for studieregistrering

Først indsendt

27. juli 2026

Først indsendt, der opfyldte QC-kriterier

27. juli 2026

Først opslået (Faktiske)

30. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDDY391B12201
  • 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524513-92-00 (Anden identifikator: EU CTIS)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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