クローン病または潰瘍性大腸炎患者におけるバリナツンフィブの長期安全性、耐容性および有効性を検討する試験（SPECIFI-IBD-LTS）
バリナツンフィブのクローン病または潰瘍性大腸炎を有する成人における長期安全性、忍容性および有効性を調査する多国籍・多施設共同延長試験
LTS19689 is a multinational, multicenter extension study to evaluate the long-term safety, tolerability and efficacy of balinatunfib in participants with Crohn's disease (CD) or ulcerative colitis (UC) who completed the 52-week treatment period (on balinatunfib or placebo) in the parent studies, SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822), respectively.
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The primary objective of this study is to assess the long-term safety and tolerability of different doses of balinatunfib in participants with CD or UC, as measured by the number and percentage of participants with CD or UC with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) during the study period.
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The study will consist of 2 independent cohorts through the study given the distinct nature of each disease:
- CD Cohort: comprised of CD participants enrolled from SPECIFI-CD (DRI18212).
- UC Cohort: comprised of UC participants enrolled from SPECIFI-UC (DRI17822).
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The study will consist of the following study periods for each cohort:
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A Double-Blind (DB) treatment period of up to 104 weeks for eligible participants from the DB maintenance phases of the respective parent studies.
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An Open-Label (OL) treatment period of up to 104 weeks for:
- Eligible participants from either the DB or OL periods of the parent studies,
- Eligible participants who meet escape criteria at any time during the DB period of the LTS19689.
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A 2-week follow-up period following the End of Treatment (EOT). The study duration will be up to 107 weeks, with the treatment duration up to 104 weeks.
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調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Texas
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Southlake、Texas、アメリカ、76092
- Texas Digestive Disease Consultants - Southlake- Site Number : 8400005
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Buenos Aires、アルゼンチン、1061
- Investigational Site Number : 0320001
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Milano
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Milan、Milano、イタリア、20132
- Investigational Site Number : 3800002
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Olomouc、チェコ、779 00
- Investigational Site Number : 2030001
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Reg Metropolitana de Santiago
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Santiago、Reg Metropolitana de Santiago、チリ、8331143
- Investigational Site Number : 1520010
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Santiago、Reg Metropolitana de Santiago、チリ、7500010
- Investigational Site Number : 1520016
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Santiago、Reg Metropolitana de Santiago、チリ、8380456
- Investigational Site Number : 1520012
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Gorna Oryahovitsa、ブルガリア、5100
- Investigational Site Number : 1000001
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Guangzhou、中国、510080
- Investigational Site Number : 1560002
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Shanghai、中国、200120
- Investigational Site Number : 1560032
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参加基準
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 are eligible to be included in the study only if all of the following criteria apply:
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Participants with Crohn's Disease (CD) or ulcerative colitis (UC) who completed treatment at Week 52 of the SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822) studies, respectively:
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Participants with CD
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who complete double-blinded treatment at Week 52 of SPECIFI-CD (DRI18212) study;
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who complete open label treatment and achieve the appropriate outcomes at Week 52 of SPECIFI-CD (DRI18212) study.
OR
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Participants with UC
- who complete double-blinded treatment at Week 52 of SPECIFI-UC (DRI17822) study;
- who complete open label treatment and achieve the appropriate outcomes at Week 52 of the SPECIFI-UC (DRI17822) study.
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Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding
Exclusion Criteria:
- Participants with CD who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-CD (DRI18212) clinical trial protocol.
- Participants with UC who develop a new medical condition precluding participation as described in Exclusion criteria of SPECIFI-UC (DRI17822) clinical trial protocol.
- Participants who developed a new medical condition or a change in status of an established medical condition which (per Investigator's medical judgment) would adversely affect the participation in this study or would require permanent IMP discontinuation.
- Participants who permanently discontinued IMP during the parent study or temporarily discontinued IMP for more than 14 consecutive calendar days by the time of Day 1 of LTS19689.
- Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to balinatunfib, which in the opinion of the Investigator could indicate that continued treatment with balinatunfib may present an unreasonable risk for the participant.
