BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)

• Register: ClinicalTrials.gov
• Last refreshed on: 22 November 2021
• Main ID: NCT03771885
• Date of registration: 10/12/2018
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)
• Scientific title: 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.
• Date of first enrolment: March 16, 2019
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03771885
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Key inclusion & exclusion criteria

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

- 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

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.

- Patients with APS antibodies may be included unless they are excluded due to
exclusion anti-coagulation medication (see exclusion criteria below for details)
or if they have a history of thromboembolic events or miscarriage.

- 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.

- Within 12 months prior to screening or during screening: use of anti-CD20 or anti-CD22
biological medications or any other B cell-depleting medication. If a patient has had
rituximab more than 6 months ago and has a normal CD-19 count then they may be
included. A historic local lab value may be used to confirm this. For B-cell
modulating therapies including atacicept t


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Drug: Placebo

Drug: BI 705564

Primary Outcome(s)

The primary endpoint to assess safety and tolerability of BI 705564 is the number of patients with drug related Adverse Events [Time Frame: Up to 73 Days]

Secondary Outcome(s)

Change from baseline in SLEDAI-2K [Time Frame: Up to 87 Days]

Change from baseline in BILAG [Time Frame: Up to 87 Days]

Number of patients with Adverse Events [Time Frame: Up to 87 Days]

Number and severity of Adverse Events [Time Frame: Up to 87 Days]

Number of patients with Serious Adverse Events [Time Frame: Up to 87 Days]

Secondary ID(s)

1408-0004

2017-004948-38

Source(s) of Monetary Support

Please refer to primary and secondary sponsors