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

Status: 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)
RECRUITING
Los Angeles
Washington, D.c.
Investigational Site (401)
RECRUITING
Washington
Florida
Investigational Site (419)
RECRUITING
Cooper City
Investigational Site (425)
RECRUITING
Miami
Iowa
Investigational Site (219)
RECRUITING
Iowa City
Maryland
Investigational Site (435)
RECRUITING
Columbia
North Carolina
Investigational Site (414)
RECRUITING
Charlotte
Investigational Site (402)
RECRUITING
Greenville
New York
Investigational Site (422)
RECRUITING
Bronx
Investigational site (405)
RECRUITING
Lake Success
Investigational Site (423)
RECRUITING
New Hyde Park
Investigational Site (404)
RECRUITING
New York
Investigational Site (421)
RECRUITING
New York
Investigational Site (420)
RECRUITING
Shirley
Washington
Investigational Site (411)
RECRUITING
Seattle
Other Locations
Australia
Investigational Site (410)
RECRUITING
Box Hill
Investigational Site (519)
RECRUITING
Concord
Investigational Site (517)
COMPLETED
Douglas
Investigational Site (413)
RECRUITING
Liverpool
Investigational Site (407)
RECRUITING
West Perth
Investigational Site (409)
RECRUITING
Westmead
Austria
Investigational Site (434)
RECRUITING
Vienna
Canada
Investigational Site (406)
RECRUITING
Greenfield Park
Investigational Site (403)
RECRUITING
Hamilton
Investigational Site (444)
RECRUITING
Toronto
Germany
Investigational Site (438)
RECRUITING
Essen
Italy
Investigational Site (432)
RECRUITING
Meldola
Investigational Site (428)
RECRUITING
Milan
Investigational Site (431)
ACTIVE_NOT_RECRUITING
Novara
Investigational Site (443)
ACTIVE_NOT_RECRUITING
Trieste
Norway
Investigational Site (433)
RECRUITING
Grålum
Investigational Site (437)
RECRUITING
Trondheim
Spain
Investigational Site (436)
RECRUITING
Barcelona
Investigational Site (429)
RECRUITING
Burgos
Investigational Site (430)
RECRUITING
Madrid
Investigational Site (426)
RECRUITING
Murcia
Investigational Site (427)
RECRUITING
Seville
Turkey
Investigational Site (415)
COMPLETED
Ankara
Investigational Site (416)
COMPLETED
Ankara
Investigational Site (418)
COMPLETED
Istanbul
United Kingdom
Investigational Site (442)
RECRUITING
Leeds
Investigational Site (439)
RECRUITING
London
Investigational Site (440)
RECRUITING
London
Investigational Site (441)
RECRUITING
London
Contact Information
Primary
Sarah Murphy
sarah.murphy@iconplc.com
919-786-8898
Time Frame
Start Date: 2023-07-03
Estimated Completion Date: 2027-11
Participants
Target number of participants: 126
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