A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
A Phase 1, First-in-Human, Single Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of ABBV-519 in Subjects With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity.
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA.
This is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: ABBVIE CALL CENTER
- 전화번호: 844-663-3742
- 이메일: abbvieclinicaltrials@abbvie.com
연구 장소
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California
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Los Angeles, California, 미국, 90095
- 빼는
- UCLA Health West Medical Campus /ID# 282811
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Tustin, California, 미국, 92780
- 모병
- Solace Research /ID# 279155
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Florida
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Greenacres City, Florida, 미국, 33467
- 모병
- Finlay Medical Research - Greenacres /ID# 278380
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Plantation, Florida, 미국, 33317
- 모병
- Discovery Health Research Center /ID# 279691
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Texas
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Red Oak, Texas, 미국, 75154
- 모병
- Epic Medical Research /ID# 279180
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Key Inclusion Criteria:
- Individuals between 18 and 75 years of age inclusive at the time of Screening.
- Minimum baseline B-cell count of 50 cells/mcL.
Inclusion Criteria for SLE Participants:
- Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria.
- Positive ANA ≥ 1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double-stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome antigen A (SSA).
- Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score of ≥ 4 (excluding anti-dsDNA and C3/C4). Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility.
- Participants must have an inadequate response to ≥ 1 immunosuppressant therapies, used for at least 3 months.
Inclusion Criteria for RA Participants:
- Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA.
- Presence of rheumatoid factor (RF) or anti-citrullinated peptide antibodies (ACPA) above the ULN.
- Presence of at least 6 swollen and 6 tender joints
- High-sensitivity C-reactive protein (hs-CRP) ≥ 3 mg/L.
- Failed at least 1 conventional synthetic disease-modifying antirheumatic drug (DMARD) and ≥ 1 biological or targeted DMARDs of different classes.
Exclusion Criteria:
Key Exclusion Criteria:
- Participants with a history of infection.
- Participants with uncontrolled hypertension
Exclusion for SLE Participants:
Active neuropsychiatric SLE, or signs or symptoms of neuropsychiatric SLE within the 6 months prior to Screening (lupus headache permissible).
- Unstable or progressive glomerulonephritis (active class III or IV).
- SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease.
Exclusion for RA Participants:
-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Group 1: Dose A
Participants will receive a single intravenous (IV) dose of ABBV-519
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Intravenous (IV) Infusion
Subcutaneous (SC) Injection
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실험적: Group 2: Dose B
Participants will receive a single intravenous (IV) dose of ABBV-519
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Intravenous (IV) Infusion
Subcutaneous (SC) Injection
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실험적: Group 3: Dose C
Participants will receive a single intravenous (IV) dose of ABBV-519
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Intravenous (IV) Infusion
Subcutaneous (SC) Injection
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실험적: Group 4: Dose D
Participants will receive a single subcutaneous (SC) dose of ABBV-519
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Intravenous (IV) Infusion
Subcutaneous (SC) Injection
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실험적: Group 5: Dose E
Participants will receive a single subcutaneous (SC) dose of ABBV-519
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Intravenous (IV) Infusion
Subcutaneous (SC) Injection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from Baseline in B Cells in Blood
기간: Up to 365 Days
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Change from baseline in B cells in blood.
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Up to 365 Days
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Maximum Plasma Concentration (Cmax) of ABBV-519.
기간: Up to 85 Days
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Cmax of ABBV-519
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Up to 85 Days
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Time to Cmax (Tmax) of ABBV-519
기간: Up to 85 Days
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Tmax of ABBV-519
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Up to 85 Days
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Terminal Phase Elimination Half-Life (t1/2) of ABBV-519
기간: Up to 85 Days
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t1/2 of ABBV-519
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Up to 85 Days
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Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519
기간: Up to 85 Days
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AUCt of ABBV-519
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Up to 85 Days
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Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519
기간: Up to 169 Days
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Percentage of participants with detection of ADAs for ABBV-519
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Up to 169 Days
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Number of Participants with Adverse Events (AEs)
기간: Up to 425 Days
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An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
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Up to 425 Days
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: ABBVIE INC., AbbVie
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
- M25-989
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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류마티스 관절염에 대한 임상 시험
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Azienda Unita Sanitaria Locale di PiacenzaUniversity of Parma모병특발성 폐 섬유증(IPF) | 전신 질환으로 인한 간질성 폐질환(장애) | Reumatoid Arthritis | 결합 조직 질환 (CTD)체코, 이탈리아
ABBV-519에 대한 임상 시험
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Chong Kun Dang Pharmaceutical완전한
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Chong Kun Dang Pharmaceutical완전한
-
Chong Kun Dang Pharmaceutical완전한
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AbbVie종료됨낭포성 섬유증(CF)미국, 호주, 벨기에, 헝가리, 네덜란드, 뉴질랜드, 슬로바키아
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AbbVie완전한낭포성 섬유증미국, 벨기에, 캐나다, 체코, 프랑스, 헝가리, 네덜란드, 뉴질랜드, 폴란드, 슬로바키아, 영국, 세르비아