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Also known as Efmarodocokin alfa, RO7021610, RG7880, IL-22Fc
UTTR1147A · 4 trials · 4 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: Efmarodocokin Alfa Dosage Level 1 | EXPERIMENTAL | Participants undergoing allogeneic hematopoietic stem cell transplantation will receive Efmarodocokin Alfa dosage level 1 in combination with standard of care prophylaxis treatment for acute graft versus-host disease (aGVHD), consisting of tacrolimus plus methotrexate per institutional practices. |
| Cohort B: Efmarodocokin Alfa Dosage Level 2 | EXPERIMENTAL | Participants undergoing allogeneic hematopoietic stem cell transplantation will receive Efmarodocokin Alfa dosage level 2 in combination with standard of care prophylaxis treatment for acute graft versus-host disease (aGVHD), consisting of tacrolimus plus methotrexate per institutional practices. |
| Cohort C: Efmarodocokin Alfa Dosage Level 3 | EXPERIMENTAL | Participants undergoing allogeneic hematopoietic stem cell transplantation will receive Efmarodocokin Alfa dosage level 3 in combination with standard of care prophylaxis treatment for acute graft versus-host disease (aGVHD), consisting of tacrolimus plus methotrexate per institutional practices. |
| 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. |
| Efmarodocokin Alfa | DRUG | Efmarodocokin Alfa will be administered intravenously (IV) per the dosage specified in each dose escalation cohort. |
| 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...
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UTTR1147A is an investigational small molecule being studied for ulcerative colitis and neuropathic diabetic foot ulcers. It has been evaluated in clinical trials for these conditions, including a Phase 2 study in moderate to severe ulcerative colitis. UTTR1147A is not approved and remains in clinical development.
UTTR1147A is being developed by Roche Holding AG, traded on the OTC market under the ticker RHHBY. Roche has sponsored clinical trials of UTTR1147A in ulcerative colitis 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 moderate to severe ulcerative colitis, which has been completed. UTTR1147A is investigational and not FDA approved.
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 ulcerative colitis.
No, UTTR1147A is not the same as vedolizumab. In a Phase 2 trial, UTTR1147A was compared with placebo and with vedolizumab in participants with moderate to severe ulcerative colitis. UTTR1147A is a separate investigational small molecule developed by Roche.