NCT03582800: ITS-PILOT

Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study

Recruiting now Phase 2 Last updated 4 April 2025

What this trial tests

Phase 2 trial testing STS in Systemic Sclerosis in 40 participants. Currently enrolling.

Timeline

6 January 2020

Primary endpoint
6 June 2027

6 June 2027

Quick facts

Lead sponsor	University Hospital, Limoges
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	6 January 2020
Primary completion	6 June 2027
Estimated completion	6 June 2027
Sites	8 locations across France

Drugs / interventions tested

• STS — full drug profile →

Conditions studied

• Systemic Sclerosis — all drugs for Systemic Sclerosis →
• Dermatomyositis — all drugs for Dermatomyositis →
• iPPSD2 — all drugs for iPPSD2 →

Sponsor

University Hospital, Limoges

Who can join

6 Months and older, any sex, with Systemic Sclerosis or Dermatomyositis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ectopic soft tissue calcifications or ossifications can complicate the course of numerous diseases; most of them are rare or very rare. Even if the clinical, radiological and pathological presentation of ectopic calcifications and ossifications are different, the same hypotheses are discussed considering their hypothetical pathophysiology. Indeed, high calcium phosphate product, local cellular lesions and abnormal transdifferentiation of mesenchymal cells are regularly evoked when pathophysiology of such calcifications or ossifications are discussed. Apart from several case reports that have not been confirmed so far, no medical treatments are available, leading to significant pain and impairment of quality of life for patients. Therefore, only surgical treatment can be proposed when the volume or the consequences of these calcifications/ossifications become too important.

Sodium thiosulfate (STS) is currently used as a cyanide poisoning antagonist and a chemoprotectant against adverse effects of several chemotherapies such as Cisplatin. Numerous case reports and several studies have revealed the potential interest of STS in the treatment of uremic induced vascular or soft tissues calcifications. Recently, our group has developed an expertise in the use of STS for the treatment of ectopic soft tissue calcifications or ossifications. Considering these promising preliminary data, and their limits, we developed a strategy to treat soft tissue calcifications or ossifications based on a local administration of STS. The first results of this therapeutic strategy are highly promising and the local or systemic safety is satisfactory so far. These preliminary data also reported by others deserve to be confirmed in a prospective study.

We propose in this project to conduct a prospective open controlled phase II trial in order to assess the efficacy and the safety of intralesional administration of STS for the treatment of calcifications secondary to dermatomyositis or systemic sclerosis and ectopic ossifications secondary to pseudo-hypoparathyroidism 1a type (PHP1A/iPPSD2) (inactivating parathyroid hormone / parathyroid-hormone-related peptid (PTH/PTHrP) signalling disorder).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A glance into the future of myositis therapy.
   Chiapparoli I, Galluzzo C, Salvarani C, Pipitone N. · · 2022 · cited 4× · PMID 35634354 · DOI 10.1177/1759720x221100299