Overview
Sponsor-declared trial summary
sarcoidosis
- Investigate whether treatment with azithromycin and doxycycline results in a reduction of the inflammatory activity defined by SUVmax in patients with sarcoidosis - Investigate whether treatment of C. acnes related sarcoidosis, defined by presence of C. acnes within and around granulomas, with a combination of azithr…
Key facts
- Sponsor
- Sint Antonius Ziekenhuis Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 13 May 2024 → 18 May 2026
- Decision date (initial)
- 2024-05-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513534-38-00
- EudraCT number
- 2021-003057-29
- ClinicalTrials.gov
- NCT05291468
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
- Investigate whether treatment with azithromycin and doxycycline results in a reduction of the inflammatory activity defined by SUVmax in patients with sarcoidosis
- Investigate whether treatment of C. acnes related sarcoidosis, defined by presence of C. acnes within and around granulomas, with a combination of azithromycin and doxycycline will lead to a significant decrease of inflammatory activity defined by SUVmax.
Secondary objectives 2
- - Determine if treatment with azithromycin and doxycycline results in an increase in lung function, based on FVC, in pulmonary sarcoidosis patients.
- - Monitor quality of life for patients treated with antibiotics compared to patients receiving placebo, measured by King’s Sarcoidosis Questionnaire that is taken at baseline and end of study.
Conditions and MedDRA coding
sarcoidosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- - Biopsy proven sarcoidosis.
- - Inflammatory activity according to FDG-PET scan at baseline
- - SUVmax above 3 in the lung and/or above 5 in mediastinum/hili
- - No treatment indication for the sarcoidosis
Exclusion criteria 4
- - Increased duration of QT interval (>440ms for men and >450ms for women) on ECG
- - Hearing deficits, a possible side-effect of azithromycin use is hearing deficits, although the chance of this is very small
- - Being pregnant or breastfeeding at time of inclusion
- - Use of an investigational drug during the time between FDG-PET scan and screening.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Reduction of sarcoidosis related inflammation.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Azithran 500 mg επικαλυμμένα με λεπτό υμένιο δισκία
PRD3705620 · Product
- Active substance
- Azithromycin
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 13 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01FA10 — AZITHROMYCIN
- Marketing authorisation
- 22260
- MA holder
- SAPIENS PHARMACEUTICALS LTD
- MA country
- Cyprus
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DOXICLAT 100 mg comprimidos recubiertos con película
PRD105956 · Product
- Active substance
- Doxycycline
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01AA02 — DOXYCYCLINE
- Marketing authorisation
- 50.404
- MA holder
- PIERRE FABRE IBERICA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sint Antonius Ziekenhuis Stichting
- Sponsor organisation
- Sint Antonius Ziekenhuis Stichting
- Address
- Koekoekslaan 1
- City
- Nieuwegein
- Postcode
- 3435 CM
- Country
- Netherlands
Scientific contact point
- Organisation
- Sint Antonius Ziekenhuis Stichting
- Contact name
- Montse Janssen Bonas
Public contact point
- Organisation
- Sint Antonius Ziekenhuis Stichting
- Contact name
- Montse Janssen Bonas
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 40 | 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 |
|---|---|---|---|---|---|
| Netherlands | 2024-05-13 | 2026-05-18 | 2026-05-14 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-17 | Netherlands | Acceptable 2024-05-13
|
2024-05-13 |