A Study to Evaluate the Safety and Efficacy (How Well the Study Treatment Works) of ABBV-2294 in Adult Participants With Systemic Sclerosis That Are Currently Receiving Local Standard of Care Treatment, and to Determine the Best Dose of ABBV-2294 to be Evaluated Further.
A Phase 2b/3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABBV-2294 (Combination of ABBV-722 and Upadacitinib) in Adult Patients With Systemic Sclerosis
Systemic sclerosis (SSc), also called scleroderma, is a rare long-term autoimmune disease that causes the body to make too much collagen (scar tissue), leading to hard, thick skin and sometimes damage to organs such as the lungs, heart, kidneys, or digestive system. An autoimmune disease is a condition where the body's immune system, which normally protects against germs, mistakenly attacks its own healthy tissues and organs.
The study has 2 parts. The main goal of Part 1 is to evaluate the safety and efficacy (how well the study treatment works) of ABBV-2294 (combination of ABBV-722 and upadacitinib) in adult participants with SSc that are currently receiving local standard of care treatment, and to determine the best dose of ABBV-2294 to be evaluated further. The main goal of Part 2 is to evaluate the safety and efficacy of the dose of ABBV-2294 determined in Part 1 when compared to placebo (looks like the study treatment but has no medicine in it) in adult patients with SSc that are currently receiving local standard of care treatment. Participants will undergo trial-related procedures throughout the study which may include physical exams, questionnaires, scans and imaging, and blood and urine tests.
ABBV-2294 (combination of ABBV-722 and upadacitinib) is an investigational drug being developed for the treatment of SSc in adult participants. At the start of Part 1, participants will be randomly assigned to receive Dose 1 of ABBV-722 and upadacitinib given together, Dose 2 of ABBV-722 and upadacitinib given together, ABBV-722 given alone, upadacitinib given alone, or placebo for 52 weeks. Participants that complete 52 weeks of treatment will be invited to join a 56-week extension period.
Participants that join Part 2 will be randomly assigned to receive either ABBV-2294 (dose determined in Part 1) or placebo for 52 weeks. Participants that complete 52 weeks of treatment will be invited to join a 104-week extension period. All participants that join the extension will receive ABBV-2294.
Participants 18 years of age and older diagnosed with Systemic sclerosis (SSc). Around 580 participants will be enrolled at approximately 200 sites worldwide.
Participants will receive upadacitinib and/or ABBV-722 oral tablets (or matching placebo) for 52 weeks in Part 1 with an optional 56-week extension period. Part 2 participants will receive ABBV-2294 (dose determined in Part 1) or matching placebo for 52 weeks with an optional 104-week extension period of open label ABBV-2294 (dose determined in Part 1).
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, including screening, baseline, and scheduled visits. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究連絡先
研究連絡先
- 名前：ABBVIE CALL CENTER
- 電話番号：844-663-3742
- メール：abbvieclinicaltrials@abbvie.com
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Participants must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any Screening or study-specific procedures.
- Adults >= 18 years of age at the time of the Screening Visit (subjects must also meet the legal age of majority per local law).
- Participants are willing and able to comply with procedures required in the protocol.
- Participants must not be incarcerated and must be freely willing and able to provide informed consent. Examples of subjects unable to freely provide informed consent may include some adults under legal protection measure (e.g., under guardianship/curatorship) or unable to express their consent and select adults under psychiatric care. Investigator's discretion should be applied.
- Participants must fulfil the ACR/EULAR 2013 classification criteria for SSc
Exclusion Criteria:
- Other autoimmune connective tissue diseases, overlap syndromes, or SSc mimics (e.g., scleromyxedema, eosinophilic fasciitis), except scleroderma-associated myopathy and associated Sjögren disease.
- Pulmonary disease with predicted FVC < 45% at Screening.
- Predicted diffusing capacity for carbon monoxide (DLCO, Hb corrected) < 25% at Screening.
- History of scleroderma renal crisis within the last 6 months.
- History of severe gastric antral telangiectasias (watermelon stomach).
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Part 1: Double Blind Placebo Controlled Arm 1
Participants are randomized to receive Dose 1: ABBV-2294 (combination of ABBV-722 and upadacitinib) |
Oral Tablet Oral Tablet |
|
実験的：Part 1: Double Blind Placebo Controlled Arm 2
Participants are randomized to receive Dose 2: ABBV-2294 (combination of ABBV-722 and upadacitinib) |
Oral Tablet Oral Tablet |
|
実験的：Part 1: Double Blind Placebo Controlled Arm 3
Participants are randomized to receive ABBV-722 |
Oral Tablet |
|
実験的：Part 1: Double Blind Placebo Controlled Arm 4
Participants are randomized to receive upadacitinib |
Oral Tablet |
|
実験的：Part 1: Double Blind Placebo Controlled Arm 5
Participants are randomized to receive placebo |
Oral Tablet Oral Tablet |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Part 1 & Part 2: Achievement of Revised Composite Response Index in Systemic Sclerosis (rCRISS)-25
時間枠：At Week 52
|
The rCRISS is a 2-step process wherein participants are determined to be considered as a responder or a non-responder. The first step of the rCRISS accounts for worsening or incident cases of any internal organ involvement. If the participant meets any of the Step 1 criteria, they are considered a non-responder in the trial afterwards. Step 2 includes 5 core set measures. The FVC% is evaluated to see if the change is at least 5%. The other 4 core set measures (modified Rodnan skin score (mRSS), Health Assessment Questionnaire Disability Index (HAQ-DI), Patient Global Assessment (PGA) and clinician global assessment) are evaluated for change of at least 25%. A responder is a participant who has relative improvement on at least 2 of the 5 core set measures without worsening on more than 1 core set measure |
At Week 52
|
|
Part 1 & Part 2: Number of Participants Experiencing Adverse Events
時間枠：Up to 112 Weeks
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Up to 112 Weeks
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Part 1 & Part 2: Change from Baseline in Forced Vital Capacity (FVC) (mLs) in participants with interstitial lung disease (ILD) at Baseline
時間枠：At Week 52
|
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity. |
At Week 52
|
|
Part 1 & Part 2: Absolute change from Baseline in percent-predicted FVC in subjects with ILD at Baseline
時間枠：At Week 52
|
FVC is a test that measures the total amount of air a person can fully exhale from their lungs after a deep inhalation. A low FVC can demonstrate reduced lung capacity. |
At Week 52
|
|
Part 1 & Part 2: Change from Baseline in modified Rodnan skin score (mRSS) in all participants with mRSS score of > 10 at Baseline
時間枠：At Week 52
|
The mRSS is a clinical assessment tool used to evaluate skin thickness in patients with SSc, a condition characterized by skin thickening and fibrosis. Skin thickness will be assessed by palpation and rated using an mRSS that ranges from 0 (normal) to 3 (severe skin thickening) across 17 different body sites. |
At Week 52
|
|
Part 1 & Part 2: Improvement from Baseline in each of the following 3 components of the rCRISS-25 evaluated separately: FVC , mRSS and Health Assessment Questionnaire Disability Index (HAQ-DI)
時間枠：At Week 52
|
|
At Week 52
|
|
Part 1 & Part 2: Change from Baseline in joint pain as assessed by the SSc Daily Diary
時間枠：At Week 52
|
At Week 52
|
|
|
Part 1 & Part 2: Change from Baseline in the Scleroderma Skin Patient Reported Outcome (SSPRO) physical effects domain
時間枠：At Week 52
|
At Week 52
|
|
|
Part 1 & Part 2: Change from Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
時間枠：At Week 52
|
The HAQ DI is a questionnaire that determines physical function. |
At Week 52
|
|
Part 1 & Part 2: Improvement from Baseline in each of the following 2 components of the rCRISS-25 evaluated separately: PGA and CGA
時間枠：At Week 52
|
|
At Week 52
|
|
Part 1 & Part 2: Absolute change from Baseline in percent-predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) (corrected for hemoglobin [Hb]) in participants with interstitial lung disease (ILD) at Baseline
時間枠：At Week 52
|
At Week 52
|
協力者と研究者
捜査官
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 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- M25-153
- 2026-525967-42-00 (Ctis)
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?
IPD プランの説明
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD 共有時間枠
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 共有アクセス基準
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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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