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쇼그렌 증후군 환자의 두 집단에서 CFZ533 다회 투여의 안전성 및 효능 연구 (TWINSS)

2026년 4월 23일 업데이트: Novartis Pharmaceuticals

쇼그렌 증후군(TWINSS) 환자의 두 집단에서 피하 투여된 다중 CFZ533 용량의 안전성과 효능을 평가하기 위한 48주, 6군, 무작위, 이중 맹검, 위약 대조 다기관 시험

이 연구는 쇼그렌 증후군 환자를 대상으로 다중 용량의 CFZ533(iscalimab)의 안전성, 효능, 약동학(PK) 및 약력학(PD)을 평가합니다.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

이것은 쇼그렌 증후군 환자의 2가지 개별 모집단(코호트)에서 CFZ533에 대한 이중 맹검, 무작위, 위약 대조, 다기관 연구입니다. 2) 전신 침범은 낮으나 증상부담은 높다.

이 연구에는 최대 6주의 스크리닝 기간, 48주의 치료(각각 24주의 치료 기간으로 구분) 및 12주 추적이 포함됩니다. 연구 치료제는 격주로 피하 주사로 투여될 것입니다.

연구 유형

중재적

등록 (실제)

273

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 그리스
      • Athens, 그리스, 115 27
        • Novartis Investigative Site
  • 네덜란드
      • Groningen, 네덜란드, 9713 GZ
        • Novartis Investigative Site
    • South Holland
      • Rotterdam, South Holland, 네덜란드, 3015 GD
        • Novartis Investigative Site
  • 대한민국
    • Seocho Gu
      • Seoul, Seocho Gu, 대한민국, 06591
        • Novartis Investigative Site
  • 독일
      • Bonn, 독일, 53105
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, 독일, 79106
        • Novartis Investigative Site
    • Bavaria
      • Würzburg, Bavaria, 독일, 97080
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, 독일, 01307
        • Novartis Investigative Site
  • 러시아 제국
      • Kazan', 러시아 제국, 420097
        • Novartis Investigative Site
      • Moscow, 러시아 제국, 115522
        • Novartis Investigative Site
      • Orenburg, 러시아 제국, 460000
        • Novartis Investigative Site
      • Saint Petersburg, 러시아 제국, 195257
        • Novartis Investigative Site
      • Tomsk, 러시아 제국, 634009
        • Novartis Investigative Site
      • Yekaterinburg, 러시아 제국, 620028
        • Novartis Investigative Site
  • 루마니아
      • Brasov, 루마니아, 500283
        • Novartis Investigative Site
      • Cluj-Napoca, 루마니아, 400006
        • Novartis Investigative Site
  • 미국
    • Georgia
      • Suwanee, Georgia, 미국, 30024
        • North GA Rheumatology Group PC
    • Indiana
      • Indianapolis, Indiana, 미국, 46202
        • Indiana Univ School of Dentistry
    • Louisiana
      • Baton Rouge, Louisiana, 미국, 70809
        • Ochsner Health System
    • Maryland
      • Baltimore, Maryland, 미국, 21224
        • The John Hopkins Jerome L Greene Sjogren
    • Massachusetts
      • Boston, Massachusetts, 미국, 02111
        • Tufts School of Dental Medicine
    • New York
      • Mineola, New York, 미국, 11501
        • Winthrop University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • Perelman School of Medicine
    • Wisconsin
      • Madison, Wisconsin, 미국, 53792
        • Uni Wisconsin School Med Pub Health
  • 브라질
    • Espírito Santo
      • Vitória, Espírito Santo, 브라질, 29055 450
        • Novartis Investigative Site
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, 브라질, 36010 570
        • Novartis Investigative Site
    • São Paulo
      • São Paulo, São Paulo, 브라질, 01244-030
        • Novartis Investigative Site
  • 스웨덴
    • SE
      • Stockholm, SE, 스웨덴, 113 65
        • Novartis Investigative Site
  • 아르헨티나
      • Buenos Aires, 아르헨티나, C1055AAF
        • Novartis Investigative Site
      • CABA, 아르헨티나, 1426
        • Novartis Investigative Site
  • 영국
      • Birmingham, 영국, B15 2TH
        • Novartis Investigative Site
      • Doncaster, 영국, DN2 5LT
        • Novartis Investigative Site
      • Manchester, 영국, M13 9WL
        • Novartis Investigative Site
  • 오스트리아
      • Graz, 오스트리아, 8036
        • Novartis Investigative Site
      • Vienna, 오스트리아, 1090
        • Novartis Investigative Site
  • 이스라엘
      • Haifa, 이스라엘, 3104802
        • Novartis Investigative Site
      • Kfar Saba, 이스라엘, 4428164
        • Novartis Investigative Site
      • Ramat Gan, 이스라엘, 5265601
        • Novartis Investigative Site
  • 이탈리아
    • MI
      • Milan, MI, 이탈리아, 20132
        • Novartis Investigative Site
    • PI
      • Pisa, PI, 이탈리아, 56126
        • Novartis Investigative Site
    • UD
      • Udine, UD, 이탈리아, 33100
        • Novartis Investigative Site
  • 일본
    • Aichi-ken
      • Nagoya, Aichi-ken, 일본, 457 8510
        • Novartis Investigative Site
    • Nagasaki
      • Sasebo, Nagasaki, 일본, 857-1195
        • Novartis Investigative Site
    • Okayama-ken
      • Kurashiki, Okayama-ken, 일본, 710-0824
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku, Tokyo, 일본, 104 8560
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, 일본, 160 8582
        • Novartis Investigative Site
  • 칠레
      • Concepción, 칠레, 6740
        • Novartis Investigative Site
    • Los Ríos Region
      • Valdivia, Los Ríos Region, 칠레, 5110683
        • Novartis Investigative Site
    • RM
      • Santiago, RM, 칠레, 7500588
        • Novartis Investigative Site
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, 칠레, 7500571
        • Novartis Investigative Site
      • Santiago, Santiago Metropolitan, 칠레, 7500710
        • Novartis Investigative Site
  • 캐나다
    • Ontario
      • Toronto, Ontario, 캐나다, M5T 2S8
        • Novartis Investigative Site
    • Quebec
      • Rimouski, Quebec, 캐나다, G5L 5T1
        • Novartis Investigative Site
      • Trois-Rivières, Quebec, 캐나다, G9A 3Y2
        • Novartis Investigative Site
  • 콜롬비아
    • Antioquia
      • Medellín, Antioquia, 콜롬비아, 050001
        • Novartis Investigative Site
    • Atlántico
      • Barranquilla, Atlántico, 콜롬비아, 080002
        • Novartis Investigative Site
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, 콜롬비아, 760012
        • Novartis Investigative Site
  • 터키 (Türkiye)
    • Yenimahalle
      • Ankara, Yenimahalle, 터키 (Türkiye), 06500
        • Novartis Investigative Site
  • 포르투갈
      • Almada, 포르투갈, 2805-267
        • Novartis Investigative Site
      • Lisbon, 포르투갈, 1649-035
        • Novartis Investigative Site
      • Lisbon, 포르투갈, 1050-034
        • Novartis Investigative Site
      • Ponte de Lima, 포르투갈, 4990 041
        • Novartis Investigative Site
  • 프랑스
      • Brest, 프랑스, 29200
        • Novartis Investigative Site
      • Le Kremlin-Bicêtre, 프랑스, 94275
        • Novartis Investigative Site
      • Lille, 프랑스, 59037
        • Novartis Investigative Site
      • Paris, 프랑스, 75014
        • Novartis Investigative Site
      • Strasbourg, 프랑스, 67000
        • Novartis Investigative Site
  • 헝가리
      • Budapest, 헝가리, 1023
        • Novartis Investigative Site
      • Szeged, 헝가리, 6720
        • Novartis Investigative Site
    • Fejér
      • Székesfehérvár, Fejér, 헝가리, 8000
        • Novartis Investigative Site
  • 호주
    • Western Australia
      • Nedlands, Western Australia, 호주, 6009
        • Novartis Investigative Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 서명된 동의서
  • 18세 이상의 남성 또는 여성 환자
  • ACR/EULAR 2016 기준에 따른 쇼그렌 증후군의 분류(Shiboski et al 2017)
  • 항-Ro/SSA 항체에 대한 혈청양성
  • ≥ 0.1 mL/min의 자극된 전체 타액 유속

코호트 1에 특정한 포함 기준:

  • 사전 정의된 8개의 장기 영역 내 ESSDAI ≥ 5
  • ESSPRI 점수 ≥5

코호트 2에 특정한 포함 기준:

  • 코호트 1에 대한 포함 기준에 대해 득점된 8개 도메인 내 ESSDAI < 5
  • ESSPRI 피로 하위 점수 ≥ 5 또는 ESSPRI 건조 하위 점수 ≥ 5

제외 기준:

  • 다른 자가면역성 류마티스 질환이 주요 질환을 구성하는 쇼그렌 증후군 중첩 증후군
  • 다른 연구 약물의 사용
  • 프로토콜이 특별히 허용되지 않는 한 B 세포 고갈 요법, 아바타셉트 또는 기타 면역억제제의 사전 사용.
  • 용량 >10 mg/일의 스테로이드 사용.
  • 조절되지 않는 안구 주사(눈 부속기에 영향을 미침), 후안검염 또는 마이봄선 질환(이 기준은 코호트 2에 대해 고려되는 환자에게만 적용됨)
  • 전신 치료가 필요한 활동성 바이러스, 세균 또는 기타 감염
  • 무작위화 전 2개월 이내에 생백신/약독화 백신 수령.
  • B형 간염(HBV) 또는 C형 간염(HCV)에 의한 만성 감염.
  • 활동성 결핵(TB) 감염의 증거.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Cohort 1 / Arm A
3 weekly subcutaneous (s.c.) loading doses of iscalimab were 600 mg on Weeks 0, 1 and 2. From Week 2 and up to Week 46 (last dose), iscalimab was administered s.c. bi-weekly at 600 mg. To maintain blinding in Period 2, placebo was administered at Week 25.
의약품: CFZ533
생물학적
다른 이름들:
  • 이스칼리맙
실험적: Cohort 1 / Arm B
3 weekly subcutaneous (s.c.) loading doses of iscalimab were 600 mg on Week 0, and 300 mg on Week 1 and Week 2. From Week 2 and up to Week 46 (last dose), iscalimab was administered s.c. bi-weekly at 300 mg. To maintain blinding in Period 2, placebo was administered at Week 25.
의약품: CFZ533
생물학적
다른 이름들:
  • 이스칼리맙
실험적: Cohort 1 / Arm C
3 weekly subcutaneous (s.c.) loading doses of iscalimab were 600 mg on Week 0, and 150 mg on Week 1 and Week 2. From Week 2 and up to Week 46 (last dose), iscalimab was administered s.c. bi-weekly at 150 mg. To maintain blinding in Period 2, placebo was administered at Week 25.
의약품: CFZ533
생물학적
다른 이름들:
  • 이스칼리맙
위약 비교기: Cohort 1 / Arm D (Period 1)
Placebo treatment is administered subcutaneous (s.c.) weekly for the first 3 doses, then bi-weekly from Week 2 to Week 22 in Period 1.
다른: 위약
주사 용 액체 위약
실험적: Cohort 1 / Arm D1 (Period 2)
Period 2: 3 weekly subcutaneous (s.c.) loading doses of 600 mg iscalimab on Week 24, 25 and 26. After Week 26 and up to Week 46 (last dose), iscalimab was administered bi-weekly at 600 mg.
의약품: CFZ533
생물학적
다른 이름들:
  • 이스칼리맙
실험적: Cohort 2 / Arm E
3 weekly subcutaneous (s.c.) loading doses of iscalimab were 600 mg on Week 0, 1 and 2. From Week 2 and up to Week 46 (last dose), iscalimab was administered s.c. bi-weekly at 600 mg. To maintain blinding in Period 2, placebo was administered at Week 25.
의약품: CFZ533
생물학적
다른 이름들:
  • 이스칼리맙
위약 비교기: Cohort 2 / Arm F (Period 1)
Placebo treatment was administered subcutaneous (s.c.) weekly for the first 3 doses, then bi-weekly from Week 2 to Week 22 in Period 1.
다른: 위약
주사 용 액체 위약
실험적: Cohort 2 / Arm F1 (Period 2)
Period 2: 3 weekly subcutaneous (s.c.) loading doses of iscalimab: 600 mg on Week 24, and 300 mg on Week 25 and Week 26. After Week 26, iscalimab was administered s.c. bi-weekly at 300 mg.
의약품: CFZ533
생물학적
다른 이름들:
  • 이스칼리맙

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Cohort 1: Change in EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) Score From Baseline at 24 Weeks as Compared to Placebo
기간: Baseline, Week 24
ESSDAI is a validated disease outcome measure for SjS that contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The domains (weights) are as follows: constitutional (3), lymphadenopathy (4), glandular (2), articular (2), cutaneous (3), pulmonary (5), renal (5), muscular (6), peripheral nervous system (PNS) (5), central nervous system (CNS) (5), hematological (2) and biological (1). The total score may vary between 0-123. It is considered low activity an ESSDAI < 5; moderate activity 5-13, and high activity if ESSDAI is >= 14.
Baseline, Week 24
Cohort 2: Change in EULAR Sjögren Syndrome Patient Reported Index (ESSPRI) Score From Baseline at 24 Weeks as Compared to Placebo.
기간: Baseline, Week 24
The ESSPRI is a self-evaluation index for measuring symptoms including pain, fatigue and dryness. Each symptom was measured with a single 0 (no symptoms) to 10 (severe symptoms) numerical scale and the final ESSPRI score is calculated by averaging these domains with a maximum severity score of 10.
Baseline, Week 24

2차 결과 측정

결과 측정
측정값 설명
기간
Cohort 1: Change From Baseline in ESSPRI at Week 24
기간: Baseline, Week 24
The ESSPRI is a self-evaluation index for measuring symptoms including pain, fatigue and dryness. Each symptom was measured with a single 0 (no symptoms) to 10 (severe symptoms) numerical scale and the final ESSPRI score is calculated by averaging these domains with a maximum severity score of 10.
Baseline, Week 24
Cohort 1: Change From Baseline in Score of Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Questionnaire at Week 24
기간: Baseline, 24 weeks
The FACIT F (Functional Assessment of Chronic Illness Therapy-Fatigue) is a validated 13 item patient reported outcome measure assessing fatigue and its impact on daily functioning over the past 7 days, with total scores ranging from 0 to 52, where higher scores indicate less fatigue.
Baseline, 24 weeks
Cohort 1: Change From Baseline in Physician Global Assessment (PhGA) at Week 24
기간: Baseline, 24 weeks
Physician's global assessment (PhGA) of disease activity was performed using a Visual Analog Scale (VAS) - an unnumbered 100 mm horizontal line ranging from "no disease activity" (score 0) to "maximal disease activity" (score 100). The assessment of patient's condition on the day is made by placing a vertical mark across the line.
Baseline, 24 weeks
Cohort 2: Change From Baseline in Score of Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Questionnaire at Week 24
기간: Baseline, 24 weeks
The FACIT F (Functional Assessment of Chronic Illness Therapy-Fatigue) is a validated 13 item patient reported outcome measure assessing fatigue and its impact on daily functioning over the past 7 days, with total scores ranging from 0 to 52, where higher scores indicate less fatigue.
Baseline, 24 weeks
Cohort 2: Change From Baseline in Physician Global Assessment (PhGA) at Week 24
기간: Baseline, 24 weeks
Physician's global assessment (PhGA) of disease activity was performed using a Visual Analog Scale (VAS) - an unnumbered 100 mm horizontal line ranging from "no disease activity" (score 0) to "maximal disease activity" (score 100). The assessment of patient's condition on the day is made by placing a vertical mark across the line.
Baseline, 24 weeks
Cohort 2: Change From Baseline in ESSDAI at Week 24
기간: Baseline, week 24
ESSDAI is a validated disease outcome measure for SjS that contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The domains (weights) are as follows: constitutional (3), lymphadenopathy (4), glandular (2), articular (2), cutaneous (3), pulmonary (5), renal (5), muscular (6), peripheral nervous system (PNS) (5), central nervous system (CNS) (5), hematological (2) and biological (1). The final score may vary between 0-123. It is considered low activity an ESSDAI < 5; moderate activity 5-13, and high activity if ESSDAI is >= 14.
Baseline, week 24
Cohort 2: Proportion of Subjects With at Least 12 Points Improvement Measured by Score of Impact of Dry Eye on Everyday Life (IDEEL) Questionnaire Symptom Bother Module at Week 24.
기간: Baseline, Week 24

