רדאר קליני AI | ||
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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. | ||
Efficacy & Safety of TD-1473 in Ulcerative Colitis (RHEA) שלב II, שלב III 239
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
- RHEA
- 0157
- 2018-002136-24 (מספר EudraCT)
שלב III
Janus kinase inhibitor
JAK inhibitor
Inflammatory Bowel Disease
IBD
Ulcerative colitis
UC
Gut selective
| קבוצת משתתפים/זרוע | התערבות/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 |
| מדד תוצאה | תיאור המדידה | טווח 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 |
| מדד תוצאה | תיאור המדידה | טווח 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 |
- 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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