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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：ABBVIE CALL CENTER
- 電話番号：844-663-3742
- メール：abbvieclinicaltrials@abbvie.com
研究場所
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Alabama
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Anniston、Alabama、アメリカ、36207
- 募集
- Pinnacle Research Group /ID# 278677
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California
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Tustin、California、アメリカ、92780
- 募集
- Solace Research /ID# 279155
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Florida
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Clearwater、Florida、アメリカ、33765
- 募集
- Clinical Research Of West Florida - Phase I Unit /ID# 279292
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Greenacres City、Florida、アメリカ、33467
- 募集
- Finlay Medical Research - Greenacres /ID# 278380
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Kissimmee、Florida、アメリカ、34741
- 募集
- Clinical Research of Osceola /ID# 278374
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Plantation、Florida、アメリカ、33317
- 募集
- Discovery Health Research Center /ID# 279691
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Tampa、Florida、アメリカ、33606
- 募集
- Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130
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Illinois
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Orland Park、Illinois、アメリカ、60462
- 募集
- Advanced Quality Medical Research /ID# 279147
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Texas
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Red Oak、Texas、アメリカ、75154
- 募集
- Epic Medical Research /ID# 279180
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Tokyo
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Bunkyo-ku、Tokyo、日本、113-8519
- 募集
- Institute of Science Tokyo Hospital /ID# 279648
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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実験的：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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実験的：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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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in B Cells in Blood
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディディレクター：ABBVIE INC.、AbbVie
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- M25-989
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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