BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
2019年9月25日 更新者：AbbVie
BI 655066 / ABBV-066 (Risankizumab) Versus Placebo In a Multicenter Randomized Double-blind Study in Patients With Moderate to Severe Chronic Plaque Psoriasis Evaluating the Efficacy and Safety With Randomized Withdrawal and Re-treatment (IMMhance)
This was a multinational, multicenter, randomized, double-blind, placebo controlled study with randomized withdrawal and retreatment, evaluating the safety and efficacy of risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque psoriasis.
調査の概要
詳細な説明
In Part A1, eligible participants were randomized at Baseline at a ratio of 4:1, stratified by weight and prior exposure to tumor necrosis factor antagonists to receive double-blind (DB) risankizumab 150 mg or placebo at Weeks 0 and 4. In Part A2, participants randomized at Baseline to receive DB placebo then received risankizumab 150 mg at Weeks 16 (Part A2) and at Week 28 and every 12 weeks up to 88 weeks (Part B); participants randomized to risankizumab 150 mg continued to receive risankizumab 150 mg at Week 16.
Participants who received risankizumab in Part A and were nonresponders (sPGA >2) at Week 28 received risankizumab 150 mg at Week 28 and every 12 weeks up to 88 weeks (Part B).
In Part B, participants who received risankizumab in Part A and were responders (sPGA ≤2) at Week 28, were rerandomized at a ratio of 1:2 to receive DB risankizumab 150 mg or placebo at Week 28 and every 12 weeks up to 88 weeks (Part B).
Starting at Week 32, rerandomized participants who reached relapse (defined as sPGA ≥3) were switched to risankizumab 150 mg every 12 weeks.
研究の種類
介入
入学 (実際)
507
段階
- フェーズ 3
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion criteria:
- Male or female participants. Woman of childbearing potential must be ready and willing to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1 percent per year when used consistently and correctly.
- Age ≥18 years at screening
- Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study drug. Duration of diagnosis may be reported by the participant.
- Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomization); Have an involved body surface area (BSA) ≥ 10% and Have a Psoriasis Area and Severity Index (PASI) ≥ 12 and Have a static Physician Global Assessment (sPGA) score of ≥ 3.
- Must be a candidate for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator
- Signed and dated written informed consent prior to admission to the study and performance of any study procedures in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion criteria:
- Participants with nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular); current drug-induced psoriasis (including a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium); active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to the investigators judgment.
- Previous exposure to ABBV-066
- Currently enrolled in another investigational study or less than 30 days (from screening) since completing another investigational study
- Use of any restricted medication as noted or any drug considered likely to interfere with the safe conduct of the study.
- Major surgery performed within 12 weeks prior to randomization or planned within 12 months after screening (e.g., hip replacement, removal aneurysm, stomach ligation).
- Known chronic or relevant acute infections such as active tuberculosis, human immunodeficiency virus (HIV), or viral hepatitis
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
- Evidence of a current or previous disease (including chronic alcohol or drug abuse), medical condition other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram [ECG]), or laboratory value at the screening visit outside the reference range that in the opinion of the Investigator, is clinically significant and would make the study participant unable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
- History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Previous enrolment in this trial
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：4倍
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：Risankizumab
Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1).
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Risankizumab administered by subcutaneous injection
他の名前：
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プラセボコンパレーター：Placebo
Participants randomized at Baseline to receive double-blind (DB) placebo by subcutaneous injection at Weeks 0 and 4 (Part A1).
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Placebo for risankizumab administered by subcutaneous 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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Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16
時間枠：Baseline, Week 16
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PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.
The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score.
The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
Non-responder imputation (NRI) was used for missing data.
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Baseline, Week 16
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Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16
時間枠：Week 16
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The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation.
Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe).
The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
NRI was used for missing data.
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Week 16
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Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52
時間枠：Week 52
|
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation.
Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe).
The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
NRI was used for missing data.
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Week 52
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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16週目にPASIスコア（PASI75）で75％の改善を達成した参加者の割合
時間枠：16週目
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PASIは、乾癬の体表面積への影響の程度と、検査当日に観察された病変の紅斑の拡大（発赤）、硬結（厚さ）、落屑（鱗屑）、および影響を受けた領域に基づく複合スコアです。
各徴候の重症度は、0=症状なし、1=軽度、2=中等度、3=顕著な、4=非常に顕著な5段階スケールを使用して評価されました。
PASI スコアは 0 ～ 72 の範囲で、0 は乾癬がないことを示し、72 は非常に重度の乾癬であることを示します。
PASI75 は、ベースライン PASI スコアと比較して、PASI スコアが少なくとも 75% 減少したものとして定義されます。
スコアの減少率は、(ベースラインでの PASI スコア - フォローアップ訪問でのスコア) / ベースラインでの PASI スコア * 100 として計算されます。
NRI は欠損データに使用されました。
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16週目
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Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16
時間枠：Week 16
|
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.
The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score.
The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
NRI was used for missing data.
|
Week 16
|
|
Percentage of Participants Achieving an sPGA Score of Clear at Week 16
時間枠：Week 16
|
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation.
Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe).
The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
NRI was used for missing data.
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Week 16
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Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
時間枠：Week 16
|
The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment).
Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3).
The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life.
The higher the score, the more the quality of life is impaired.
NRI was used for missing data.
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Week 16
|
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Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104
時間枠：Week 104
|
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation.
Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe).
The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5.
NRI was used for missing data.
|
Week 104
|
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Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52
時間枠：Week 52
|
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.
The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score.
The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
NRI was used for missing data.
|
Week 52
|
|
Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52
時間枠：Week 52
|
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.
The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score.
The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
NRI was used for missing data.
|
Week 52
|
|
Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52
時間枠：Week 52
|
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked.
The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.
PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score.
The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
NRI was used for missing data.
|
Week 52
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z.
- Lebwohl MG, Soliman AM, Yang H, Wang J, Hagan K, Padilla B, Pinter A. Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Feb;12(2):407-418. doi: 10.1007/s13555-021-00660-3. Epub 2021 Dec 18.
- Blauvelt A, Leonardi CL, Gooderham M, Papp KA, Philipp S, Wu JJ, Igarashi A, Flack M, Geng Z, Wu T, Camez A, Williams D, Langley RG. Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020 Jun 1;156(6):649-658. doi: 10.1001/jamadermatol.2020.0723.
- Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年2月29日
一次修了 (実際)
2017年8月2日
研究の完了 (実際)
2018年7月26日
試験登録日
最初に提出
2016年2月1日
QC基準を満たした最初の提出物
2016年2月1日
最初の投稿 (見積もり)
2016年2月3日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月9日
QC基準を満たした最後の更新が送信されました
2019年9月25日
最終確認日
2019年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- M15-992
- 2014-005102-38 (EudraCT番号)
- 1311.4 (その他の識別子：Boehringer Ingelheim)
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?
はい
IPD プランの説明
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor.
This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission.
This includes requests for clinical trial data for unlicensed products and indications.
IPD 共有時間枠
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD 共有アクセス基準
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
For more information on the process, or to submit a request, visit the following link.
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- 臨床試験報告書（CSR）
- 分析コード
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