Clinical trial • Phase IV • Immunology | Haematology

POVETACICEPT for Autoimmune cytopenias | Warm autoimmune hemolytic anemia | Cold agglutinin disease | Immune thrombocytopenia

Phase IV trial of POVETACICEPT for Autoimmune cytopenias | Warm autoimmune hemolytic anemia | Cold agglutinin disease | Immune thrombocytopenia.

Overview

Trial Therapeutic Area
Immunology | Haematology
Trial Disease
Autoimmune cytopenias | Warm autoimmune hemolytic anemia | Cold agglutinin disease | Immune thrombocytopenia
Trial Stage
Phase IV
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
30-11-2023
First CTIS Authorization Date
15-04-2024

Trial design

Randomised, open-label, none/not specified-controlled, adaptive Phase IV trial in Germany, Norway, Austria and others.

Randomised
Yes
Open Label
Yes
Comparator
None/Not specified
Adaptive
True - interim analysis after first 7 subjects in each cohort treated with 3 cycles (12 weeks) to assess safety/efficacy and determine stopping for futility or lack of efficacy; Part 2 may include dose selection/levels based on emerging data (potential lower dose and/or 240 mg Q4W).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
92
Trial Duration For Participant
224

Eligibility

Recruits 92 Vulnerable populations selected (isVulnerablePopulationSelected = true). Subject Information Sheets and Informed Consent Forms are listed in the record (language- and country-specific versions), but specific consent/assent handling details are not provided in the available JSON..

Vulnerable Population
Vulnerable populations selected (isVulnerablePopulationSelected = true). Subject Information Sheets and Informed Consent Forms are listed in the record (language- and country-specific versions), but specific consent/assent handling details are not provided in the available JSON.

Inclusion criteria

  • {"criterion_text":"- Indication-specific Criteria a. Immune Thrombocytopenia (ITP) * Documented persistent or chronic primary ITP of at least 12 weeks duration * History of failure or relapse to at least 2 treatment regimens for ITP * A documented history of response to IVIg or steroids * History of exposure to a TPO-RA unless otherwise contraindicated or unavailable * Documented history of platelets <30 × 10^9/L b. 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 LLN (iii) lactate dehydrogenase >ULN * History of failure or relapse to at least 2 treatment regimens for wAIHA c. 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: (i) indirect bilirubin>ULN and (ii) lactate dehydrogenase >ULN or haptoglobin"}
  • {"criterion_text":"- (All indications) If receiving protocol-specified standard-of-care medications, doses must be stable for protocol-specified durations"}
  • {"criterion_text":"- Indication-specific Criteria for Warm Autoimmune Hemolytic Anemia (wAIHA) and Cold Agglutinin Disease (CAD): Documentation of folic acid and vitamin B12 within normal ranges"}

Exclusion criteria

  • {"criterion_text":"- Secondary AIHA, CAD, or ITP"}
  • {"criterion_text":"- Treatment with any of the following within the noted period prior to study entry a. rituximab: <12 weeks b. IVIg: <4 weeks c. sutimlimab: any use after initiation of screening is exclusionary, other marketed biologic therapeutics: <8 weeks d. plasmapheresis, plasma exchange, or double-filtration plasmapheresis: <8 weeks e. transfusions with blood, blood products or other rescue medications: 2 weeks f. splenectomy: <12 weeks g. 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"}
  • {"criterion_text":"- Recent serious or ongoing infection; risk or history of serious infection."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Type, incidence, severity, and seriousness of AEs.","definition_or_measurement_approach":"Not specified in the available record"}

Secondary endpoints

  • {"endpoint_text":"- Assessment of efficacy, PK, and ADA","definition_or_measurement_approach":"Not specified in the available record"}

Recruitment

Planned Sample Size
92
Recruitment Window Months
27
Consent Approach
Informed consent obtained via site-specific Subject Information Sheets and Informed Consent Forms (multiple L1_SIS and ICF documents listed, including language-specific versions). The JSON lists ICF documents for pregnant participants/partners and optional sample storage; specific age-based consent/assent procedures and languages offered are not detailed in the available record.

Geography

Total Number Of Sites
13
Total Number Of Participants
34

Germany

Earliest CTIS Part Ii Submission Date
26-02-2024
Latest Decision Or Authorization Date
17-04-2024
Processing Time Days
51
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Hämatologie und Stammzelltransplantation
Principal Investigator Name
Alexander Röth
Principal Investigator Email
studienzentrumhaemaSZT@ukessen.de
Contact Person Name
Alexander Röth
Number Of Participants
2

Norway

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
17-05-2024
Processing Time Days
60
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Sykehuset Oestfold HF Kalnes
Department Name
Hematology
Contact Person Name
Waleed Ghanima
Contact Person Email
waleed.ghanima@medisin.uio.no
Site Name
St. Olavs Hospital HF
Department Name
Hematology
Contact Person Name
Henrik Hjorth-Hansen
Contact Person Email
henrik.hjorth-hansen@stolav.no

Austria

Earliest CTIS Part Ii Submission Date
19-03-2024
Latest Decision Or Authorization Date
22-04-2024
Processing Time Days
34
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Clinical Pharmacology
Contact Person Name
Bernd Jilma
Contact Person Email
Bernd.jilma@meduniwien.ac.at

Spain

Earliest CTIS Part Ii Submission Date
28-03-2024
Latest Decision Or Authorization Date
15-04-2024
Processing Time Days
18
Number Of Sites
5
Number Of Participants
14

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Hematology
Contact Person Name
Cristina Pascual Izquierdo
Contact Person Email
cpascuali@salud.madrid.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Contact Person Name
Maria Eva Mingot Castellano
Site Name
Hospital General Universitario Morales Meseguer
Department Name
Hematology
Contact Person Name
Maria Luisa Lozano Almela
Contact Person Email
mllozano@um.es
Site Name
Hospital Universitario De Burgos
Department Name
Hematology
Contact Person Name
Tomas Jose Gonzalez Lopez
Site Name
Hospital Del Mar
Department Name
Hematology
Contact Person Name
Blanca Sanchez Gonzalez
Contact Person Email
97894@parcdesalutmar.cat

Italy

Earliest CTIS Part Ii Submission Date
29-02-2024
Latest Decision Or Authorization Date
17-04-2024
Processing Time Days
49
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
SCDU Ematologia
Contact Person Name
Andrea Patriarca
Contact Person Email
andrea.patriarca@uniupo.it
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
SC UCO Ematologia
Contact Person Name
Francesco Zaja
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncologia Medica
Contact Person Name
Alessandro Lucchesi
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Ematologia
Contact Person Name
Bruno Fattizzo

Sponsor

Primary sponsor

Full Name
Alpine Immune Sciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
4g Clinical LLC / 4G Clinical B.V.
Responsibilities
sponsorDuties code: 3 (as listed in record)
Name
PPD International Holdings LLC / Pharmaceutical Product Development LLC
Responsibilities
Site services / trial support (sponsorDuties code: 4)
Name
Confidence Pharmaceutical Research LLC
Responsibilities
Multiple operational duties (sponsorDuties codes: [1,12,13,5,8])

Third parties

  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Confidence Pharmaceutical Research LLC","duties_or_roles":"sponsorDuties codes: [1,12,13,5,8]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes/values: [15: Database URL Licensing and hosting, 6]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Sanquin Diagnostiek B.V.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC (Richmond address)","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC (Highland Heights address)","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties codes/values: [14, 15: IP Distribution]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Telerx Marketing Inc.","duties_or_roles":"sponsorDuties codes/values: [15: AE Case Processing and Responsible Person for EudraVigilance, 8]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Povetacicept Injection
Active Substance
POVETACICEPT
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous injection
Route
Subcutaneous injection
Authorisation Status
Investigational (Test product in trial record)
Dose Levels
240 mg Q4W; potential lower dose level (not specified)
Frequency
Every 4 weeks (Q4W)
Maximum Dose
240 mg
Dose Escalation Increase
Initial dose not specified; following/target dose 240 mg

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