| NCT ID | NCT07498842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Brompton & Harefield NHS Foundation Trust |
| Condition | Sarcoidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2027-06-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-03-19 with a primary completion date of 2027-06-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sarcoidosis is an inflammatory condition affecting many different parts of the body but most commonly the lungs. It is not known what causes sarcoidosis. In some patients no treatment is needed but in other patients long term treatment may be required. One of the main medications used to manage this condition is corticosteroids. This medication has been shown to be very effective at reducing inflammation in this condition and many patients often remain on it for months to years. Unfortunately, there are many negative long-term side effects of corticosteroid use. This includes an increased risk of developing diabetes, reduced bone density, weight gain, high blood pressure and low muscle mass. Currently there are no guidelines for how steroids should be weaned in patients who have stable sarcoidosis. The investigators aim to undertake a study at the Royal Brompton Hospital which will be assessing two different steroid tapering regimens which will be allocated to participants in a randomised manner. This will be the first study to directly evaluate different steroid weaning regimens in sarcoidosis patients. The main aim of this study is to determine how many participants can reduce their prednisolone dose to less than 50% from their baseline dose. Additionally, the investigators will be recording how many participants require an increase in dose or an additional medication whilst on the prednisolone weaning regimen. The investigators will also see the tolerability of steroid withdrawal and assess for any symptoms of steroid withdrawal. In a small subset of participants the investigators will assess for any changes in body composition and muscle strength using bioelectrical impedance analysis and isometric muscle testing.
Eligibility Criteria
Inclusion Criteria: * Confirmed sarcoidosis by: (a) Histological diagnosis and/or (b) Multidisciplinary Team (MDT) diagnosis * Prednisolone 5-10mg/day for \> 6 months * Clinically stable disease for \> 6 months (no flares or dose escalation) * On or off second-line agent * \> 18 years old * Written informed consent provided Exclusion Criteria: * Cardiac or neurosarcoidosis * Advanced pulmonary sarcoidosis defined as either: (a) composite physiological index (CPI) \> 40 (b) pulmonary hypertension * Active sarcoidosis flare or dose escalation in the past 6 months * Known adrenal insufficiency * Pregnancy or breastfeeding * Previous or current infliximab use
Contact & Investigator
Vasileios Kouranos
PRINCIPAL INVESTIGATOR
Interstitial Lung Disease Department, Royal Brompton Hospital
Frequently Asked Questions
Who can join the NCT07498842 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sarcoidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07498842 currently recruiting?
Yes, NCT07498842 is actively recruiting participants. Contact the research team at vasileios.kouranos@nhs.net for enrollment information.
Where is the NCT07498842 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07498842 clinical trial?
NCT07498842 is sponsored by Royal Brompton & Harefield NHS Foundation Trust. The principal investigator is Vasileios Kouranos at Interstitial Lung Disease Department, Royal Brompton Hospital. The trial plans to enroll 100 participants.