The Impact of Dry Eye on Everyday Life (IDEEL) questionnaire is a comprehensive dry eye specific questionnaire to evaluate treatment satisfaction, symptom-related bother and impact on daily life in a population with dry eye. This study only utilized the Dry Eye Symptom-Bother module.

The Dry Eye Symptom-Bother module of IDEEL is composed of a single dimension (20 items). A 4-point Likert-like scale is used: from "not at all" to "very much". Patients could also answer "I did not have this symptom / Not applicable". One item is scored on a 5-point Likert-like scale from "none of the time" to "all of the time". The range for the symptom-bother score is 0 to 100, with higher scores indicating greater symptom bother.
Baseline, Week 24
Cohort 1: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) up to Week 24
기간: Up to Week 24

The distribution of adverse events in Treatment Period 1 was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

Analyses of data in the Safety Set (SAF) up to Week 24 (Period 1) is presented by actual treatment during Period 1, with data from separate cohort for the CFZ533 600mg and for the Placebo groups: CFZ533 600 mg, CFZ533 300 mg, CFZ533 150 mg and placebo.
Up to Week 24
Cohort 1: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) in All Study Periods
기간: up to 14 weeks following the last dose of study treatment, up to maximum Week 60

The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

Analyses of data in the Safety Set (SAF) for period 2/3 or overall study is presented by actual treatment sequence during periods 1 and 2, where the CFZ533 600 mg - CFZ533 600 mg sequence included data from patients in separate cohort. CFZ533 600 mg 24 Weeks arm includes only patients from Placebo - CFZ533 600 mg arm, who took at least one CFZ533 600 mg dose in Period 2 (Patients who received Placebo in Period 1 and discontinued before Week 24 are not included). CFZ533 600 mg 48 Weeks arm includes all subjects from CFZ533 600 mg - CFZ533 600 mg arm, and subjects from CFZ533 150 mg - CFZ533 150 mg and CFZ533 300 mg - CFZ533 300 mg arms but only took the first or the first two loading dose(s) in period 1.
up to 14 weeks following the last dose of study treatment, up to maximum Week 60
Cohort 2: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) up to Week 24
기간: Up to Week 24

The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

Analyses of data in the Safety Set (SAF) up to Week 24 (Period 1) is presented by actual treatment during Period 1, with data from separate cohort for the CFZ533 600mg and for the Placebo groups: CFZ533 600 mg and placebo.
Up to Week 24
Cohort 2: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) in All Study Periods
기간: up to 14 weeks following the last dose of study treatment, up to maximum Week 60

