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An Open-label Study of Povetacicept (ALPN-303) in Subjects With Autoimmune Cytopenias (RUBY-4)

Primary Purpose

Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Warm Autoimmune Hemolytic Anemia

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
povetacicept
Sponsored by
Alpine Immune Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease, Autoimmune Cytopenia, Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenic Purpura, Hemolytic Anemia, RUBY4, RUBY-4, Povetacicept, ALPN-303, ALPN303, Autoimmune Hemolytic Anemia, ITP, wAIHA, AIHA, CAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Summary of Key Inclusion Criteria: Indication-specific Criteria Immune Thrombocytopenia (ITP) Documented primary ITP of at least 12 weeks duration 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 ≤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 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 ≤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 CAD (All indications) If receiving standard-of-care medications, doses must be stable for protocol-specified durations Summary of Key Exclusion Criteria: Secondary AIHA, CAD, or ITP Treatment with any of the following within the noted period prior to study entry rituximab: 12 weeks IVIG, sutimlimab, other marketed biologic therapeutics: 8 weeks plasmapheresis, plasma exchange, or double-filtration plasmapheresis: 8 weeks transfusions with blood, blood products or other rescue medications: 2 weeks splenectomy: 12 weeks other immunomodulatory or investigational agents, except for investigational agents for COVID-19 that have been granted emergency use authorization by the applicable national health authority: 5 half-lives and requires agreement of the Medical Monitor Recent serious or ongoing infection; risk or history of serious infection

Sites / Locations

  • Investigational Site (230)Recruiting
  • Investigational Site (401)Recruiting
  • Investigational Site (419)Recruiting
  • Investigational Site (219)Recruiting
  • Investigational Site (402)Recruiting
  • Investigational Site (409)Recruiting
  • Investigational Site (407)Recruiting
  • Investigational Site (403)Recruiting
  • Investigational Site (415)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

povetacicept 240mg

Arm Description

Outcomes

Primary Outcome Measures

Adverse Events
Type, incidence, severity, and seriousness of AEs

Secondary Outcome Measures

Full Information

First Posted
February 24, 2023
Last Updated
August 3, 2023
Sponsor
Alpine Immune Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05757570
Brief Title
An Open-label Study of Povetacicept (ALPN-303) in Subjects With Autoimmune Cytopenias
Acronym
RUBY-4
Official Title
A Phase 1b Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects With Autoimmune Cytopenias (RUBY-4)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
November 2027 (Anticipated)
Study Completion Date
November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alpine Immune Sciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goal of this clinical study is to evaluate povetacicept (ALPN-303) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura, Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease
Keywords
Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia, Cold Agglutinin Disease, Autoimmune Cytopenia, Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenic Purpura, Hemolytic Anemia, RUBY4, RUBY-4, Povetacicept, ALPN-303, ALPN303, Autoimmune Hemolytic Anemia, ITP, wAIHA, AIHA, CAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
povetacicept 240mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
povetacicept
Other Intervention Name(s)
ALPN-303
Intervention Description
Administered by subcutaneous injection every 4 weeks
Primary Outcome Measure Information:
Title
Adverse Events
Description
Type, incidence, severity, and seriousness of AEs
Time Frame
Study Day 1 through 30 days after last dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Summary of Key Inclusion Criteria: Indication-specific Criteria Immune Thrombocytopenia (ITP) Documented primary ITP of at least 12 weeks duration 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 ≤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 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 ≤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 CAD (All indications) If receiving standard-of-care medications, doses must be stable for protocol-specified durations Summary of Key Exclusion Criteria: Secondary AIHA, CAD, or ITP Treatment with any of the following within the noted period prior to study entry rituximab: 12 weeks IVIG, sutimlimab, other marketed biologic therapeutics: 8 weeks plasmapheresis, plasma exchange, or double-filtration plasmapheresis: 8 weeks transfusions with blood, blood products or other rescue medications: 2 weeks splenectomy: 12 weeks other immunomodulatory or investigational agents, except for investigational agents for COVID-19 that have been granted emergency use authorization by the applicable national health authority: 5 half-lives and requires agreement of the Medical Monitor Recent serious or ongoing infection; risk or history of serious infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Murphy
Phone
919-786-8898
Email
sarah.murphy@iconplc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Naumovski
Organizational Affiliation
Alpine Immune Sciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site (230)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site (401)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site (419)
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site (219)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site (402)
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site (409)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site (407)
City
West Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia
Individual Site Status
Recruiting
Facility Name
Investigational Site (403)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site (415)
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

An Open-label Study of Povetacicept (ALPN-303) in Subjects With Autoimmune Cytopenias

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