Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
32
Countries
1
Sites
1
IgG4-related disease
To demonstrate the efficacy of abatacept in reducing the risk of disease recurrence at 48 weeks
Key facts
- Sponsor
- Ospedale San Raffaele S.r.l., Ospedale San Raffaele S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 9 Dec 2024 → ongoing
- Decision date (initial)
- 2024-04-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512863-30-00
- EudraCT number
- 2022-003916-10
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To demonstrate the efficacy of abatacept in reducing the risk of disease recurrence at 48 weeks
Conditions and MedDRA coding
IgG4-related disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Male or female subjects of legal age and able to provide informed consent
- Patients with active IgG4-related disease naive to therapy or relapsing with an IgG4- RD RI > 2
- Achievement of the 2019 ACR/EULAR Classification Criteria of IgG4-related disease.
Exclusion criteria 12
- Malignancy within 5 years
- Chronic or history of recurrent infections over 6 months prior to screening
- Evidence of severe active liver disease unrelated to IgG4RD
- Concomitant uncontrolled disease that would interfere with the study procedures
- Positive HIV, HBV, HCV serology
- Positive quantiferon test
- Inability to be tapered of glucocorticoid therapy by 8 weeks post randomisation
- Prior use of B cell depleting agents within 6 months of enrolment
- Leukopenia, neutropenia, thrombocytopenia, or anemia
- Serum creatinine > 2.0 mg/dL at the time of randomisation.
- Positive pregnancy test at screening or during the study, or breast feeding
- Subjects who do not agree to use methods of contraception.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Reduction of disease recurrence in patients with IgG4-related disease treated with abatacept compared with placebo-treated pazineti
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP149772 · ATC
- Active substance
- Abatacept
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 17.85 mg milligram(s)
- Max total dose
- 17.85 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA24 — ABATACEPT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ospedale San Raffaele S.r.l.
- Sponsor organisation
- Ospedale San Raffaele S.r.l.
- Address
- Via Olgettina 60
- City
- Milan
- Postcode
- 20132
- Country
- Italy
Scientific contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Emanuel Della Torre
Public contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Emanuel Della Torre
Ospedale San Raffaele S.r.l.
- Sponsor organisation
- Ospedale San Raffaele S.r.l.
- Address
- Via Olgettina 60
- City
- Milan
- Postcode
- 20132
- Country
- Italy
Scientific contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Emanuel Della Torre
Public contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Emanuel Della Torre
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 32 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Italy | 2024-12-09 | 2024-12-09 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-29 | Italy | Acceptable 2024-04-10
|
2024-04-16 |