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UTTR1147A · 3 trials · 3 indications
Clinical remission is defined as modified Mayo Clinic Score (mMCS) \<= 2 with Mayo rectal bleeding subscore = 0, Mayo stool frequency subscore \<=1 and Centrally read endoscopic score \<= 1. Patients were classified as Non-Remitters if Week 8 assessments were missing or patient received permitted/ prohibited Rescue Therapy prior to assessment.
| Arm | Type | Description |
|---|---|---|
| Arm 1a: UTTR1147A Dose Level 1 (Part A) + UTTR1147A (Part B) | EXPERIMENTAL | Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo. |
| Arm 1b: UTTR1147A Dose Level 1 (Part A) + Placebo (Part B) | EXPERIMENTAL | Part A: UTTR1147A dose level 1 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo. |
| Arm 2a: UTTR1147A Dose Level 2 (Part A) + UTTR1147A (Part B) | EXPERIMENTAL | Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo. |
| Arm 2b: UTTR1147A Dose Level 2 (Part A) + Placebo (Part B) | EXPERIMENTAL | Part A: UTTR1147A dose level 2 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo. |
| Arm 3a: UTTR1147A Dose Level 3 (Part A) + UTTR1147A (Part B) | EXPERIMENTAL | Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A maintenance dose and Vedolizumab Placebo. |
| Arm 3b: UTTR1147A Dose Level 3 (Part A) + Placebo (Part B) | EXPERIMENTAL | Part A: UTTR1147A dose level 3 and Vedolizumab Placebo. Part B: UTTR1147A Placebo and Vedolizumab Placebo. |
| Arm 4: Vedolizumab | ACTIVE_COMPARATOR | Parts A and B: Vedolizumab and UTTR1147A Placebo. |
| Arm 5: Placebo | PLACEBO_COMPARATOR | Parts A and B: UTTR1147A Placebo and Vedolizumab Placebo. |
| Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1 | EXPERIMENTAL | Participants with 0.8-6.0 centimeters square (cm\^2) index ulcer area at screening and no infection in index ulcer will receive UTTR1147A SC at Dose Level 1 for 12 weeks (a total of 4 doses). |
| Cohort B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2 | EXPERIMENTAL | Participants with 0.8-6.0 cm\^2 index ulcer area at screening and no infection in index ulcer will receive UTTR1147A SC at Dose Level 2 for 12 weeks (a total of 4 doses). |
| Cohort C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2 | EXPERIMENTAL | Participants with 0.8-6.0 cm\^2 index ulcer area at screening and mild infection in index ulcer will receive UTTR1147A SC at Dose Level 2 for 12 weeks (a total of 4 doses). |
| Cohort D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2 | EXPERIMENTAL | Participants with 1.5-6.0 cm\^2 index ulcer area at screening and mild infection in index ulcer will receive UTTR1147A SC at Dose Level 2 for 12 weeks (a total of 4 doses). |
| Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3 | EXPERIMENTAL | Participants with 0.8-6.0 cm\^2 index ulcer area at screening and mild infection in index ulcer will receive UTTR1147A SC at Dose Level 3 for 12 weeks (a total of 4 doses). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses). |
| Healthy Volunteer | EXPERIMENTAL | Participants will be given escalating doses of UTTR1147A or Placebo intravenously |
| Ulcerative Colitis | EXPERIMENTAL | Participants will be given escalating doses of UTTR1147A or Placebo intravenously |
| Crohn's Disease | EXPERIMENTAL | Participants will be given escalating doses of UTTR1147A or Placebo intravenously |
| Name | Type | Description |
|---|---|---|
| UTTR1147A | DRUG | UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions. |
| UTTR1147A Placebo | DRUG | The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV. |
| Vedolizumab | DRUG | Vedolizumab will be administered IV, as specified in the prescribing information. |
| Vedolizumab Placebo | DRUG | The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV. |
| Placebo | DRUG | UTTR1147A matching placebo will be administered SC. |
Inclusion Criteria: * Diagnosis of UC * Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score * Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor \[TNF...
| 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 |
UTTR1147A is an investigational small molecule being studied for neuropathic diabetic foot ulcers and ulcerative colitis. It has been evaluated in Phase 1 and Phase 2 clinical trials, including a study in participants with moderate to severe ulcerative colitis. The drug is not approved and remains in clinical development.
UTTR1147A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company has sponsored clinical trials of the drug in healthy volunteers and in patients with ulcerative colitis, Crohn's disease, and neuropathic diabetic foot ulcers.
UTTR1147A has completed Phase 1 and Phase 2 clinical trials. The most advanced study was a Phase 2 trial in ulcerative colitis, which has been completed. The drug is investigational and has not been approved by regulatory authorities.
UTTR1147A has been studied in three completed trials: NCT02749630, a Phase 1 safety study in healthy volunteers and participants with ulcerative colitis or Crohn's disease; NCT02833389, a Phase 1 study in neuropathic diabetic foot ulcers; and NCT03558152, a Phase 2 efficacy study in moderate to severe ulcerative colitis.
No, UTTR1147A is not the same as vedolizumab. In a Phase 2 trial for ulcerative colitis, UTTR1147A was compared directly with placebo and with vedolizumab, indicating they are distinct treatments. UTTR1147A is a small molecule, while vedolizumab is a different type of therapy.