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RepurpSS-II study
EU CTIS ID: 2024-510904-36-00
What this study is testing
To assess clinical efficacy and safety of Leflunomide/Hydroxychloroquine in pSS patients in a phase IIb placebo-controlled randomized clinical trial at 24 weeks, followed by a single-arm crossover and an open extension (total duration of 48 weeks) and to evaluate the capacity of molecular fingerprints in prediction of therapy response
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women and men, aged 18-75 years
- pSS diagnosed according to the ACR-EULAR 2016 Criteria for pSS
- ESSDAI ≥5
- Use of a reliable method of contraception
- Signed written informed consent
You likely can't join if
- Since LEF has teratogenic effects patients who are pregnant or who are wishing to conceive (also men with a female partner of childbearing age) during or within two years after the study are excluded. During the screenings visit, pregnancy will be excluded in all female patients of childbearing age. The use of reliable contraceptives for the duration of the study up to 2 years after the last study visit is mandatory for all patients (with a partner) of childbearing age.
- Concomitant heart- and inflammatory bowel disease
- Patients suffering from sarcoidosis
- Usage of HCQ or LEF <6 months prior to inclusion
- Usage of conventional and biological DMARDs and dose escalation non-steroidal inflammatory drugs with the exception of a stable dose of non- steroidal inflammatory drugs and a stable, low dose (≤7.5 mg) of oral corticosteroids
- Inadequate mastery of the Dutch language
See the full eligibility criteria
- Women and men, aged 18-75 years
- pSS diagnosed according to the ACR-EULAR 2016 Criteria for pSS
- ESSDAI ≥5
- Use of a reliable method of contraception
- Signed written informed consent
- Since LEF has teratogenic effects patients who are pregnant or who are wishing to conceive (also men with a female partner of childbearing age) during or within two years after the study are excluded. During the screenings visit, pregnancy will be excluded in all female patients of childbearing age. The use of reliable contraceptives for the duration of the study up to 2 years after the last study visit is mandatory for all patients (with a partner) of childbearing age.
- Concomitant heart- and inflammatory bowel disease
- Patients suffering from sarcoidosis
- Usage of HCQ or LEF <6 months prior to inclusion
- Usage of conventional and biological DMARDs and dose escalation non-steroidal inflammatory drugs with the exception of a stable dose of non- steroidal inflammatory drugs and a stable, low dose (≤7.5 mg) of oral corticosteroids
- Inadequate mastery of the Dutch language
- Patients that breastfeed.
- Patients with therapy resistant hypertension are excluded since this might be aggravated by LEF
- In case of maculopathy or retinitis pigmentosa the patient will be excluded from participation. Examination by an ophtalmologist will take place on indication.
- Patients with secondary Sjögren’s Syndrome (Sjögren’s syndrome associated with other connective tissue disease)
- Patients with hepatic or renal impairment
- Patients with a severe infection (including hepatitis B,C or HIV)
- Presence of a malignancy other than mucosa-associated lymphoid tissue lymphoma (MALT lymphoma)
- Significant cytopenia
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.