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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05757570




Registration number
NCT05757570
Ethics application status
Date submitted
24/02/2023
Date registered
7/03/2023
Date last updated
11/12/2024

Titles & IDs
Public title
An Open-label Study of Povetacicept in Participants With Autoimmune Cytopenias
Scientific title
Open-Label Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Povetacicept in Subjects With Autoimmune Cytopenias (RUBY-4)
Secondary ID [1] 0 0
2023-507067-19-00
Secondary ID [2] 0 0
AIS-D04
Universal Trial Number (UTN)
Trial acronym
RUBY-4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune Thrombocytopenia 0 0
Idiopathic Thrombocytopenic Purpura 0 0
Warm Autoimmune Hemolytic Anemia 0 0
Cold Agglutinin Disease 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - povetacicept

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


Treatment: Drugs: povetacicept
Administered by subcutaneous injection every 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability as Assessed by Adverse events (AEs) and Serious adverse events (SAEs)
Timepoint [1] 0 0
Study Day 1 through 30 days after last dose of study drug

Eligibility
Key inclusion criteria
Key

1. Indication-specific Criteria

1. 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
2. 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
3. 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
2. (All indications) If receiving protocol-specified standard-of-care medications, doses must be stable for protocol-specified durations

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Secondary AIHA, CAD, or ITP
2. Treatment with any of the following within the noted period prior to study entry

1. rituximab: <12 weeks
2. IVIg: <4 weeks
3. sutimlimab, any use after initiation of screening is exclusionary
4. plasmapheresis, plasma exchange, or double-filtration plasmapheresis: <8 weeks
5. transfusions with blood, blood products or other rescue medications: <2 weeks
6. splenectomy: <12 weeks
7. other immunomodulatory or investigational agents, except for investigational agents for COVID-19 that have been granted emergency use authorization or approved by the applicable national health authority: <5 half-lives and requires agreement of the Medical Monitor
3. Recent serious or ongoing infection; risk or history of serious infection

Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2027
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Investigational Site (413) - Liverpool
Recruitment hospital [2] 0 0
Investigational Site (409) - Westmead
Recruitment hospital [3] 0 0
Investigational Site (517) - Douglas
Recruitment hospital [4] 0 0
Investigational Site (410) - Box Hill
Recruitment hospital [5] 0 0
Investigational Site (407) - West Perth
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Austria
State/province [9] 0 0
Vienna
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Germany
State/province [12] 0 0
Essen
Country [13] 0 0
Italy
State/province [13] 0 0
Meldola
Country [14] 0 0
Italy
State/province [14] 0 0
Novara
Country [15] 0 0
Italy
State/province [15] 0 0
Trieste
Country [16] 0 0
Norway
State/province [16] 0 0
Sarpsborg
Country [17] 0 0
Norway
State/province [17] 0 0
Trondelag
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Spain
State/province [20] 0 0
Murcia
Country [21] 0 0
Spain
State/province [21] 0 0
Seville
Country [22] 0 0
Turkey
State/province [22] 0 0
Ankara
Country [23] 0 0
Turkey
State/province [23] 0 0
Istanbul
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Leeds
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alpine Immune Sciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Allison Naumovski
Address 0 0
Alpine Immune Sciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Murphy
Address 0 0
Country 0 0
Phone 0 0
919-786-8898
Fax 0 0
Email 0 0
sarah.murphy@iconplc.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05757570