Corticosteroid Tapering in Sarcoidosis

NCT07498842 | Recruiting DMC

• 1 other identifier: IRAS ID: 367551
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis

Keywords

corticosteroid tapering

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving a prednisolone dose < 50% of baseline dose

  To evaluate the proportion of patients achieving a prednisolone dose ≤50% of baseline utilising two tapering regimens (standard vs. fast) while maintaining clinical stability

  From enrolment to 6 weeks after complete steroid wean or lowest prednisolone dose achieved

Secondary Outcomes (13)

• The need for initiation or escalation of non-steroidal immunosuppressive therapy

  Enrolment to 6 weeks after either complete steroid wean or lowest achieved prednisolone dose

• Number and length of interruptions to prednisolone taper

  Enrolment until 6 weeks following complete steroid wean or lowest achieved prednisolone dose

• Evaluation of changes in quality of life

  See in description as insufficient space for the detail above to be entered in this section

• Proportion of patients with cortisol levels < 25nmol/L at prednisolone dose 3mg/day

  This will be performed 2 weeks after reaching prednisolone dose of 3mg/day

• Assess for symptoms of steroid withdrawal, safety and tolerability with prednisolone weaning

  See in description as insufficient space for the detail above to be entered in this section

Study Arms (2)

Standard prednisolone taper

ACTIVE COMPARATOR

If initial dose of prednisolone \> 5mg/day then dose will be reduced by 2.5mg/day (round to nearest feasible dose) every 4 weeks until reaching 5mg/day. From 5mg/day to reduce by 1mg/day every 6 weeks until 3mg/day. At 3mg/day a serum cortisol will be measured after 2 weeks. If cortisol \> 25nmol/L, then continue with the Meeran prednisolone taper protocol which is reducing by 1mg every 7 days.

Drug: Standard prednisolone taper

Fast prednisolone taper

ACTIVE COMPARATOR

If initial prednisolone dose \> 5mg/day then reduce by 2.5mg/day (round to nearest feasible dose) every 4 weeks until reaching 5mg/day. From 5mg/day to reduce by 1mg every 2 weeks until 3mg/day. At 3mg/day then measure serum cortisol after 2 weeks. If cortisol \> 25nmol/L then continue to taper by 1mg every 2 weeks. In this arm, patients will contacted over the phone every 2 weeks to provide support with the tapering regimen.

Drug: Fast prednisolone taper

Interventions

Standard prednisolone taper DRUG

If initial dose of prednisolone \> 5mg/day then dose will be reduced by 2.5mg/day (round to nearest feasible dose) every 4 weeks until reaching 5mg/day. From 5mg/day to reduce by 1mg/day every 6 weeks until 3mg/day. At 3mg/day a serum cortisol will be measured after 2 weeks. If cortisol \> 25nmol/L, then continue with the Meeran prednisolone taper protocol which is reducing by 1mg every 7 days.

Standard prednisolone taper

Fast prednisolone taper DRUG

If initial prednisolone dose \> 5mg/day then reduce by 2.5mg/day (round to nearest feasible dose) every 4 weeks until reaching 5mg/day. From 5mg/day to reduce by 1mg every 2 weeks until 3mg/day. At 3mg/day then measure serum cortisol after 2 weeks. If cortisol \> 25nmol/L then continue to taper by 1mg every 2 weeks. In this arm, patients will contacted over the phone every 2 weeks to provide support with the tapering regimen.

Fast prednisolone taper

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton Hospital

London, SW36NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Vasileios Kouranos

  Interstitial Lung Disease Department, Royal Brompton Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasileios Kouranos

CONTACT

+44(0) 207 352 8121; vasileios.kouranos@nhs.net

Jessica Raja

CONTACT

jessica.raja2@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): October 18, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)