Sodium thiosulfate for Calcinosis cutis | Systemic sclerosis

Inclusion criteria

• {"criterion_text":"- SSc fulfilling ACA/EULAR 2013 criteria as well as patients with positive U1RNP and mixed connective tissue disease with overlap syndrome to SSc\n- Provides signed, written informed consent\n- Above 18 and under 90 years of age at baseline\n- Legally competent, able to give verbal, written and informed consent\n- Communicate in Danish verbally as well as in writing\n- Subject in good general health and willing to participate\n- Is willing and able to comply with the requirements of the protocol and to undergo all testing\n- Medications for SSc are stable for at least 6 weeks prior to study entry\n- If subjects received STS treatment on the selected lesion before, a washout period of 3 months must be complete upon study entry"}

Exclusion criteria

• {"criterion_text":"- Individuals with other skin diseases in the skin area of interest\n- Individuals with CC of other causality\n- Individuals whose CC lesion is not accessible for imaging e.g., inside the ear, inside nostrils.\n- Pregnancy\n- Breastfeeding\n- Women of child-bearing potential not using a contraceptive agent at the time of inclusion\n- Known hypersensitivity to STS"}

Primary endpoints

• {"endpoint_text":"- Complete remission of CC from week 0 to week 28 [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ] defined as removal of total calcinosis volume in scans and/or clinical complete clearance","definition_or_measurement_approach":"Defined as removal of total calcinosis volume in scans and/or clinical complete clearance; assessed at Week 1, Week 5, Week 17, Week 21, Week 28."}
• {"endpoint_text":"- Partial remission of CC from week 0 to week 28 [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ] defined as partial removal of calcinosis volume in scans and/or clinical improvement in PtGA score","definition_or_measurement_approach":"Defined as partial removal of calcinosis volume in scans and/or clinical improvement in Patient Global Assessment (PtGA) score; assessed at Week 1, Week 5, Week 17, Week 21, Week 28."}

Secondary endpoints

• {"endpoint_text":"- Assessment of treatment efficacy of intralesional STS [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ]","definition_or_measurement_approach":"Efficacy assessment of intralesional sodium thiosulfate at specified time points (Week 1, 5, 17, 21, 28)."}
• {"endpoint_text":"- Change in CC lesion severity patient- and physician global score, PtGA and PhGA (1-10) [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ]","definition_or_measurement_approach":"Change measured using patient and physician global scores (PtGA and PhGA) on a 1-10 scale at specified time points."}
• {"endpoint_text":"- Change in CC lesion seen on imaging (RCM, DECT, and CBCT): size, density, remission (complete/partial) [ Time Frame: Week 1, week 28 ]","definition_or_measurement_approach":"Imaging-based assessment (RCM, DECT, CBCT) of lesion size, density and remission status at Week 1 and Week 28."}
• {"endpoint_text":"- Comparison of imaging modalities to assess change in CC (RCM, DECT, and CBCT) [ Time Frame: Week 1, week 28 ]","definition_or_measurement_approach":"Comparison of different imaging modalities (RCM, DECT, CBCT) to evaluate changes between Week 1 and Week 28."}
• {"endpoint_text":"- Validation of/comparison to the Radiological scoring system for CC [ Time Frame: Week 1, week 28 ] The Radiological scoring system for CC is a newer scoring system to assess severity of CC affecting the hands in patients with SSc developed by the Scleroderma Clinical Trials Consortium. Currently, no standardised outcomes for CC exist. This novel radiographic scoring system accounts for the area coverage, density, and anatomic location of CC affecting the hands in patients with SSc","definition_or_measurement_approach":"Validation/comparison of imaging results to the Radiological scoring system for CC at Week 1 and Week 28; scoring accounts for area coverage, density and anatomic location."}
• {"endpoint_text":"- Clinical assessment: ulcer size, inflammatory surroundings and clinical photos [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ]","definition_or_measurement_approach":"Clinical assessments including ulcer size, surrounding inflammation and photographic documentation at specified visits."}
• {"endpoint_text":"- Changes in biomarkers, measured by blood and skin analyses (e.g., to evaluate changes due to therapy, or differences between responders and non-responders to therapy) [ Time Frame: Week 1, week 5, week 17, week 28 ]","definition_or_measurement_approach":"Biomarker measurement via blood and skin analyses at specified time points to evaluate therapy-induced changes and differences between responders and non-responders."}
• {"endpoint_text":"- Incidence and severity of adverse events, including laboratory abnormalities, over time [ Time Frame: Week 1, week 5, week 17, week 21, week 28 ]","definition_or_measurement_approach":"Safety monitoring of adverse events and lab abnormalities at scheduled visits."}
• {"endpoint_text":"- QoL outcome: Health Assessment Questionnaire Disability Index (MD-HAQ-) [ Time Frame: Week 1, week 28 ]","definition_or_measurement_approach":"Quality of life assessed using MD-HAQ at Week 1 and Week 28."}
• {"endpoint_text":"- Change in total calcinosis volume and demonstration of PET/MRI imaging of CC lesions [ Time Frame: Week 28 ]","definition_or_measurement_approach":"Measurement of total calcinosis volume and PET/MRI imaging demonstration at Week 28."}

Denmark

Earliest CTIS Part Ii Submission Date

16-05-2024

Latest Decision Or Authorization Date

22-05-2024

Processing Time Days

6

Number Of Sites

2

Number Of Participants

75

Primary sponsor

Full Name

Aarhus Universitetshospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"[{\"id\":641013,\"sponsorDutiesCodes\": [\"4\"]}]","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"[{\"id\":641014,\"sponsorDutiesCodes\": [\"1\"]}]","organisation_type":"Educational Institution"}