AzTrials
AzTrials

Systemic SclerosisPhase 2ITS-PILOTNCT03582800

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

A Phase 2 study testing STS in people with Systemic Sclerosis and Dermatomyositis, run by University Hospital, Limoges at 11 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 6 months and older
Conditions the study is for
Systemic Sclerosis, Dermatomyositis, iPPSD2
What is being tested?
STS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
11 sitesFrance
Study dates
6 Jan 2020to 6 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient presenting with:
  • ectopic ossification secondary to iPPSD2 or
  • ectopic calcification secondary to dermatomyositis or
  • ectopic calcification secondary to systemic sclerosis
  • Patient aged 2 years or over
  • Indication of STS infusion validated by a multidisciplinary committee, based on the significant morbidity and/or functional impact of the targeted calcification/ossification
Show all 11Show fewer
  • Patient with no planned surgery of the calcifications/ossifications for the twelve coming months
  • Women of childbearing potential on highly effective contraception (such as hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence)
  • Men with women of childbearing potential partners should use condoms during the whole treatment period and until 91 days after the last injection.
  • Informed consent signed by the patient / parents
  • Patient affiliated to the social security system

Who cannot join

  • Allergy to STS or one of the excipients used
  • Contraindication to local injection of STS
  • Anticoagulant therapy
  • Pregnant, parturient or breastfeeding woman
  • Patient deprived of freedom by a court judgment or an administrative decision
  • Patient undergoing psychiatric care under coercion
Show all 9Show fewer
  • Legally protected adult patients (guardianship / curatorship)
  • Patient unable to give consent
  • Patient placed under judicial protection

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vincent GUIGONIS, MD contact

555056358 ext. +33

vincent.guigonis@unilim.fr

Claire BAHANS contact

claire.bahans@chu-limoges.fr

11 sites in 1 country

France11 sites, 11 recruiting

  • CHU de BORDEAUX

    Bordeaux, 33000

    Marie-Elise TRUCHETET, MD, marie-elise.truchetet@chu-bordeaux.fr

    Marie-Elise TRUCHETET, MD

    Recruiting

  • Hospice Civil de Lyon

    Bron, 69500

    Justine BACCHETTA, MD, justine.bacchetta@chu-lyon.fr

    Justine BACCHETTA, MD

    Recruiting

  • ApHp - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270

    Agnès LINGLART, MD, agnes.linglart@aphp.fr

    Agnès LINGLART, MD

    Recruiting

  • CHU de Limoges

    Limoges, 87042

    Vincent GUIGONIS, MD, vincent.guigonis@unilim.fr

    Claire BAHANS, claire.bahans@chu-limoges.fr

    Recruiting

  • ApHp - hôpital Lariboisière

    Paris, 75000

    Korng EA, MD, korngea@yahoo.fr

    Korng EA, MD

    Recruiting

  • Hôpital Cochin

    Paris, 75000

    Benjamin CHAIGNE, MD, +33 158412143, benjamin.chaigne@aphp.fr

    Benjamin CHAIGNE, MD

    Recruiting

  • Hôpital de la Pitié Salpétriêre

    Paris, 75651

    Olivier BENVENISTE, MD, +33142161088, olivier.benveniste@aphp.fr

    olivier BENVENISTE, MD

    Recruiting

  • CHU de RENNES

    Rennes, 35200

    Marie-Béatrice SAADE, MD, +33 299267134, marie-beatrice.saade@chu-rennes.fr

    Marie-Béatrice SAADE, MD

    Recruiting

  • CHU de ROUEN

    Rouen, 76031

    Mireille CASTANET, MD, 232880250 ext. +33, mireille.castanet@chu-rouen.fr

    Mireille CASTANET, MD

    Recruiting

  • CHU de Toulouse

    Toulouse, 31000

    Valérie PORQUET-BORDES, MD, porquet-bordes.v@chu-toulouse.fr

    Valérie PORQUET-BORDES, MD

    Recruiting

  • CHU de Toulouse - Hôpital Larrey

    Toulouse, 31059

    Chloé CHALLAMEL, MD, +33 567771408, challamel.c@chu-toulouse.fr

    Chloé CHALLAMEL, MD

    Recruiting

Other trials in France

About this study

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).

Being tested
STS
Keywords
Sodium thiosulfate, Ectopic calcification, Ectopic Ossification
Medical subject headings
Scleroderma, Systemic, Dermatomyositis, Ossification, Heterotopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STSDrug

    M0-M6 (run-in phase): medical care and follow-up as usual

    M6-M12 (STS phase):

    • Patients with iPPSD2 will be treated with subcutaneous infusion using a portable pump.
    • Patients with dermatomyositis or systemic sclerosis will be treated with repeated injections every two weeks.

    Patients will receive a maximal total number of 11 STS injections. M12: final visit (V5): clinical evaluation, photograph and CT scan of the treated lesion, pain and quality of life evaluation.

Study groups in NCT03582800
Study groupRoleWhat they receive
TreatedExperimentalM0-M6: run-in phase (control) M6-M12: STS treatment phase
Receives: Drug: STS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of the percentage of volume of the treated calcifications / ossifications

    Calculation of percentage of volume evolution of the treated calcification / ossification between the beginning and the end of STS treatment, in each of the three diseases (dermatomyositis, systemic sclerosis and iPPSD2), evaluated on CT-scan measurements.

    Measured: between Month 6 and Month 12

Secondary outcomes (7)

  1. Change of the volume of the treated calcifications / ossifications

    Calculation of volume of the treated calcification / ossification at (i) inclusion, the end of the run-in period (6 month) and after 6 months of local injections of STS in each disease (12 month), evaluated on CT-scan measurements.

    Measured: Month 0, Month 6 and Month 12

  2. Adverse events

    Collection of adverse events (clinical and biological): causality, severity, and seriousness during the STS treatment.

    Measured: Month 12

  3. Change of the Hounsfield density of the treated ectopic calcifications/ossifications

    Hounsfield density analysis of the treated ectopic calcifications/ossifications at inclusion, the end of the run-in period (6 month) and after 6 months of local injections of STS (12 month), evaluated on CT-scan measurements.

    Measured: Month 0, Month 6 and Month 12

  4. Change of the percentage of patient with a clinically pertinent variation in pain

    Calculation of Percentage of patients with a clinically pertinent variation in pain evaluated with pain scales: difference in hetero-evaluation scale of pain in children (HEDEN) ≥ 2 (2-7 years old) between M0-M6 and M6-M12

    Measured: Between Month0 and Month 6 and Between Month 6 and Month 12

  5. Change of the percentage of patient with a clinically pertinent variation in pain

    Calculation of Percentage of patients with a clinically pertinent variation in pain evaluated with pain scales: difference in visual analogue pain intensity scale (VAS) score ≥ 2 (> 7 years old) between M0-M6 and M6-M12

    Measured: Between Month0 and Month 6 and Between Month 6 and Month 12

  6. Change of the percentage of patients with a clinically pertinent variation in quality of life

    Calculation of percentage of patients with a clinically pertinent variation in quality of life : difference in PedsQL ≥ 5 (2-18 years old, using appropriates reports) between M0-M6 and M6-M12

    Measured: Between Month0 and Month 6 and Between Month 6 and Month 12

  7. Change of the percentage of patients with a clinically pertinent variation in quality of life

    Calculation of percentage of patients with a clinically pertinent variation in quality of life : difference in Short Form 36 (SF36) score ≥ 20 (> 18 years old) between M0-M6 and M6-M12

    Measured: Between Month0 and Month 6 and Between Month 6 and Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2018
  2. Study start6 Jan 2020
  3. Primary completion6 Jun 2029 (estimated)
  4. Study completion6 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03582800
Sponsor's protocol ID
I17004 (ITS-PILOT)
Acronym
ITS-PILOT
Status last verified
Sep 2026
First submitted
13 Jun 2018
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing STS in people with Systemic Sclerosis and Dermatomyositis, run by University Hospital, Limoges at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vincent GUIGONIS, MD (555056358 ext. +33, vincent.guigonis@unilim.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the percentage of volume of the treated calcifications / ossifications (time frame: between Month 6 and Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03582800.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in