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Cytokine

Efmarodocokin Alfa for Graft-versus-Host Disease

Phase 1

Waitlist Available

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to 365 days

Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective in preventing aGVHD in people undergoing allogeneic HSCT.

Eligible Conditions

Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 365 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline up to 365 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Body Temperature Over Time

Change from Baseline in Diastolic Blood Pressure Over Time

Change from Baseline in Oxygen Saturation Over Time

+6 more

Secondary outcome measures

Number of Participants with Anti-Drug Antibodies (ADAs) at Baseline and During the Study

Serum Concentration of Efmarodocokin Alfa at Specified Timepoints

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort C: Efmarodocokin Alfa Dosage Level 3Experimental Treatment1 Intervention

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.

Group II: Cohort B: Efmarodocokin Alfa Dosage Level 2Experimental Treatment1 Intervention

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.

Group III: Cohort A: Efmarodocokin Alfa Dosage Level 1Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Efmarodocokin Alfa

2020

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,538 Previous Clinical Trials

567,710 Total Patients Enrolled

Clinical TrialsStudy DirectorGenentech, Inc.

2,198 Previous Clinical Trials

888,430 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent does Efmarodocokin Alfa present a hazard to human health?

"With limited evidence to support its safety and efficacy, our research team has assigned Efmarodocokin Alfa a score of 1 out of 3 on the risk spectrum."

Answered by AI

In how many locations is the research trial being conducted?

"The present clinical trial is happening in 8 distinct locales throughout the US, among them Los Angeles, Chicago and Kansas City. To avoid extensive travel needs if you decide to sign up for this study, it is recommended that you select a location nearest your residence."

Answered by AI

Is this investigation unprecedented in the field?

"Currently, a single trial for Efmarodocokin Alfa is active across 8 locations and 1 nation. The initial experiment was sponsored by Genentech, Inc., initiated in 2020 with 18 human participants and finished Phase I drug approval process. Subsequent to the original study's completion 5 further trials have been conducted."

Answered by AI

How many participants are being recruited for this experiment?

"This trial is no longer accepting individuals. Originally posted on November 19th 2020 and last updated September 12th 2022, the study has formally ended recruitment. For those searching for other studies, there are 169 active clinical trials recruiting patients with diseases and one open trial for Efmarodocokin Alfa seeking participants."

Answered by AI

Are there still openings for participants in this trial?

"Unfortunately, this clinical trial is no longer seeking participants. The study was first posted on November 19th 2020, and the most recent update occurred September 12th 2022. For those looking to participate in other trials, there are currently 169 studies with open enrollment for diseases, as well as one research project recruiting patients for Efmarodocokin Alfa."

Answered by AI

Could you provide any insight into previous research conducted on Efmarodocokin Alfa?

"Efmarodocokin Alfa was initially studied in 2020 by researchers at Washington University's School of Medicine. Currently, there are 5 completed clinical trials and a single active trial centered mostly around Los Angeles, California."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

2020. "Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04539470.