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Also known as UTTR1147A, RG7880, RO7021610, IL-22Fc
Efmarodocokin Alfa · 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...
Efmarodocokin Alfa is an investigational small molecule being studied for the treatment of Acute Graft-versus-host Disease, a condition that can occur after allogeneic hematopoietic stem cell transplantation. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Efmarodocokin Alfa is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug in patients with Acute Graft-versus-host Disease.
Efmarodocokin Alfa is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for its safety and pharmacokinetics in patients with Acute Graft-versus-host Disease.
Efmarodocokin Alfa has one completed clinical trial, NCT04539470, which evaluated the safety and pharmacokinetics of the drug in combination with standard of care in participants undergoing allogeneic hematopoietic stem cell transplantation. The trial enrolled 18 participants in the United States and was a controlled, non-randomized study.
Efmarodocokin Alfa is a distinct investigational drug being developed by Roche Holding AG. No alternative names for this drug have been identified in the available clinical trial information. It is being studied specifically for Acute Graft-versus-host Disease.