BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)

NCT03771885 | Withdrawn Phase 1

• 2 other identifiers: 1408-00042017-004948-38
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

• The primary endpoint to assess safety and tolerability of BI 705564 is the number of patients with drug related Adverse Events

  Up to 73 Days

Secondary Outcomes (5)

• Number and severity of Adverse Events

  Up to 87 Days

• Number of patients with Adverse Events

  Up to 87 Days

• Number of patients with Serious Adverse Events

  Up to 87 Days

• Change from baseline in BILAG

  Up to 87 Days

• Change from baseline in SLEDAI-2K

  Up to 87 Days

Study Arms (2)

Group A

EXPERIMENTAL

4 weeks place followed by 4 weeks IMP

Drug: BI 705564; Drug: Placebo

Group B

EXPERIMENTAL

4 weeks IMP followed by 4 weeks placebo

Drug: BI 705564; Drug: Placebo

Interventions

BI 705564 DRUG

Film-coated Tablet

Group A; Group B

Placebo DRUG

Film-coated Tablet

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• ≥ 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.
• 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
• The patient must follow true abstinence from male-female sex. This is defined as being in line with the preferred and usual lifestyle of the patient. Periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods; declaration of abstinence for the duration of exposure to IMP; and withdrawal are not acceptable.
• A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

You may not qualify if:

• 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.
• Initiation of regular nonsteroidal anti-inflammatory drugs (NSAIDs) use within 2 weeks prior to Screening. Regular use defined as 3 consecutive days.
• Within 2 months prior to Screening or during Screening: initiation of or change in dose of methotrexate, mycophenolate (mofetil or sodium), or azathioprine.
• Within 4 weeks prior to Screening or during Screening, use of cyclosporine or tacrolimus.
• Within 3 months prior to Screening or during Screening: use of cyclophosphamide or chlorambucil.
• Within 3 months prior to Screening or during Screening, use of leflunomide, abatacept, anti-tumor necrosis factor alpha agents, intravenous immunoglobulin, plasmapheresis, or other disease modifying, immunosuppressive, or immunomodulatory therapies not otherwise specified in protocol.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 11, 2018
• Study Start: March 16, 2019
• Primary Completion: December 21, 2019
• Study Completion: January 7, 2020
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share