BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)

A Phase Ib, Multicentre, Randomised, Double-blind, Placebo Controlled, 8 Week Crossover Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered BI 705564 in Patients With Systemic Lupus Erythematosus.

NCT03771885•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The main objective of this study is to assess the safety, tolerability and pharmacokinetics of orally administered BI 705564 in patients with systemic lupus erythematosus

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•≥ 18 years at screening.
•Diagnosis of systemic lupus erythematosus (SLE) at least 6 months prior to screening according to SLICC 2012 criteria; at least 4 criteria must be documented.
•Positive test results for anti-nuclear antibody (ANA) (human epithelial cell-2 ANA greater than or equal to \[\>=\] 1:80) and/or anti-dsDNA antibody at the Screening visit. To be performed by Central Laboratory.
•At screening visit a "clinical" Systemic Lupus Erythematosus Disease Activity Index (2K), (SLEDAI 2K) score of ≥ 4 points. The "clinical" score is the SLEDAI 2K assessment score without the inclusion of points attributable to any blood laboratory results including immunologic measures. Neurologic descriptors of the SLEDAI 2K are not counted towards the SLEDAI 2K study entry criteria.
•Has received all scheduled vaccines according to local guidelines and Investigator judgement. Live or live-attenuated virus vaccines are not permitted within 1 month prior to screening or during screening. For all other vaccines there must be at least 2 weeks between the vaccination(s) and the date of randomization at Day 1.
•For male patients: Men who are permanently sterile by bilateral orchidectomy are not required to use contraception. Men whose partner (or potential partner) is a women of childbearing potential\*, for the duration of the study (including 30 days after the last dose of study drug) must use a condom. For female patients: Women of childbearing potential\* must be willing and able to use a double-barrier contraception (barrier in the meaning of method) with at least one highly effective method of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration of the study including 4 weeks after the last dose of study drug. Medically accepted methods of contraception in this study are:
•* Combined (oestrogen and progestogen containing) hormonal birth control associated with inhibition of ovulation in combination with male condom.
•* Progestogen-only hormonal birth control associated with inhibition of ovulation in combination with male condom.
•* Intrauterine device (IUD) and intrauterine hormone-releasing system (IUS) in combination with male condom Or
•* The patient must have only vasectomized sexual partner(s) (vasectomy at least 1 year prior to enrolment), Or
+3 more criteria

Exclusion Criteria

•Active clinically significant neuropsychiatric SLE or any BILAG A score for a neuropsychiatric manifestation or in the ophthalmic domain within the past 12 months.
•Drug-induced Lupus.
•Other autoimmune diseases such as Rheumatoid Arthritis, Crohn's, scleroderma, psoriasis, Celiac disease, Graves'disease, thyroid disease, with the following exceptions:
•* Sjögren syndrome if this is secondary to their SLE is permissible.
•* Patients with features of mixed connective tissue disease may be included if this is secondary to their SLE and is, in the Investigator's opinion not considered to be significant.
•* Diabetes if this is considered by the Investigator to be well controlled and there is no evidence of retinopathy or nephropathy.
•Initiation or change in dose of anti-malarial treatment after the screening visit.
•Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin, etc.) or high dose antiplatelet therapy.
•Within 2 weeks prior to Screening or during Screening: use of oral corticosteroids greater than (\>) 15 mg daily prednisone or an equivalent dose, use of any injectable corticosteroids, or change in dose of corticosteroids. For patients continuing on oral corticosteroids the dose must be stable for 4 weeks prior to randomisation.
•After consent, initiation or change in dose of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker.
+31 more criteria

Key Dates

Start Date

March 16, 2019

Primary Completion Date

December 21, 2019

Completion Date

January 7, 2020

Last Updated

November 15, 2021

Conditions

Lupus Erythematosus, Systemic

Interventions

BI 705564

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)

Inclusion Criteria

Exclusion Criteria

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

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