Steroid withdrawal in SLE

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Ospedaliero Universitaria Pisana

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

20 Nov 2024 → ongoing

Decision date (initial)

2024-11-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518580-35-00

EudraCT number

2020-002052-21

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To test whether in SLE patients, who are in LLDAS and on background standard-of-care (SoC) therapy, GC withdrawal is non-inferior to low GC dose maintenance for maintaining LLDAS at 36 months of follow-up

Secondary objectives 1

1. 1. To test whether GC withdrawal is not inferior to low GC dose maintenance for maintaining remission at 12, 24 and 36 months of follow-up 2. To evaluate the effect of GC withdrawal compared with low GC dose maintenance on SLE disease activity at 12 , 24 and 36 months of follow-up 3. To evaluate the effect of GC withdrawal compared with low GC dose maintenance on disease flares by 12, 24 and 36 months 4. To evaluate the effect of GC withdrawal compared with low GC dose maintenance in Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) damage index total score at 12, 24 and 36 months. 5. To evaluate and compare quality of life of patients achieving GC withdrawal compared with those in low GC dose maintenance using both disease specific (LIT, LupusQOL) and general questionnaires (FACIT, EQ-5D-3L, SF-36) at 12, 24 and 36 months. 6. To evaluate cost and the cost-effectiveness of GC withdrawal compared with low GC dose maintenance from both the perspective of the National Health System and the Society.

Conditions and MedDRA coding

Systemic Lupus Erythematosus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Type of Patient and Disease Characteristics [1] Are at least 18 years of age to 75 years. [2] Are classified as having SLE according to the EULAR/ACR 2019 criteria [3] Have stable immunosuppressive treatment for SLE for a minimum of 4 months. [4] Fulfilling criteria for a minimum of 6 months prior to the screening visit of the “modified LLDAS” defined as follow: a) SLEDAI-2K≤4 (total, including serology), with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis and fever) and no haemolytic anaemia or gastrointestinal activity; b) no new features of lupus disease activity compared with the previous assessment; c) PhGA (0–3)≤1; d) well-tolerated standard maintenance dosages of immunosuppressive drugs and approved biologics. e) Have a stable treatment with prednisone (or equivalent) dosage≤5 mg/day for a minimum of 6 months [5] Have a stable treatment with antimalarials for SLE (unless contraindicated or not tolerated) for a minimum of six months. [6] have a proven adherence to HCQ (defined as blood levels ≥500 ng/mL at screening) [7] signed informed consent

Exclusion criteria 1

1. 10. Have a concomitant ongoing condition (e.g. asthma, Crohn’s disease) that require treatment with systemic GC (excluding topical or inhaled GC). 11. Not being on antimalarials 12. History of poor adherence to antimalarials 13. Have a concomitant, uncontrolled fibromyalgia with chronic pain (VAS score >7 on a 1-10 scale) 14. Are nursing mothers, pregnant women or women planning to become pregnant during the study. 15. History (either by medical record or subject interview) of intolerance or a contraindication antimalarials. 16. In the opinion of the investigator, are at an unacceptable risk for participating in the study 17. Have a history of intravenous drug abuse, other illicit drug abuse, or chronic alcohol abuse within the 2 years prior to screening or are concurrently using, or expected to use during the study, illicit drugs (including marijuana). 18. Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients maintaining modified LLDAS for 100% of the follow-up period (36 months) even after glucocorticoid withdrawal

Secondary endpoints 1

1. o Proportion of patients who maintain modified LLDAS for 100% of the visits at 12, 24 and 36 months o Proportion of patients who maintain remission on treatment for 100% of the visits at 12, 24 and 36 months

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Ospedaliero Universitaria Pisana

Sponsor organisation

Azienda Ospedaliero Universitaria Pisana

Address

Via Roma 67

City

Pisa

Postcode

56126

Country

Italy

Scientific contact point

Organisation

Azienda Ospedaliero Universitaria Pisana

Contact name

Clinical Trial Center

Public contact point

Organisation

Azienda Ospedaliero Universitaria Pisana

Contact name

Clinical Trial Center

Locations

1 EU/EEA country · 5 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 7 files

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

Application history

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