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Also known as PRO145223, RO5490261, RG7413
Etrozulimab · 1 trial · 1 indication
The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0.
The MCS ranges from 0 to 12 and is a composite of 4 assessments (each rated from 0-3): stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores represent greater disease severity. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Etrolizumab (Open-Label Induction (OLI) Phase) | EXPERIMENTAL | Participants assigned to this arm will receive treatment with open-label etrolizumab 105 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) for 14 weeks during the induction phase. |
| Cohort 2: Placebo (Double-Blind Induction Phase) | PLACEBO_COMPARATOR | Participants randomized to this arm will receive treatment with double-blind placebo SC injection Q4W for 14 weeks during the induction phase. |
| Cohort 2: Etrolizumab (Double-Blind Induction Phase) | EXPERIMENTAL | Participants randomized to this arm will receive treatment with double-blind etrolizumab 105 mg SC injection Q4W for 14 weeks during the induction phase. |
| Placebo Responders: Placebo (Maintenance Phase) | PLACEBO_COMPARATOR | Participants who received placebo during the induction phase, Cohort 2: Placebo (Double-Blind Induction Phase), and achieve a clinical response with placebo at Week 14 will continue to receive blinded placebo from Week 16 up to Week 66 during the maintenance phase. |
| Etrolizumab Responders: Placebo (Maintenance Phase) | PLACEBO_COMPARATOR | Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive placebo SC injection Q4W from Week 16 up to Week 66. |
| Etrolizumab Responders: Etrolizumab (Maintenance Phase) | EXPERIMENTAL | Participants who received etrolizumab during the induction phase, Cohort 1: Etrolizumab (Open-Label Induction Phase) and Cohort 2: Etrolizumab (Double-Blind Induction Phase), and achieved a clinical response at Week 14 will be re-randomized by Week 16 for the double-blind maintenance phase. Clinical responders re-randomized to this arm will receive etrolizumab 105 mg SC injection Q4W from Week 16 up to Week 66. |
| Name | Type | Description |
|---|---|---|
| Etrozulimab | DRUG | Participants will receive 105 mg etrolizumab administered by SC injection Q4W. |
| Placebo | DRUG | Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W. |
Inclusion Criteria: * Diagnosis of UC established at least 3 months prior to Day 1 * Moderately to severely active UC as determined by the Mayo Clinic Score (MCS) assessment * Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF i...
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Etrozulimab is an investigational monoclonal antibody developed by Roche Holding AG for the treatment of ulcerative colitis, a form of inflammatory bowel disease. It is being studied in patients with moderate to severe disease, including those who have previously been exposed to TNF inhibitor therapies.
Etrozulimab is being developed for ulcerative colitis, a chronic inflammatory condition of the colon. The Phase 3 study enrolled adults with ulcerative colitis who had been previously exposed to tumor necrosis factor (TNF) inhibitors, a group that often has limited treatment options.
Etrozulimab is developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating the antibody in ulcerative colitis.
Etrozulimab is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 trial in ulcerative colitis has been completed, and the program has not yet advanced to a regulatory approval decision.
Etrozulimab has been evaluated in the Phase 3 trial NCT02100696, titled a study of the efficacy and safety of etrolizumab in participants with ulcerative colitis previously exposed to TNF inhibitors. The trial enrolled 609 participants, was randomized, double-blind, and placebo-controlled, and has been completed.