A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Novartis Pharmaceuticals
- 전화번호: 1-888-669-6682
- 이메일: novartis.email@novartis.com
연구 연락처 백업
- 이름: Novartis Pharmaceuticals
- 전화번호: +41613241111
연구 장소
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Florida
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Tampa, Florida, 미국, 33603
- 모병
- Clinical Research of West Florida Inc
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수석 연구원:
- John Carter
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연락하다:
- Sydney K Mullen
- 전화번호: +1 813 870 1292
- 이메일: smullen@crwf.com
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73116
- 모병
- RAO Research LLC
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수석 연구원:
- Latisha Heinlen
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연락하다:
- Erica Beer
- 전화번호: +1 405 608 8060
- 이메일: ebeer@raoklahoma.com
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Texas
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Bellaire, Texas, 미국, 77401
- 모병
- Novel Research LLC
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수석 연구원:
- Wajeeha Yousaf
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연락하다:
- Hassan Khan
- 전화번호: +1 281 944 3610
- 이메일: khan@novelresearch.net
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Kfar Saba, 이스라엘, 4428164
- 모병
- Novartis Investigative Site
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Petah Tikva, 이스라엘, 4941492
- 모병
- Novartis Investigative Site
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Ramat Gan, 이스라엘, 5265601
- 모병
- Novartis Investigative Site
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Ẕerifin, 이스라엘, 7030000
- 모병
- Novartis Investigative Site
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Quebec
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Sherbrooke, Quebec, 캐나다, J1G 2E8
- 모병
- Novartis Investigative Site
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Queensland
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Southport, Queensland, 호주, 4222
- 모병
- Novartis Investigative Site
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: Part A-Placebo
Matching placebo.
At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
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일치하는 위약
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
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실험적: 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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실험적: 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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실험적: Part B- DDY391 dose level 3
DDY391 dose level 3
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DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
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실험적: Part B- Placebo
Matching placebo.
At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
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일치하는 위약
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
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실험적: Part C- 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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실험적: Part C- Placebo
Matching placebo.
At the Week 24 visit, all participants will be randomized to DDY391 dose level 1 or dose level 2.
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일치하는 위약
DDY391 dose level 1 DDY391 dose level 2 DDY391 dose level 3 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Part A and B: Change from baseline in ESSDAI score
기간: Baseline, Week 24
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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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Part A and B: Change from baseline in ESSPRI
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDDY391B12201
- 2025 (미국 NIH 보조금/계약: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524513-92-00 (기타 식별자: EU CTIS)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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