Trial · NCT03395184
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES CD50) at Week 12: Induction Period | Week 12 | FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Laboratory Test Abnormalities During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | Safety analysis set (SAS) included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to Categorization of Vital Signs During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Discontinuations Due to Adverse Events During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities During Induction Period | From start of study intervention on Day 1 up to Week 12 | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants According to Categorization of Vital Signs During Induction Period | From start of study intervention on Day 1 up to Week 12 | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here, 'Number Analyzed' signifies number of participants evaluable for specific rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During Induction Period | From start of study intervention on Day 1 up to Week 12 | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During Induction Period | From start of study intervention on Day 1 up to Week 12 | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During Induction Period | From start of study intervention on Day 1 up to Week 12 | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Discontinuation Due to Adverse Events During Induction Period | From start of study intervention on Day 1 up to Week 12 | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Infections During Induction Period | From start of study intervention on Day 1 up to Week 12 | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Achieved Clinically Meaningful Endoscopic Improvement (CMEI) (Reduction of >=3 Points From Baseline in SES-CD Score) at Week 12: Induction Period | Week 12 | FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in SES-CD Score at Week 12: Induction Period | Baseline and Week 12 | FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving >=25% Reduction in SES-CD From Baseline (SES-CD 25) at Week 12: Induction Period | Week 12 | FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Endoscopic Remission (SES-CD Score of <= 2) at Week 12: Induction Period | Week 12 | FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Mucosal Healing at Week 12: Induction Period | Week 12 | FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving CMEI at Week 64 Among Participants Who Achieved CMEI Response at Week 12 (Baseline of OLE Period): OLE Period | Week 64 (Week 52 of OLE period) | FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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