The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

Analyses of data in the Safety Set (SAF) for period 2/3 or overall study is presented by actual treatment sequence during periods 1 and 2, where the CFZ533 600 mg - CFZ533 600 mg sequence included data from patients in separate cohort. CFZ533 300 mg 24 Weeks includes only patients from Placebo - CFZ533 300 mg arm, who received Placebo in Period 1, and either took CFZ533 600 mg loading dose + at least two CFZ533 300 mg subsequent doses in Period 2 or missed CFZ533 600 mg loading dose and took at least one CFZ533 300 mg dose in Period 2 (Patients who received Placebo in Period 1 and discontinued before Week24 are not included). CFZ533 600 mg 48 Weeks arm includes all subjects from CFZ533 600 mg - CFZ533 600 mg arm.
up to 14 weeks following the last dose of study treatment, up to maximum Week 60
Cohort 1: Change From Baseline in Serum Free Light Kappa (FLCκ) Chains Levels
기간: Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 40, Week 48 (End Treatment Period 2), FUP2 (Week 56), FUP 3 (Week 60)
Serum samples for free light kappa (FLCκ) chains were collected and analyzed.
Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 40, Week 48 (End Treatment Period 2), FUP2 (Week 56), FUP 3 (Week 60)
Cohort 2: Change From Baseline in Serum Free Light Kappa (FLCκ) Chains Levels
기간: Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 40, Week 48 (End Treatment Period 2), FUP2 (Week 56), FUP 3 (Week 60)
Serum samples for free light kappa (FLCκ) chains were collected and analyzed.
Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 40, Week 48 (End Treatment Period 2), FUP2 (Week 56), FUP 3 (Week 60)
Cohort 1: Change From Baseline in Immunoglobulin G (IgG) Levels
기간: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Plasma samples for Immunoglobulin G (IgG) were collected and analyzed.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Cohort 2: Change From Baseline in Immunoglobulin G (IgG) Levels
기간: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Plasma samples for Immunoglobulin G (IgG) were collected and analyzed.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Cohort 1: Change From Baseline in Immunoglobulin M (IgM) Levels
기간: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Plasma samples for Immunoglobulin M (IgM) were collected and analyzed.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Cohort 2: Change From Baseline in Immunoglobulin M (IgM) Levels
기간: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Plasma samples for Immunoglobulin M (IgM) were collected and analyzed.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (End Treatment Period 1), Week 28, Week 32, Week 40, Week 48 (End Treatment Period 2), FUP1 (Week 52), FUP2 (Week 56), FUP 3 (Week 60)
Cohort 1: Change From Baseline in Plasma CXCL-13 Levels
기간: Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 48 (End Treatment Period 2), FUP 3 (Week 60)
Plasma samples for Chemokine (C-X-C motif) ligand 13 (CXCL13), also known as B lymphocyte chemoattractant (BLC) or B cell-attracting chemokine 1 (BCA-1) were collected and analyzed.
Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 48 (End Treatment Period 2), FUP 3 (Week 60)
Cohort 2: Change From Baseline in Plasma CXCL-13 Levels
기간: Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 48 (End Treatment Period 2), FUP 3 (Week 60)
Plasma samples for Chemokine (C-X-C motif) ligand 13 (CXCL13), also known as B lymphocyte chemoattractant (BLC) or B cell-attracting chemokine 1 (BCA-1) were collected and analyzed.
Baseline, Week 4, Week 12, Week 24 (End Treatment Period 1), Week 32, Week 48 (End Treatment Period 2), FUP 3 (Week 60)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

수사관

  • 연구 책임자: Study Director Novartis Pharmaceuticals, Novartis Pharmaceuticals

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 10월 1일

기본 완료 (실제)

2022년 9월 28일

연구 완료 (실제)

2023년 6월 6일

연구 등록 날짜

최초 제출

2019년 3월 25일

QC 기준을 충족하는 최초 제출

2019년 4월 4일

처음 게시됨 (실제)

2019년 4월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 23일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CCFZ533B2201
  • 2018-004476-35 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Novartis는 환자 수준 데이터에 대한 액세스를 공유하고 적격한 외부 연구원과 적격한 연구의 임상 문서를 지원하기 위해 최선을 다하고 있습니다. 요청은 과학적 가치에 따라 독립적인 검토 패널에서 검토하고 승인합니다. 제공된 모든 데이터는 해당 법률 및 규정에 따라 임상시험에 참여한 환자의 개인 정보를 보호하기 위해 익명으로 처리됩니다.

이 시험 데이터 가용성은 www.clinicalstudydatarequest.com에 설명된 기준 및 프로세스에 따릅니다.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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