In short
Clinical trials are studying Sodium Thiosulfate Pentahydrate in people with ectopic calcifications, ectopic ossifications, and primary Raynaud’s phenomenon. These studies aim to evaluate whether treatment can improve the targeted condition and how the body responds over time. The trials include adults with these specific diseases and are in Phase 2.
Key points
- Clinical trials of Sodium Thiosulfate Pentahydrate are studying two main groups of conditions: ectopic calcifications or ossifications, and primary Raynaud’s phenomenon. Both studies are Phase 2 and are authorised. One trial gives the treatment by subcutaneous injection and measures changes in tissue volume on CT scans. The other gives it by intravenous administration and measures blood flow and recovery during cooling tests. Together, these trials focus on how well the treatment may work in specific patient groups.
Trial overview
Two authorised Phase 2 clinical trials are investigating Sodium Thiosulfate Pentahydrate. One trial studies people with ectopic calcifications or ectopic ossifications, and the other studies people with primary Raynaud’s phenomenon.
Study in calcifications and ossifications
NCT03582800 is a pilot study of subcutaneous injections of Sodium Thiosulfate Pentahydrate for ectopic calcifications or ossifications. The trial includes patients with ectopic ossification secondary to iPPSD2, ectopic calcification secondary to dermatomyositis, or ectopic calcification secondary to systemic sclerosis.
This study uses a 6-month run-in period, followed by 6 months of treatment with a 10% STS solution injected locally. In simple terms, the researchers first observe the condition, then give the study treatment to see whether the abnormal calcium or bone changes improve.
Study in primary Raynaud’s phenomenon
The second study, 2023-509432-25-00, is an explorative clinical study in subjects with primary Raynaud’s phenomenon. It looks at the potential of intravenously administered Sodium Thiosulfate Pentahydrate, meaning the treatment is given into a vein.
The brief summary says the study is designed to determine the effect of increasing doses on the magnitude of vasodilatation, which means how much the blood vessels widen. This is important because Raynaud’s phenomenon affects blood flow in the hands.
What the trials measure
The calcification and ossification trial measures the percentage change in volume of treated lesions between month 6 and month 12, using CT-scan measurements. A lesion is the area being treated or studied.
The Raynaud’s trial measures the area under the cooling and rewarming curve and the mean ischemic time of one hand using photo-electric plethysmography, or PPG. It also measures peripheral blood perfusion in the same hand using a FLIR thermography system.
These endpoints help researchers see whether the treatment changes tissue size in one study and blood flow in the other.
Who can participate
The first trial is for patients with ectopic ossification secondary to iPPSD2, or ectopic calcification secondary to dermatomyositis or systemic sclerosis. The second trial is for subjects with primary Raynaud’s phenomenon.
These trials are focused on specific patient groups, so not everyone with a similar symptom would qualify.
Study design and phases
Both studies are interventional, which means the researchers give a treatment and then measure the results. Both are in Phase 2 and are authorised.
The first study plans to enroll 40 people, and the second plans to enroll 12 people. The first uses subcutaneous injections, while the second uses intravenous administration.