Trial · NCT06137183
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
NCT06137183, Phase 2, Terminated, Genentech, Inc.; results first posted 2026-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC). Trials, record NCT06137183. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06137183
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
- NCT number
- NCT06137183
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 79 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Ulcerative Colitis
- Interventions
- Vixarelimab, Placebo
- First posted
- 2023-11-18
- Last updated
- 2026-02-24
- Results first posted
- 2026-02-24
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinical Remission at Week 12 | At Week 12 | Clinical remission was defined as modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore ≤ 1, rectal bleeding subscore=0, \& endoscopy subscore ≤ 1 (score of 1 modified to exclude friability). MMS is a composite of 3 Mayo Score assessments, each scored on a scale from 0-3. The total score ranges from 0-9, with higher scores indicating more severe disease: stool frequency (0=Normal number of stools, 1=1-2 more stools than normal, 2=3-4 more stools than normal, 3=5 or more stools than normal); rectal bleeding (0=No blood seen or no bowel movement, 1=Stool with streaks of blood, 2=Stool with more than streaks of blood, 3=Blood alone passed); centrally read endoscopy (0=Normal appearance of mucosa, 1=Mild disease \[erythema, decreased vascular pattern\], 2=Moderate disease \[marked erythema, absent vascular pattern, friability, erosions\], 3=Severe disease \[spontaneous bleeding, ulceration\]). Percentages have been rounded off. |
| Secondary | Percentage of Participants With Clinical Response at Week 12 | At Week 12 | Clinical response was defined as decrease from baseline in mMS of ≥ 2 \& ≥ 30% reduction from baseline and also decrease in rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤ 1. MMS is a composite of 3 Mayo Score assessments, each scored on a scale from 0-3. The total score ranges from 0-9, with higher scores indicating more severe disease. Rectal bleeding scores are: 0=No blood seen or no bowel movement, 1=Stool with streaks of blood, 2=Stool with more than streaks of blood, 3=Blood alone passed. Percentages have been rounded off. |
| Secondary | Percentage of Participants With Endoscopic Improvement at Week 12 | At Week 12 | Endoscopic improvement was defined as a Mayo endoscopy subscore of ≤ 1 (score of 1 modified to exclude friability). Endoscopy scores were based on interpretation by a blinded central reader. The Mayo Score consists of participant-reported outcomes (stool frequency, rectal bleeding), endoscopy, and clinician-reported outcome (Physician's Global Assessment) components. The Mayo endoscopy sub-score ranges from 0 to 3 (0= No inflammation; 1= Mild inflammation \[erythema, decreased vascular pattern\]; 2=Moderate inflammation \[marked erythema, absent vascular pattern, and friability\]; 3= Severe inflammation \[ulceration and spontaneous bleeding\]), with higher scores indicating more severe disease. Percentages have been rounded off. |
| Secondary | Percentage of Participants With Endoscopic Remission at Week 12 | At Week 12 | Endoscopic remission was defined as a Mayo endoscopy subscore of 0. Endoscopy scores were based on interpretation by a blinded central reader. The Mayo Score consists of participant-reported outcomes (stool frequency, rectal bleeding), endoscopy, and clinician-reported outcome (Physician's Global Assessment) components. The Mayo endoscopy sub-score ranges from 0 to 3 (0= No inflammation; 1= Mild inflammation \[erythema, decreased vascular pattern and mild friability\]; 2=Moderate inflammation \[marked erythema, absent vascular pattern, and friability\]; 3= Severe inflammation \[ulceration and spontaneous bleeding\]), with higher scores indicating more severe disease. Percentages have been rounded off. |
| Secondary | Number of Participants With Adverse Events (AEs) | Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks) | An AE was defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any of the following: Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; Any new disease or exacerbation of existing disease; Recurrence of an intermittent medical condition not present at baseline; Any deterioration in a laboratory value or other clinical test, associated with symptoms or leads to change in study treatment or concomitant treatment or discontinuation from study treatment; AEs related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment. |
| Secondary | Serum Concentration of Vixarelimab at Specified Timepoints | Weeks 0, 1, 2, 4, 8, 12, and study completion/early termination (up to 22 weeks) | |
| Secondary | Induction: Number of Participants With Anti-drug Antibodies (ADAs) | Baseline and post-baseline visits (up to 12 weeks) | Participants were considered to be ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (treatment-enhanced ADA response). The total number of participants who developed ADAs to vixarelimab was determined by summing the ADA-positive participants across all timepoints. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinical Remission at Week 12 | At Week 12 | mITT included all participants who received at least one dose of study treatment and had at least one post-baseline efficacy measurement, with participants grouped according to their assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response at Week 12 | At Week 12 | mITT included all participants who received at least one dose of study treatment and had at least one post-baseline efficacy measurement, with participants grouped according to their assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Endoscopic Improvement at Week 12 | At Week 12 | mITT included all participants who received at least one dose of study treatment and had at least one post-baseline efficacy measurement, with participants grouped according to their assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Endoscopic Remission at Week 12 | At Week 12 | mITT included all participants who received at least one dose of study treatment and had at least one post-baseline efficacy measurement, with participants grouped according to their assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks) | Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum Concentration of Vixarelimab at Specified Timepoints | Weeks 0, 1, 2, 4, 8, 12, and study completion/early termination (up to 22 weeks) | Pharmacokinetic (PK)-evaluable population included all participants with at least one post-dose serum PK sample in which vixarelimab concentration was evaluable. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | micrograms per milliliter (µg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Induction: Number of Participants With Anti-drug Antibodies (ADAs) | Baseline and post-baseline visits (up to 12 weeks) | Safety-evaluable population included all randomized participants who received at least one dose of study treatment, with participants grouped according to treatment received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Clinical Remission at Week 12 | Arm A: Vixarelimab 720 mg Q2W | 11.1 | 95% Confidence Interval 3.85 to 28.06 | percentage of participants | |
| Percentage of Participants With Clinical Remission at Week 12 | Arm B: Vixarelimab 720 mg Q4W | 3.8 | 95% Confidence Interval 0.68 to 18.89 | percentage of participants | |
| Percentage of Participants With Clinical Remission at Week 12 | Arm C: Placebo | 11.5 | 95% Confidence Interval 4.00 to 28.98 | percentage of participants | |
| Percentage of Participants With Clinical Response at Week 12 | Arm A: Vixarelimab 720 mg Q2W | 29.6 | 95% Confidence Interval 15.85 to 48.48 | percentage of participants | |
| Percentage of Participants With Clinical Response at Week 12 | Arm B: Vixarelimab 720 mg Q4W | 19.2 | 95% Confidence Interval 8.51 to 37.88 | percentage of participants | |
| Percentage of Participants With Clinical Response at Week 12 | Arm C: Placebo | 26.9 | 95% Confidence Interval 13.70 to 46.08 | percentage of participants | |
| Percentage of Participants With Endoscopic Improvement at Week 12 | Arm A: Vixarelimab 720 mg Q2W | 11.1 | 95% Confidence Interval 3.85 to 28.06 | percentage of participants | |
| Percentage of Participants With Endoscopic Improvement at Week 12 | Arm B: Vixarelimab 720 mg Q4W | 3.8 | 95% Confidence Interval 0.68 to 18.89 | percentage of participants | |
| Percentage of Participants With Endoscopic Improvement at Week 12 | Arm C: Placebo | 19.2 | 95% Confidence Interval 8.51 to 37.88 | percentage of participants | |
| Percentage of Participants With Endoscopic Remission at Week 12 | Arm A: Vixarelimab 720 mg Q2W | 0 | 95% Confidence Interval 0.00 to 12.46 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period | STARTED | Arm A: Vixarelimab 720 mg Q2W | 27 | |
| Induction Period | STARTED | Arm B: Vixarelimab 720 mg Q4W | 26 | |
| Induction Period | STARTED | Arm C: Placebo | 26 | |
| Induction Period | STARTED | Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W | 0 | |
| Induction Period | STARTED | Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W | 0 | |
| Induction Period | STARTED | Arm C: Placebo to Vixarelimab 720 mg Q2W | 0 | |
| Induction Period | COMPLETED | Arm A: Vixarelimab 720 mg Q2W | 15 | |
| Induction Period | COMPLETED | Arm B: Vixarelimab 720 mg Q4W | 10 | |
| Induction Period | COMPLETED | Arm C: Placebo | 17 | |
| Induction Period | COMPLETED | Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events222
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Arm A: Vixarelimab 720 mg Q2W | 0 | 27 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Vixarelimab 720 mg Q4W | 0 | 26 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Arm C: Placebo | 0 | 26 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W | 1 | 15 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W | 0 | 10 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Arm C: Placebo to Vixarelimab 720 mg Q2W | 1 | 17 | 1 |
| other | Atrioventricular block first degree | Cardiac disorders | Arm A: Vixarelimab 720 mg Q2W | 0 | 27 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Arm B: Vixarelimab 720 mg Q4W | 0 | 26 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Arm C: Placebo | 0 | 26 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W | 0 | 15 | 0 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Vixarelimab 720 mg Q2W | 0 | 27 |
| Total, all-cause mortality | Arm B: Vixarelimab 720 mg Q4W | 0 | 26 |
| Total, all-cause mortality | Arm C: Placebo | 0 | 26 |
| Total, all-cause mortality | Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W | 0 | 15 |
| Total, all-cause mortality | Arm B: Vixarelimab 720 mg Q4W to Vixarelimab 720 mg Q4W | 0 | 10 |
| Total, all-cause mortality | Arm C: Placebo to Vixarelimab 720 mg Q2W | 0 | 17 |
| Total, other adverse events | Arm A: Vixarelimab 720 mg Q2W | 8 | 27 |
| Total, other adverse events | Arm B: Vixarelimab 720 mg Q4W | 9 | 26 |
| Total, other adverse events | Arm C: Placebo | 3 | 26 |
| Total, other adverse events | Arm A: Vixarelimab 720 mg Q2W to Vixarelimab 720 mg Q2W | 9 | 15 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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