- Participants who in the parent study had documented nonadherence to IMP or to standard therapies for CD or UC, or who used a prohibited medication concomitant with IMP or during a temporary IMP discontinuation period.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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：非ランダム化
- 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：CD cohort: balinatunfib dose regimen 1
Participants will receive balinatunfib dose regimen 1 |
Pharmaceutical form:Tablet -Route of administration:Oral
他の名前：
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実験的：CD cohort: balinatunfib dose regimen 2
Participants will receive balinatunfib dose regimen 2 |
Pharmaceutical form:Tablet -Route of administration:Oral
他の名前：
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実験的：CD cohort: balinatunfib dose regimen 3
Participants will receive balinatunfib dose regimen 3 |
Pharmaceutical form:Tablet -Route of administration:Oral
他の名前：
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プラセボコンパレーター：CD cohort: Placebo
Participants will receive balinatunfib-matching placebo |
Pharmaceutical form:Tablet -Route of administration:Oral |
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実験的：UC cohort: balinatunfib dose regimen 1
Participants will receive balinatunfib dose regimen 1 |
Pharmaceutical form:Tablet -Route of administration:Oral
他の名前：
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実験的：UC cohort: balinatunfib dose regimen 2
Participants will receive balinatunfib dose regimen 2 |
Pharmaceutical form:Tablet -Route of administration:Oral
他の名前：
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実験的：UC cohort: balinatunfib dose regimen 3
Participants will receive balinatunfib dose regimen 3 |
Pharmaceutical form:Tablet -Route of administration:Oral
他の名前：
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プラセボコンパレーター：UC cohort: Placebo
Participants will receive balinatunfib-matching placebo |
Pharmaceutical form:Tablet -Route of administration:Oral |
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 |
時間枠 |
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クローン病患者における治療発現性有害事象（TEAE）、重篤な有害事象（SAE）および特別関心有害事象（AESI）の参加者数
時間枠：研究終了時まで（約106週間）
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研究終了時まで（約106週間）
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潰瘍性大腸炎患者における治療 emergent 有害事象（TEAE）、重篤な有害事象（SAE）、および特別関心有害事象（AESI）を有する参加者数
時間枠：研究終了時まで（約106週間）
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研究終了時まで（約106週間）
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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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Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn's disease (SES-CD)
時間枠：Week 52
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Endoscopic remission is defined as SES-CD ≤4 points (SES CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD subscore >1 point from baseline. The SES-CD evaluates 4 endoscopic items (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. |
Week 52
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Proportion of participants with Crohn's Disease in endoscopic remission based on simple endoscopic score for Crohn's disease (SES-CD)
時間枠：Week 104
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Endoscopic remission is defined as SES-CD ≤4 points (SES CD ≤2 points for isolated ileal disease) and a SES-CD decrease ≥2 points with no SES-CD subscore >1 point from baseline. The SES-CD evaluates 4 endoscopic items (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. |
Week 104
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Proportion of participants with Crohn's Disease in clinical remission based on Crohn's disease activity index (CDAI)
時間枠：Week 52
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Clinical remission is defined as CDAI <150. The CDAI score is composed of eight items: 3 of them (abdominal pain, stool frequency and general well-being) completed by the participant and the others (use of anti-diarrheal medications, extraintestinal complications, palpable abdominal mass, hematocrit levels, and body weight) assessed and reported by the clinician. The CDAI is derived from summing up the weighted individual scores of eight items. Scores on the CDAI scale range from 0 to 600, with higher scores indicating more severe disease. |
Week 52
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Proportion of participants with Crohn's Disease in clinical remission based on Crohn's disease activity index (CDAI)
時間枠：Week 104
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Clinical remission is defined as CDAI <150. The CDAI score is composed of eight items: 3 of them (abdominal pain, stool frequency and general well-being) completed by the participant and the others (use of anti-diarrheal medications, extraintestinal complications, palpable abdominal mass, hematocrit levels, and body weight) assessed and reported by the clinician. The CDAI is derived from summing up the weighted individual scores of eight items. Scores on the CDAI scale range from 0 to 600, with higher scores indicating more severe disease. |
Week 104
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Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
時間枠：Week 52
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Clinical remission by modified Mayo score (mMS) is defined as a mMS score of 0 to 2, including stool frequency (SF) of 0 or 1, rectal bleeding (RB) subscore of 0, and centrally read modified Mayo Endoscopic Subscore [mMES] of 0 or 1 (score of 1 modified to exclude friability).Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity |
Week 52
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Proportion of participants with ulcerative colitis in clinical remission based on modified Mayo Score (mMS)
時間枠：Week 104
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Clinical remission by modified Mayo score (mMS) is defined as a mMS score of 0 to 2, including stool frequency (SF) of 0 or 1, rectal bleeding (RB) subscore of 0, and centrally read modified Mayo Endoscopic Subscore [mMES] of 0 or 1 (score of 1 modified to exclude friability).Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity |
Week 104
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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
その他の研究ID番号
- LTS19689
- 2025-522511-42 (レジストリ識別子：CTIS)
- U1111-1321-1765 (レジストリ識別子：WHO ICTRP)
- 2025 (米国 NIH グラント/契約)
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
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。