Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
66
Countries
1
Sites
3
Systemic mastocytosis with a slow course and involvement of the skin
Compare the effects of treatment with dupilumab (the study drug) and fexofenadine (standard antihistamine treatment).
Key facts
- Sponsor
- Medical University Of Gdansk
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 15 Oct 2025 → ongoing
- Decision date (initial)
- 2025-03-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Medical Research Agency (Agencja Badań Medycznych)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy
Compare the effects of treatment with dupilumab (the study drug) and fexofenadine (standard antihistamine treatment).
Secondary objectives 1
- 1. Frequency of occurrence of inflammatory symptoms caused by the action of mast cells, mainly anaphylaxis (number of anaphylaxis and redness/week) 2. Assessment of the extent of skin lesions and skin itching 3. Test for serum tryptase concentration and possible liver and spleen enlargement (if present) 4. Improving the quality of life assessment 5. Frequency of symptoms of depression 6. Assessment of fatigue symptoms (Fatigue Impact Scale)
Conditions and MedDRA coding
Systemic mastocytosis with a slow course and involvement of the skin
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10042949 | Systemic mastocytosis | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Diagnosis of systemic mastocytosis with a slow course according to WHO criteria and skin involvement of the above-mentioned. criteria • Age 18-65 lat • There is a moderate additional risk of a disease impairing the quality of life in 2 of 6 abnormalities: 1. Extent of skin lesions - % of skin function (BSA-Body Surface Area according to the Wallace 9 principles); importance of the impact of skin lesions (>=30% BSA) 2. Intensity of itching on the VAS scale assessment of this result on a scale of 0-10 points severe or severe itching >=3 on the VAS scale 3. Quality of life index of the MC-QoL questionnaire (symptoms causing with the release of mast cell mediators) MC-QoL score >=50 points 4. Severity of the score (Hamilton Rating Scale for Depression) Hamilton Rating Scale score >=19 5. Severity determines (Fatigue Impact Scale) Fatigue Impact Scale score >=75 points 6. Assessment of the quality of life of patients treated for hematologic disease using the European Organization for Research and Treatment of Cancer EORTC QLQ C30 questionnaire <= 83 points
Exclusion criteria 1
- • Other cancer diseases, including one of the aggressive forms of mastocytosis, isolated cutaneous mastocytosis (without systemic mastocytosis). • Liver, kidney and heart failure, respiratory failure • Chronic infectious diseases and parasitic infections, pregnancy, lactation, lack of cooperation with the patient. • Exacerbation of chronic diseases. • Hypersensitivity to study drugs
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Reducing the incidence of symptoms caused by the release of mast cell mediators, mainly anaphylaxis (number of anaphylaxis and flushing/week) 2. Reducing the extent of skin lesions (BSA-Body Surface Area assessed according to the principle Nines Wallace) 3. Reduction of itch severity (VAS) 4. Improving the quality of life (MC-QoL, EORTC QLQ C30) 5. Reducing symptoms of depression (Hamilton Rating Scale for Depression) and fatigue (Fatigue Impact Scale)
Secondary endpoints 1
- 1. Quality of Life in Mastocytosis (QLMS) Questionnaire, 2. The incidence of life-threatening anaphylactic reactions, 3. Decreased concentration of tryptase, IL4 and IL13 in peripheral blood serum.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Dupixent 300 mg solution for injection in pre-filled syringe
PRD5521295 · Product
- Active substance
- Dupilumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2700 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- D11AH05 — -
- Marketing authorisation
- EU/1/17/1229/001
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Telfexo 180 mg, tabletki powlekane
PRD444674 · Product
- Active substance
- Fexofenadine Hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 180 mg milligram(s)
- Max total dose
- 20160 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- R06AX26 — FEXOFENADINE
- Marketing authorisation
- 14236
- MA holder
- ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
PRD463376 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 4 ml millilitre(s)
- Max total dose
- 18 ml millilitre(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- R/2484
- MA holder
- ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PL2 - placebo for Telfexo 180 mg
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Gdansk
- Sponsor organisation
- Medical University Of Gdansk
- Address
- Ul. Marii Sklodowskiej-Curie 3a
- City
- Gdansk
- Postcode
- 80-210
- Country
- Poland
Scientific contact point
- Organisation
- Medical University Of Gdansk
- Contact name
- Chief Medical Officer; Principal Investigator
Public contact point
- Organisation
- Medical University Of Gdansk
- Contact name
- Director of Clinical Research Support Centre
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 66 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Uniwersytecki Szpital Kliniczny w Białymstoku
Klinika Alergologii i Chorób Wewnętrznych, ul. Marii Skłodowskiej-Curie 24a, 16-276, Białystok
Uniwersyteckie Centrum Kliniczne
Klinika Alergologii i Pneumonologii, ul. Smoluchowskiego 17, 80-214, Gdańsk
Uniwersytecki Szpital Kliniczny we Wrocławiu
Klinika Chorób Wewnętrznych Pneumonologii i Alergologii, ul. Chałubińskiego 1a, 50-368, Wrocław
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2025-10-15 | 2025-10-21 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Urgent safety measures 1 · Art. 54 CTR
Urgent safety measure US-121457
- Event date
- 2026-03-09
- Submission date
- 2026-03-10
- In response to
- OTHER
- Member states affected
- Poland
- Event description
- Urgent safety measure implemented following identification of a serious breach potentially impacting participant safety in the MAnaskin clinical trial.
- Measures taken
- Following identification of the serious breach, recruitment and study treatment at the affected site were suspended. The randomisation system was corrected and re-validated, and treatment allocation for affected participants was verified. All affected participants underwent medical assessment to ensure their safety.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protoko Manaskin - clean version final | 2.0 |
| Recruitment arrangements (for publication) | Recruitment Arrangements_MAnaskin | 1.0 |
| Subject information and informed consent form (for publication) | Wzor formularza swiadomej zgody dla pacjenta | 2.0 |
| Subject information and informed consent form (for publication) | Zaacznik nr 3 - Formularz Swiadomej Zgody na Biobankowanie | 2.0 |
| Subject information and informed consent form (for publication) | Zaacznik nr 4 - Formularz Ankiety Uczestnika Badania | 1 |
| Subject information and informed consent form (for publication) | Zaacznik nr 5 - Minimalne warunki biobankowania materiau biologicznego | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | dupixent chpl | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | feksofenadyna chpl | 1 |
| Synopsis of the protocol (for publication) | Streszczenie protokou | 1.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-31 | Poland | Acceptable with conditions 2025-03-03
|
2025-03-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-29 | Poland | Acceptable 2025-06-23
|
2025-06-30 |