Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects With Autoimmune Cytopenias (RUBY-4)

Status: Active_not_recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month study treatment extension period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Indication-specific Criteria

‣ Immune Thrombocytopenia (ITP)

• Documented persistent or chronic primary ITP of at least 12 weeks duration from diagnosis to Cycle 1 Day 1

∙ History of failure or relapse to at least 2 treatment regimens for ITP

∙ History of exposure to a TPO-RA unless otherwise contraindicated or unavailable

∙ Documented history of platelets \<30 × 10\^9/L

⁃ 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 ≤10 g/dL

∙ At least one of the following: (i) haptoglobin \< lower limit of normal (LLN) (ii) indirect bilirubin \> upper limit of normal (ULN) (iii) lactate dehydrogenase\>ULN

∙ History of failure or relapse to at least 2 treatment regimens for wAIHA

⁃ Cold Agglutinin Disease (CAD)

• Diagnosis of primary CAD of at least 12 weeks duration with all of the following: (i) chronic hemolysis (ii) polyspecific DAT positive (iii) monospecific DAT strongly positive for C3d (iv) cold agglutinin titer ≥64 at 4°C (v) IgG DAT ≤1+ (vi) no overt malignant disease

∙ Documented history of anemia with hemoglobin ≤10 g/dL

∙ Evidence of hemolysis during screening: (i) indirect bilirubin \>ULN and (ii) lactate dehydrogenase\>ULN or haptoglobin \<LLN

∙ History of failure or relapse to at least 1 treatment regimen for CAD

• (All indications) If receiving protocol-specified standard-of-care medications, doses must be stable for protocol-specified durations

Locations
United States
California
Investigational Site (230)
Los Angeles
Washington, D.c.
Investigational Site (401)
Washington D.c.
Florida
Investigational Site (419)
Cooper City
Investigational Site (425)
Miami
Iowa
Investigational Site (219)
Iowa City
Maryland
Investigational Site (435)
Columbia
North Carolina
Investigational Site (414)
Charlotte
Investigational Site (402)
Greenville
New York
Investigational site (405)
Lake Success
Investigational Site (423)
New Hyde Park
Investigational Site (404)
New York
Investigational Site (421)
New York
Investigational Site (420)
Shirley
Investigational Site (422)
The Bronx
Washington
Investigational Site (411)
Seattle
Other Locations
Australia
Investigational Site (410)
Box Hill
Investigational Site (519)
Concord
Investigational Site (517)
Douglas
Investigational Site (413)
Liverpool
Investigational Site (407)
West Perth
Investigational Site (409)
Westmead
Austria
Investigational Site (434)
Vienna
Canada
Investigational Site (406)
Greenfield Park
Investigational Site (403)
Hamilton
Investigational Site (444)
Toronto
Germany
Investigational Site (438)
Essen
Italy
Investigational Site (432)
Meldola
Investigational Site (428)
Milan
Investigational Site (431)
Novara
Investigational Site (443)
Trieste
Norway
Investigational Site (433)
Grålum
Investigational Site (437)
Trondheim
Spain
Investigational Site (436)
Barcelona
Investigational Site (429)
Burgos
Investigational Site (430)
Madrid
Investigational Site (426)
Murcia
Investigational Site (427)
Seville
Turkey
Investigational Site (415)
Ankara
Investigational Site (416)
Ankara
Investigational Site (418)
Istanbul
United Kingdom
Investigational Site (442)
Leeds
Investigational Site (439)
London
Investigational Site (440)
London
Investigational Site (441)
London
Time Frame
Start Date: 2023-07-03
Completion Date: 2026-07
Participants
Target number of participants: 30
Treatments
Experimental: Part 1: Povetacicept 240mg
Participants grouped in 3 cohorts by diagnosis will be administered Povetacicept
Experimental: Part 2: Povetacicept Dose A
Based on the findings of Part 1, one or two dose levels may be assessed in Part 2; if two dose levels are assessed participants will be randomized to receive one of the two dose levels of Povetacicept
Sponsors
Leads: Alpine Immune Sciences, Inc.

This content was sourced from clinicaltrials.gov