A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)

Browse trials for

• Colitis, Ulcerative 1,492
• Inflammatory Bowel Diseases 1,460
• Gastrointestinal Diseases 628
• Colitis 1,073

Keywords

• Inflammatory Bowel Disease
• Gastrointestinal Disease
• Ulcerative Colitis
• Colitis

Colitis, Ulcerative

1,492 studies on the registry are indexed under Colitis, Ulcerative; 399 are open to participants now.

This study's enrollment of 79 is above the median of 71 across 1,042 interventional studies indexed under Colitis, Ulcerative.

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Study arms

• Experimental
  Vixarelimab Dose Regimen 1

  Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.

  Drug: Vixarelimab

• Experimental
  Vixarelimab Dose Regimen 2

  Participants will receive vixarelimab SC during the induction period and the optional ATE period.

  Drug: Vixarelimab

• Placebo comparator
  Placebo

  Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.

  Drug: Vixarelimab · Drug: Placebo

Interventions

• DrugVixarelimab

  Vixarelimab will be administered as per the schedule specified in the respective arms.

  Also known as: RO7622888; KPL-716

• DrugPlacebo

  Vixarelimab matching placebo will be administered as per the schedule specified in the respective arms.

Primary outcomes

1. Percentage of Participants With Clinical Remission 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.

   Time frame: At Week 12

Secondary outcomes

1. Percentage of Participants With Clinical Response 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.

   Time frame: At Week 12

2. Percentage of Participants With Endoscopic Improvement 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.

   Time frame: At Week 12

3. Percentage of Participants With Endoscopic Remission 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.

   Time frame: At Week 12

4. Number of Participants With Adverse Events (AEs)

   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.

   Time frame: 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)

5. Serum Concentration of Vixarelimab at Specified Timepoints

   Time frame: Weeks 0, 1, 2, 4, 8, 12, and study completion/early termination (up to 22 weeks)

6. Induction: Number of Participants With Anti-drug Antibodies (ADAs)

   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.

   Time frame: Baseline and post-baseline visits (up to 12 weeks)

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Oct 29, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing