Recruiting
Phase 2

STS

Sponsor:

Robyn T. Domsic, MD, MPH

Code:

NCT06672822

Conditions

Systemic Sclerosis (SSc)

Dermatomyositis

Mixed Connective Tissue Disease (MCTD)

Calcinosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sodium Thiosulfate (STS)

Study Details

Brief summary:

The specific objective of this study is to perform a small, open-label study to assess the safety and efficacy of intralesional, subcutaneous injection of STS on calcinosis symptoms and lesion size in systemic sclerosis (SSc), mixed connective tissue disease (MCTD) and dermatomyositis (DM) patients. Injection will be guided by ultrasound, lesion size assessed by ultrasound, and symptom burden by patient-reported outcome measures.

Conditions

Systemic Sclerosis (SSc)

Dermatomyositis

Mixed Connective Tissue Disease (MCTD)

Calcinosis

Study ID

NCT06672822

Start date

Mar 17, 2025

Status verified date

May, 2026

Completion date

May 1, 2029

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Clinical diagnosis of systemic sclerosis, mixed connective tissue disease or inflammatory myopathy
  • Must be over 18 years of age
  • Participants must be competent to give informed consent
  • Participants must have radiographic evidence (xray or ultrasound) of calcinosis.
  • Participants must need symptomatic relief

Exclusion Criteria:

• Pregnant women will be excluded

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sodium thiosulfate (STS)

Open label, single-arm, receiving 1-5ml of STS (250mg/ml) sodium thiosulfate (STS) injections to calcinosis lesions.

Interventions

Sodium Thiosulfate (STS)

Depending on the size of the calcinosis lesion, 1-5ml of STS (250mg/ml) will be used for injection under ultrasound guidance.

Primary outcome measure

  • Primary endpoint: Change in size of calcinosis lesion from baseline to 12 weeks [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Maureen M Laffoon, BS

412-648-7874laffoonm@pitt.edu

Locations

UPMC Arthritis and Autoimmunity Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Office Manager

412-647-6700sclerodermaappts@upmc.edu

Research Coordinator

412-648-7871laffoonm@pitt.edu

Principal Investigator:

Robyn T Domsic, MD

More Information

Sponsor

Robyn T. Domsic, MD, MPH

Last update posted

May 5, 2026

Last verified

May, 2026

Keywords

  • calcinosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Robyn T. Domsic, MD, MPH on 2026-05-05.