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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 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

344

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Novartis Pharmaceuticals
  • Telefonnummer: +41613241111

Studiesteder

  • Australia
    • Queensland
      • Southport, Queensland, Australia, 4222
        • Rekruttering
        • Novartis Investigative Site
  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • Rekruttering
        • Novartis Investigative Site
  • Forente stater
    • Florida
      • Tampa, Florida, Forente stater, 33603
        • Rekruttering
        • Clinical Research of West Florida Inc
        • Hovedetterforsker:
          • John Carter
        • Ta kontakt med:
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73116
        • Rekruttering
        • RAO Research LLC
        • Hovedetterforsker:
          • Latisha Heinlen
        • Ta kontakt med:
    • Texas
      • Bellaire, Texas, Forente stater, 77401
        • Rekruttering
        • Novel Research LLC
        • Hovedetterforsker:
          • Wajeeha Yousaf
        • Ta kontakt med:
  • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Part A- DDY391 dose level 1
DDY391 dose level 1
Legemiddel: DDY391

DDY391 dose level 1

DDY391 dose level 2

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

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Eksperimentell: Part B- DDY391 dose level 1
DDY391 dose level 1
Legemiddel: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Eksperimentell: Part B- DDY391 dose level 2
DDY391 dose level 2
Legemiddel: DDY391

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Eksperimentell: Part B- DDY391 dose level 3
DDY391 dose level 3
Legemiddel: DDY391

DDY391 dose level 1

DDY391 dose level 2

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

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3
Eksperimentell: Part C- DDY391 dose level 1
DDY391 dose level 1
Legemiddel: DDY391

DDY391 dose level 1

DDY391 dose level 2

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

DDY391 dose level 1

DDY391 dose level 2

DDY391 dose level 3

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. august 2026

Primær fullføring (Antatt)

19. februar 2029

Studiet fullført (Antatt)

19. mars 2029

Datoer for studieregistrering

Først innsendt

27. juli 2026

Først innsendt som oppfylte QC-kriteriene

27. juli 2026

Først lagt ut (Faktiske)

30. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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