RLS-0071 for Graft-versus-Host Disease

(AURORA Trial)

Recruiting at 18 trial locations

Overseen By Linda Dell, MBA

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: ReAlta Life Sciences, Inc.

Must be taking: Corticosteroids, Ruxolitinib

Must not be taking: Systemic treatments

Disqualifiers: Chronic GvHD, Severe organ dysfunction, Active sepsis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called RLS-0071 for individuals with acute Graft-versus-Host Disease (aGvHD), a serious condition that can occur after a bone marrow transplant. The trial aims to assess the safety and effectiveness of RLS-0071 for those who do not respond to steroids. Participants will receive varying doses of RLS-0071, sometimes in combination with another drug, ruxolitinib, to determine the optimal dosing strategy. The trial seeks hospitalized patients with steroid-resistant aGvHD post-transplant, who are expected to remain in the hospital for at least a week. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications, but it does require that you do not add, adjust, or stop any GvHD prophylactic medications during the 7-day treatment with RLS-0071.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that RLS-0071, also known as pegtarazimod, appears safe for treating acute Graft-versus-Host Disease (aGvHD). Although detailed safety data from human trials is not yet available, earlier animal studies showed good results. These studies suggest that the treatment is generally well-tolerated, with no serious side effects observed.

Additionally, the European Medicines Agency has granted RLS-0071 orphan drug status. This designation is often given to treatments that could benefit rare conditions, suggesting its potential safety. The current trial's advanced stage indicates that earlier studies did not find major safety issues. However, individual reactions to medical treatments can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

RLS-0071 is unique for treating graft-versus-host disease because it targets the underlying inflammation differently. While most current treatments, like steroids and immunosuppressants such as ruxolitinib, broadly suppress the immune system, RLS-0071 specifically aims to modulate the inflammatory pathways more precisely, potentially reducing side effects. Researchers are excited about RLS-0071 because it may offer a more targeted approach, which could lead to better outcomes and improved quality of life for patients with fewer complications.

What evidence suggests that this trial's treatments could be effective for acute Graft-versus-Host Disease?

Research has shown that RLS-0071, also known as pegtarazimod, may help treat acute Graft-versus-Host Disease (aGvHD), especially when steroids are no longer effective. In animal studies, RLS-0071 significantly improved survival rates. This treatment reduces inflammation, a major issue in aGvHD. In this trial, some participants will receive RLS-0071 alone, while others will receive it in combination with ruxolitinib to evaluate if the combination is even more effective. The European Medicines Agency has recognized its potential by granting it orphan drug status, highlighting its importance for this condition. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for hospitalized adults and adolescents over 12 years old, weighing between 40-140 kg, with grade II-IV acute Graft-versus-Host Disease that hasn't improved with steroids. Participants must have recovered neutrophils after a stem-cell transplant and expect to stay in the hospital for at least one week.

Inclusion Criteria

I am older than 12 years.

I am in the hospital for aGvHD that didn't respond to steroids after a stem cell transplant.

I won't change my GvHD treatment plan for 7 days during RLS-0071 treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RLS-0071 in various dosing regimens for 7 to 14 days, with some cohorts receiving concurrent ruxolitinib

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RLS-0071

Trial Overview The study tests RLS-0071's safety and effectiveness as a secondary treatment for steroid-refractory acute Graft-versus-Host Disease. It involves varying doses of RLS-0071 to find the right balance between efficacy and tolerability.

How Is the Trial Designed?

Group I: RLS-0071Cohort 1 Experimental Treatment 1 Intervention

10 mg/kg Q8H RLS-0071 for 7 days

Group II: RLS-0071 Expansion Cohort 2 Experimental Treatment 1 Intervention

12 participants will receive 20 mg/kg Q8H RLS-0071 for 14 days

Group III: RLS-0071 Expansion Cohort 1 Experimental Treatment 1 Intervention

12 participants will receive 10 mg/kg Q8H RLS-0071 for 14 days

Group IV: RLS-0071 Cohort 5 Experimental Treatment 1 Intervention

20 mg/kg Q8H RLS-0071 for 7 days and then 20 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib

Group V: RLS-0071 Cohort 4 Experimental Treatment 1 Intervention

10 mg/kg Q8H RLS-0071 for 7 days and then 10 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib

Group VI: RLS-0071 Cohort 3 Experimental Treatment 1 Intervention

20 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib

Group VII: RLS-0071 Cohort 2 Experimental Treatment 1 Intervention

10 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib

Who Is Running the Clinical Trial?

ReAlta Life Sciences, Inc.

Lead Sponsor

Trials

6

Recruited

220+

CTI Clinical Trial and Consulting Services

Collaborator

Trials

36

Recruited

3,700+

Citations

1. realtalifesciences.com realtalifesciences.com/news/realta-announces-positive-preclinical-data-for-rls-0071-pegtarazimod-in-acute-graft-versus-host-disease-at-american-society-of-hematology-annual-meeting/

Data demonstrates pegtarazimod's ... ReAlta Life Sciences Announces Positive Preclinical Data for RLS-0071 (pegtarazimod) in Acute Graft-Versus-Host Disease (aGVHD) at American ...

2. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/3399/533360/Exploring-a-Novel-Anti-Inflammatory-Peptide-As-a

Exploring a Novel Anti-Inflammatory Peptide As a Potential ... Results: RLS-0071 significantly improves the survival of mice in multiple in vivo models of aGVHD, both when treatment is used to prevent the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06343792

Study Details | NCT06343792 | Safety, PK, PD, Dosing, ... Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease (AURORA).

4. ctsearchsupport.org ctsearchsupport.org/clinical-trials/safety-pk-pd-dosing-and-efficacy-of-rls-0071for-the-treatment-of-hospitalized-patients-with-steroid-refractory-acute-graft-versus-host-disease

A drug, RLS-0071 , alone or with ruxolitinib, to treat acute ... If the combination of RLS-0071, alone or with ruxolitinib , is safe and works well to treat acute GVHD that is refractory to steroids.

5. onclive.com onclive.com/view/ema-grants-orphan-drug-designation-to-pegtarazimod-for-gvhd

EMA Grants Orphan Drug Designation to Pegtarazimod for ... Pegtarazimod has received orphan drug designation from the European Medicines Agency for the management of graft-vs-host disease.

6. gvhdhub.com gvhdhub.com/medical-information/rls-0071-pegtarazimod-granted-orphan-drug-designation-by-the-ema

RLS-0071 (pegtarazimod) granted orphan drug ... On August 21, 2025, RLS-0071 (pegtarazimod) received EMA orphan drug designation for the treatment of GvHD based on phase II study data in ...

7. clinicaltrialsarena.com clinicaltrialsarena.com/news/realta-patient-agvhd-trial/

ReAlta Life Sciences begins trial of graft-versus-host ... The primary goals of the study are to evaluate the safety and overall response rate in patients who are given RLS-0071. September 24, 2024.