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Immunomodulator

Povetacicept for Autoimmune Hemolytic Anemia (RUBY-4 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Alpine Immune Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Warm Autoimmune Hemolytic Anemia (wAIHA): Diagnosis of primary wAIHA of at least 12 weeks duration documented with a current or prior positive direct antiglobulin test (DAT) for anti-IgG (±C3d), Documented history of anemia with hemoglobin ≤9 g/dL, At least one of the following: (i) haptoglobin <LLN (ii) indirect bilirubin >ULN (iii) lactate dehydrogenase>ULN, History of failure or relapse to at least 2 treatment regimens for wAIHA
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 1 through 30 days after last dose of study drug
Awards & highlights

RUBY-4 Trial Summary

This trial will assess a drug (povetacicept) to treat autoimmune cytopenias (e.g. thrombocytopenia, anemia, cold agglutinin) in adults to determine if it's safe & effective. Participants will receive the drug every 4 weeks for 6 months.

Who is the study for?
Adults with autoimmune cytopenias like immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease can join. They must have tried at least one or two treatments before without success. Participants should not have had certain recent treatments (like plasmapheresis), a splenectomy, or blood transfusions shortly before the trial starts.Check my eligibility
What is being tested?
The study is testing povetacicept to see if it's safe and effective for treating autoimmune cytopenias. Participants will receive doses every four weeks for six months, with a chance to continue in a six-month extension period of the treatment.See study design
What are the potential side effects?
Possible side effects are not detailed here but typically could include reactions at the injection site, increased risk of infections due to immune system suppression, fatigue, headaches, and potential impacts on liver function.

RUBY-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with wAIHA for over 12 weeks, have low hemoglobin, and treatments haven't worked.

RUBY-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 1 through 30 days after last dose of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 1 through 30 days after last dose of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events

RUBY-4 Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2: povetacicept Dose BExperimental Treatment1 Intervention
Group II: Part 2: povetacicept Dose AExperimental Treatment1 Intervention
Group III: Part 1: povetacicept 240mgExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Alpine Immune Sciences, Inc.Lead Sponsor
8 Previous Clinical Trials
460 Total Patients Enrolled
Ismail SimsekStudy DirectorAlpine Immune Sciences, Inc.
Allison NaumovskiStudy DirectorAlpine Immune Sciences, Inc.

Media Library

Povetacicept (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05757570 — Phase 1 & 2
Cold Agglutinin Disease Research Study Groups: Part 1: povetacicept 240mg, Part 2: povetacicept Dose A, Part 2: povetacicept Dose B
Cold Agglutinin Disease Clinical Trial 2023: Povetacicept Highlights & Side Effects. Trial Name: NCT05757570 — Phase 1 & 2
Povetacicept (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05757570 — Phase 1 & 2

Frequently Asked Questions

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

Is enrollment currently available for this medical trial?

"This trial, which was initially posted on July 3rd 2023 and recently revised on the 7th of the same month, is presently searching for suitable candidates. Information about this clinical study can be found on clinicaltrials.gov."

Answered by AI

Is the administration of povetacicept 240mg medically sound?

"Owing to the limited data available on both safety and efficacy, povetacicept 240mg was assigned a score of 1."

Answered by AI

What is the geographical scope of this investigation?

"At present, this experiment is being conducted in 5 different locations--Washington, Iowa City and Greenville among them. Prospective participants should try to select the closest facility possible so as to abate travel costs."

Answered by AI

What is the sample size of participants in this experiment?

"This trial requires 42 participants, who meet the admittance requirements. Candidates can be recruited from various locations including Investigational Site (401) in Washington D.C., and Investigational Site (219) located in Iowa City, Iowa."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias
2023. "An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05757570.
All > Thrombocytopenia
~84 spots leftby Nov 2027
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