An explorative clinical study to assess the potential of intravenously administered sodium thiosulfate in subjects with primary Raynaud’s phenomenon

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

24 Oct 2025 → ongoing

Decision date (initial)

2025-09-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

TS Vascular BV

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Pharmacodynamic, Safety

To determine the effect of increasing doses of intravenously administered STS on the magnitude of vasodilatation in subjects with Raynaud’s phenomenon

Secondary objectives 4

1. To determine TS pharmacokinetics after increasing intravenous doses of STS
2. To determine the effect of increasing doses of intravenously administered STS on the magnitude of a simulated cold-induced Raynaud’s attack
3. To determine the safety and tolerability of increasing doses of intravenously administered STS
4. To explore and compare the pharmacodynamics of increasing doses of intravenously administered STS

Conditions and MedDRA coding

Raynaud’s phenomenon

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Age 18-45
2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
3. Female or male
4. No clinically significant abnormality on 12-lead ECG performed at screening
5. Willing to comply with all study related procedures and restrictions;
6. Subject is a non-smoker or previous smoker who stopped smoking more than 3 months ago;
7. Subjects must have an estimated glomerular filtration rate (eGFR) corrected for their body surface area of ≥90 mL/min based on the CKD-EPI equation, with a single repeat permitted to assess eligibility, if needed;
8. All prescribed medication (except for oral contraceptives) must have been stopped at least 14 days prior to each admission to the clinical research center
9. Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening and each admission to the clinical research center
10. Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) and grapefruit (juice) from 48 hours (2 days) prior to each admission to the clinical research center
11. Diagnosed with primary Raynaud’s phenomenon

Exclusion criteria 15

1. In case of females, subject is pregnant or breast feeding
2. Presence of auto-antibodies associated with secondary causes of Raynaud’s phenomenon;
3. Any secondary disease associated with Raynaud’s phenomenon i.e. systemic autoimmune disease, other structural vascular or systemic diseases associated with Raynaud’s;
4. Any invasive radiological, anesthesiologic or surgical procedure performed for Raynaud’s phenomenon
5. History of digital ulcers
6. History of severe trauma to forearm, hands and fingers
7. Subject is mentally or legally incapacitated, has significant emotional problems at the time of screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last year;
8. Subject is unable to refrain from or anticipates the use of any medication throughout the study
9. Subject consumes excessive amounts of alcohol, defined as greater than 21 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer (284 mL), wine (125 mL), or distilled spirits (25 mL) per week;
10. Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 3 months prior to the screening visit
11. Unsuitable veins for blood sampling;
12. Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator
13. Presence of abnormal capillary microscopy or other structural vascular abnormalities of forearm, hands, and fingers;
14. Patients with concomitant cardiovascular disease like hypertension and previous cerebrovascular events
15. Asthma patients

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. For each treatment:area under the cooling and rewarming curve (AUC) and mean ischemic time of one hand assessed by cooling and recovery photo-electric plethysmography (PPG, BIOPAC)
2. For each treatment: regions of interest peripheral blood perfusion of same hand by FLIR thermography system (FLIR E53)

Secondary endpoints 11

1. Pharmacokinetics: Determination and comparison of AUC0-t, AUC0-inf Cmax after increasing dose regimens of intravenously administered STS
2. Pharmacokinetics: Determination and comparison of steady-state levels after increasing dose regimens of intravenously administered STS
3. Pharmacokinetics: Determination and comparison of elimination PK parameters after increasing dose regimens of intravenously administered STS
4. Pharmacokinetics: Determination of endogenous STS levels (based on various pre-dose levels) in Raynaud’s patients
5. Safety and tolerability as evidenced by: Incidence of treatment-emergent adverse events (TEAEs)
6. Safety and tolerability as evidenced by: ECG
7. Safety and tolerability as evidenced by: Continuous blood pressure measurement (Finapress)
8. Safety and tolerability as evidenced by: Local tolerability at vein of intravenous administration
9. Pharmacodynamics: Oxidative stress (systemic free thiols, plasma malondialdehyde (MDA))
10. Pharmacodynamics: Inflammation (circulating pro-inflammatory cytokines e.g. IL-6, IL-1 beta and TNFalpha)
11. Pharmacodynamics: Endothelial activation (circulating adhesion molecules)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

dr. Udo Mulder

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

dr. Udo Mulder

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications