Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 10 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Upadacitinib |
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Tulisokibart |
| Pfizer Inc. | PFE | 8 | PHASE3 | Etrasimod |
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Filgotinib |
| Abivax SA Sponsored ADR | ABVX | 2 | PHASE3 | ABX464 |
| Bristol-Myers Squibb Company | BMY | 5 | PHASE2 | Ozanimod |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| AnaptysBio, Inc. | ANAB | 1 | PHASE2 | Rosnilimab |
| Palatin Technologies, Inc. | PTN | 1 | PHASE2 | PL8177 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4528287 |
| Xencor, Inc. | XNCR | 1 | PHASE1 | XmAb942 |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE2 | 627 |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Etrozulimab is an investigational small molecule being studied for the treatment of ulcerative colitis, a form of inflammatory bowel disease. It is being developed by Roche Holding AG. The drug is currently in Phase 3 clinical development, meaning it is still being tested and is not yet approved for use.
The specific molecular target of Etrozulimab has not been disclosed in available information. The drug is a small molecule being developed by Roche Holding AG for ulcerative colitis. It is currently in Phase 3 clinical trials, but its mechanism of action has not been publicly detailed.
Etrozulimab is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical trials to evaluate the drug's safety and efficacy in patients with ulcerative colitis. The drug is currently in Phase 3 development, and Roche is the sponsor of the ongoing research.
Etrozulimab is in Phase 3 clinical development. It is an investigational drug being studied for the treatment of ulcerative colitis. The drug is not yet approved by regulatory authorities, and its safety and efficacy are still being evaluated in clinical trials.
Etrozulimab has been studied in one Phase 3 clinical trial with the identifier NCT02100696. This completed trial enrolled 609 participants with ulcerative colitis who had previously been exposed to TNF inhibitors. The study was randomized, double-blind, and placebo-controlled, and it took place across multiple countries including the United States.
Yes, Etrozulimab is the same as etrolizumab. The drug is also known by the name etrolizumab, and both names refer to the same investigational therapy being developed by Roche Holding AG for ulcerative colitis. It is currently in Phase 3 clinical development.