Two prednisolone tapering plans for people with stable sarcoidosis

Corticosteroid Tapering in Sarcoidosis

The team will try two different prednisolone tapering plans to see if people with stable sarcoidosis taking 5–10 mg/day can safely cut their dose by at least half.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Royal Brompton & Harefield NHS Foundation Trust (Academic / other)
• Drugs / interventions: infliximab
• Locations: 1 site (London)
• Trial ID: NCT07498842 on ClinicalTrials.gov

What this trial studies

This randomized study at the Royal Brompton Hospital enrolls adults with confirmed, clinically stable sarcoidosis who have been on prednisolone 5–10 mg/day for more than six months. Participants are assigned to a standard taper (slower reductions with step-downs to 1 mg changes over weeks) or a faster taper (more frequent 1 mg reductions with phone support every two weeks). Both arms measure serum cortisol at 3 mg/day to guide further tapering and monitor for adrenal insufficiency or flare. The primary aim is to determine whether participants can reduce prednisolone to at least 50% of their baseline dose without clinical deterioration.

Who should consider this trial

Good fit: Adults (≥18) with confirmed sarcoidosis who have been clinically stable for >6 months and are taking prednisolone 5–10 mg/day for >6 months, and who do not have cardiac/neurosarcoidosis, advanced pulmonary disease, active flare, adrenal insufficiency, pregnancy/breastfeeding, or prior/current infliximab use.

Not a fit: Patients with cardiac or neurosarcoidosis, advanced pulmonary sarcoidosis, recent flares or dose escalation, known adrenal insufficiency, pregnancy or breastfeeding, or prior/current infliximab are excluded and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could allow patients to lower steroid exposure and reduce long-term side effects such as diabetes, weight gain, high blood pressure, and bone loss.

How similar studies have performed: Randomized comparisons of tapering speed in sarcoidosis are limited, so this pragmatic head-to-head comparison is relatively novel though steroid tapering is a common clinical practice.

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

Where this trial is running

London

• Royal Brompton Hospital — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Vasileios Kouranos — Interstitial Lung Disease Department, Royal Brompton Hospital
• Study coordinator: Vasileios Kouranos

Conditions Sarcoidosis; corticosteroid tapering