Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
50
Countries
1
Sites
5
myeloproliferative neoplasms
To demonstrate a decrease in serum calprotectin levels at 3 months in the anakinra arm compared with the standard of care.
Key facts
- Sponsor
- Centre Hospitalier Regional Et Universitaire De Brest
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Decision date (initial)
- 2026-07-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To demonstrate a decrease in serum calprotectin levels at 3 months in the anakinra arm compared with the standard of care.
Secondary objectives 9
- - To determine the proportion of patients improving their level of clinical response to treatment.
- - To describe changes in hematological parameters during follow up
- - To assess changes in symptom severity associated with the disease over time.
- - To describe treatment-related adverse events at 1, 3 and 6 months
- - To assess adherence to treatment regimen
- - To assess improvement in quality of life at 3 and 6 months
- - To assess improvement in the inflammatory biological profile (cytokines) at 3 and 6 months
- - To assess reduction in the allele burden of the driver mutation at 3 and 6 months
- - To assess reduction in fibrosis markers (circulating CD34+ cells) at 3 and 6 months
Conditions and MedDRA coding
myeloproliferative neoplasms
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- - Diagnosis of MPN: PV, ET, or PMF according to WHO criteria
- - Stable cytoreductive therapy for at least 6 months
- - Incomplete hematologic response according to ELN criteria, excluding bone marrow, OR complete hematologic response with anemia in ET, OR persistence of general clinical symptoms (fever, night sweats, pruritus, fatigue > 5/10 on VAS)
- - Adult patient capable of providing informed consent
Exclusion criteria 11
- - Recurrent or poorly controlled infections
- - Thrombocytopenia < 100 G/L
- - Neutropenia < 1 G/L
- - Hypersensitivity to the active substance, any excipients, or proteins derived from Escherichia coli
- - Concomitant immunosuppressive therapy
- - Refusal to participate
- - Patient under legal protection (guardianship, curatorship, etc.)
- - Patients unable to consent.
- - Pregnant or breastfeeding women.
- - Lack of understanding of questionnaires or inability to follow up.
- - Women of childbearing potential unwilling to use appropriate contraception.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Baseline and 3-month serum calprotectin levels.
Secondary endpoints 9
- - Improvement (yes/no) of the response statusresponse status (according to ELN criteria) between baseline-M3, baseline-M6, M3-M6
- - hematological parameters (e.g., hemoglobin, hematocrit, white blood cell count, platelet count) at baseline, 3 and 6 months..
- - Patient-reported symptom severity over the previous 4 weeks assessed using a 10-point Visual Analog Scale (VAS) for pruritus, fever, and night sweats at baseline, 3 and 6 months.
- - Treatment-related adverse events (type and number)
- - Daily self-reported treatment intake (Yes/No) recorded in the patient diary over the 3-month period
- - EORTC QLQ-C30 score at baseline, 3 and 6 months
- - Multiplex assay of inflammatory cytokines at baseline, 3 and 6 months
- - Quantification of JAK2V617F, CALR exon 9, or MPL W515 at baseline, 3 and 6 months
- - Measurement of circulating CD34+ cells at baseline, 3 and 6 months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
PRD1778560 · Product
- Active substance
- Anakinra
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 9 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AC03 — -
- Marketing authorisation
- EU/1/02/203/006
- MA holder
- SWEDISH ORPHAN BIOVITRUM AB (PUBL)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional Et Universitaire De Brest
- Sponsor organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Address
- 2 Avenue Marechal Foch
- City
- Brest
- Postcode
- 29200
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- DOLOU Julien
Public contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- DOLOU Julien
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 50 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Hopital Saint Louis
Investigation et pharmacologie clinique - hématologie, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Regional Universitaire De Tours
Hématologie et thérapie cellulaire, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Des Pays De Morlaix
Onco-Hématologie, 15 Rue De Kersaint Gilly, Bp 97237, Morlaix
Centre Hospitalier Regional Et Universitaire De Brest
Hématologie, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier Regional D'Angers
Maladies du sang, 4 Rue Larrey, 49100, Angers
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-523921-17-00 | 1.1 |
| Protocol (for publication) | D4_Patient Compliance Log | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Subjects | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Addendum_SmPC_INTEREST | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC KINERET | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis EN_2025-523921-17-00 | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis FR_2025-523921-17-00 | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-16 | France | Acceptable 2026-06-08
|
2026-07-02 |