רדאר קליני AI
הניסוי הקליני NCT03758443 (RHEA) עבור קוליטיס כיבית (UC) הוא הופסק. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים

Efficacy & Safety of TD-1473 in Ulcerative Colitis (RHEA) שלב II, שלב III 239

הופסק
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
ניסוי קליני NCT03758443 (RHEA) מתקיים כדי לבדוק את טיפול עבור קוליטיס כיבית (UC). זהו מחקר שלב II שלב III מסוג התערבותי שנמצא כעת במצב הופסק. המחקר התחיל ב-11 במרץ 2019 ומתוכנן לכלול 239 משתתפים. המחקר מנוהל על ידי תרבנס ביופארמה וצפוי להסתיים ב-20 באוקטובר 2021. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-15 בנובמבר 2022.
סיכום קצר
A Phase 2b/3 set of studies to evaluate the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.
תיאור מפורט
This protocol consists of 3 separate studies: an 8-week Phase 2b dose-finding induction study, an 8-week dose-confirming Phase 3 induction study, and a 44-week Phase 3 maintenance study. Subjects who respond to induction will enter the maintenance study; those who do not will receive TD-1473 during extended induction. The safety and efficacy data of the Phase 2b study will be analyzed to select the induction and main...הצג עוד
כותרת רשמית

A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis

מצבים רפואיים
קוליטיס כיבית (UC)
מזהי מחקר נוספים
  • RHEA
  • 0157
  • 2018-002136-24 (מספר EudraCT)
מספר NCT
תחילת המחקר (בפועל)
2019-03-11
עדכון אחרון שפורסם
2022-11-15
סיום המחקר (מוערך)
2021-10-20
משתתפים (מתוכנן)
239
סוג המחקר
התערבותי
שלב
שלב II
שלב III
סטטוס
הופסק
מילות מפתח
TD-1473
Janus kinase inhibitor
JAK inhibitor
Inflammatory Bowel Disease
IBD
Ulcerative colitis
UC
Gut selective
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
מרובע
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
ניסיActive Treatment TD-1473 Dose A
Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.
TD-1473 Dose A
See Arm description
ניסיActive Treatment TD-1473 Dose B
Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.
TD-1473 Dose B
See Arm description
ניסיActive Treatment TD-1473 Dose C
Participants will be randomized to receive an oral daily dose of TD-1473. Responders will be re-randomized into the Phase 3 Maintenance portion of the study. Non-responders may participate in an extended induction.
TD-1473 Dose C
See Arm description
פלצבו להשוואהPlacebo
Participants will be randomized to receive an oral daily dose of placebo. Participants who received Placebo (and were non-responders) may move to an extended induction. Subjects who are on placebo will be assigned to active TD-1473 for the extended induction (they will be blinded to dose).
פלצבו
See Arm description
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
Change From Baseline in Total Mayo Score (tMS) at Week 8
Total Mayo Score (tMS) was calculated as the sum of four components: rectal bleeding (0-3), stool frequency (0-3), physician's global assessment (0-3) and Mayo endoscopic subscore (0-3). tMS was reported as a 0-12 point score with 12 reflecting the highest severity.
Baseline to Week 8
Phase 3 Maintenance: Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Maintenance Week (mWeek) 44
Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1. The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity. Participants with missing Week 44 values were imputed as non-responders.
mWeek 44
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
Number of Participants Who Demonstrated Clinical Remission by Adapted Mayo Score Components at Week 8
Clinical remission by Adapted Mayo score was defined based on Adapted Mayo score components within specific ranges: stool frequency score of 0 or 1, a rectal bleeding subscore of 0 and a Mayo endoscopy subscore of 0 or 1. The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity.
Week 8
Phase 3 Maintenance: Number of Participants Who Demonstrated a Clinical Response by Adapted Mayo Score Components at mWeek 44
Clinical response was defined as a reduction from baseline in adapted Mayo score of ≥ 2 points and ≥ 30% relative to baseline. It also required ≥ 1 reduction in the rectal bleeding subscore or an absolute subscore ≤ 1. The Adapted Mayo score was the sum of three components: rectal bleeding, stool frequency, and Mayo endoscopic subscore, each measured on a scale of 0-3 with higher scores reflecting higher severity. Participants with missing Week 44 values were imputed as non-responders.
Baseline to mWeek 44
Phase 3 Maintenance: Number of Participants Who Demonstrated Endoscopic Remission by Adapted Mayo Score Components at mWeek 44
Endoscopic remission was defined as an endoscopic subscore ≤ 1. Endoscopic subscore was measured using scale of 0-3, where higher numbers reflected greater severity.
mWeek 44
Phase 3 Maintenance: Number of Participants Who Demonstrated Symptomatic Remission by Adapted Mayo Score Components at mWeek 44
Symptomatic remission was defined as a stool frequency score ≤ 1 and a rectal bleeding subscore of 0. Stool frequency score and rectal bleeding score were each measured using scale of 0-3, where higher numbers reflected greater severity. Participants with missing Week 44 values were imputed as non-responders.
mWeek 44
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
  • Is at least 18 years of age at screening
  • Has a history of UC for at least 3 months prior to screening
  • Has moderately-to-severely active UC, as defined by a Mayo endoscopic subscore of ≥2 points and an adapted Mayo score between 4 - 9 points inclusive
  • Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids, immunomodulators) or biologics
  • Willing to use highly-effective methods of contraception during the study and for 7 days after the last dose
  • Additional inclusion criteria apply

  • Has symptoms suggestive of fulminant colitis, megacolon or intestinal perforation
  • Likely to require surgery for UC or other major surgeries
  • Has previously received / is currently receiving prohibited medications within specified timeframe
  • Is refractory to 3 biologics with ≥2 mechanisms of action
  • Has a current bacterial, parasitic, fungal, or viral infection
  • Has clinically significant abnormalities in laboratory evaluations
  • Has had any prior exposure to an approved Janus kinase (JAK) inhibitor or potential exposure to an investigational JAK inhibitor that was stopped due to intolerance or lack of efficacy
  • Additional exclusion criteria apply
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