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TRIAL EVALUATING EFFICACY AND SAFETY OF HYDROXYCHLOROQUINE VERSUS PLACEBO IN EARLY SYSTEMIC SCLEROSIS (SSc)
EU CTIS ID: 2024-516050-22-00
What this study is testing
To evaluate the efficacy and safety of hydroxychloroquine compared to placebo, at the oral dose of 6 mg/kg daily (up to 400 mg/day), in the treatment of early systemic sclerosis (SSc) associated to SSc standard therapies (immunosuppressive and/or vasoactive).
- Therapeutic confirmatory (Phase III)
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
- Diagnosis of SSc according 2013 ACR/EULAR criteria for classification of SSc (van den Hoogen et al, 2013).
- Written Informed Consent (IC)(patient must be able and agree to sign an IC according ICH-GCP guidelines and local laws)
- Age >= 18 years
- Disease duration <= 5 years from the first non-Raynaud’s symptom
- Stable SSc standard treatment within 4 weeks prior to Screening visit
- Subjects naïve to treatment with hydroxychloroquine or who have undergone a wash-out period of at least 16 weeks (approximately 3 half-lives of the drug)
You likely can't join if
- Known hypersensytivity to the study drug (active substance or excipients) or derivatives 4-aminoquinolines
- Deficiency of glucose-6-phosphate dehydrogenase
- Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1
- Pregnant or breast feeding women
- Other contraindicated clinical and / or laboratory conditions
- Age < 18 years
See the full eligibility criteria
- Diagnosis of SSc according 2013 ACR/EULAR criteria for classification of SSc (van den Hoogen et al, 2013).
- Written Informed Consent (IC)(patient must be able and agree to sign an IC according ICH-GCP guidelines and local laws)
- Age >= 18 years
- Disease duration <= 5 years from the first non-Raynaud’s symptom
- Stable SSc standard treatment within 4 weeks prior to Screening visit
- Subjects naïve to treatment with hydroxychloroquine or who have undergone a wash-out period of at least 16 weeks (approximately 3 half-lives of the drug)
- Known hypersensytivity to the study drug (active substance or excipients) or derivatives 4-aminoquinolines
- Deficiency of glucose-6-phosphate dehydrogenase
- Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1
- Pregnant or breast feeding women
- Other contraindicated clinical and / or laboratory conditions
- Age < 18 years
- Body weight < 45 kg
- History of retynopathy and/or maculopathy
- History of severe miopathy (other than SSc related)
- Anticoagulant and/or antiplatelet therapy
- History of periferic neuropathy
- History of hypoglycemia
- History of bradycardia (HR<50) or ventricular arrhythmias
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.
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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.