Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03427151
• Date of registration: 08/12/2017
• Prospective Registration: Yes
• Primary sponsor: ImmuPharma
• Public title: Study of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus IP-006
• Scientific title: An Open-label Study of the Safety and Tolerability of Repeated Administration of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
• Date of first enrolment: February 27, 2018
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03427151
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Czechia, France, Germany, Hungary, Mauritius, Poland, Puerto Rico, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient had participated previously to study IP-005

- Written informed consent is obtained.

- Female and males receiving IPP-201101 and their female partners must use a highly
effective contraceptive during treatment and for 30 days after discontinuation of
study drug treatment.

- Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing
potential, use a highly effective method of contraception, Men and their partner must
have highly effective accepted method of contraception. Single barrier/Double barrier
and spermicides are not acceptable methods of contraception. Highly effective methods
of contraception include, true abstinence, intrauterine device (IUD), or hormonal
contraception associated with inhibition of ovulation (oral, transdermal, implanted,
and injected), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion,
vasectomised partner. True abstinence is defined when this is in line with the
preferred and usual lifestyle of the subject." [Periodic abstinence (e.g., calendar,
ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the
duration of a trial, and withdrawal are not acceptable methods of contraception]

- If the patient is using oral corticosteroids, the weekly cumulative dose must not
exceed 80 mg of prednisone equivalent; the weekly dose must be stable over the 4 weeks
preceding the 1st dose of study drug.

- If the patient is using antimalarials, methotrexate, leflunomide, mycophenolate
mofetil (MMF), or azathioprine, the start date must be at least 3 months prior to the
1st dose of study drug, and the daily dose must be stable over the 4 weeks preceding
the 1st dose of study drug.

- If the patient is not currently using corticosteroids, antimalarials, methotrexate,
MMF, or azathioprine, the last dose (in case of previous use) must be at least 4 weeks
prior to the 1st dose of study drug. For leflunomide, the stop date must be at least 8
weeks before the 1st dose of study drug unless an adequate cholestryamine washout has
been performed. If cholestyramine washout is performed, the last use of leflunomide
must be at least 4 weeks before the 1st dose of study drug.

- The patient must be willing and able to comply with study restrictions, to remain at
the study center for the required duration during each study visit, and to return to
the study center for the final assessment as specified in this protocol.

Criteria for Exclusion: Patients are excluded from participating in this study if 1 or more
of the following criteria are met:

- The patient has been treated with intramuscular or intravenous (iv) pulse steroids
(ie, 250 to 1000 mg iv total daily dose of methylprednisolone) within 4 weeks of the
1st dose of study drug. The use of intra-articular steroids may be allowed after
consultation with the medical expert.

- The patient has received tacrolimus, cyclosporin A, or iv immunoglobulins (IVIG)
within 3 months of the 1st dose of study drug.

- The patient has received cyclophosphamide within 6 months prior to the 1st dose of
study drug.

- The patient has been treated for SLE with agents such as fusion proteins, therapeutic
proteins, or monoclonal antibodies or antibody fragments, within 6 months of the 1st
dose of study drug.

- The patient has received B-cell depleting agents such as rituximab or belimumab or
epratuzumab within one year of the 1st dose and has not yet normalized the B-cell
count (ie, CD20+ B-cell count is less than normal range and the absolute lymphocyte
count [ALC] is less than normal range).

- The patient has New York Heart Association (NYHA) Class III or IV congestive heart
failure.

- The patient has an estimated glomerular filtration rate (eGFR) of less than 30
mL/min/1.73 m2 (via Modification of Diet in Renal Disease [MDRD] equation).

- The patient has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
value greater than 2 times the upper limit of the normal range (ULN) or a total
bilirubin level greater than 1.5 times ULN.

- The patient has a planned immunization with a live or live attenuated vaccine within 3
months prior to administration of the 1st dose of study drug and for 3 months after
administration of the last dose of study drug.

- The patient has any clinically significant abnormalities on ECG that are not related
to SLE, as determined by the investigator. Patients with stable ECG changes without
evidence of active cardiovascular disease may participate at the discretion of the
investigator and medical monitor.

- The patient has an ongoing active systemic infection requiring treatment or a history
of severe infection, such as hepatitis or pneumonia, in the 3 months prior to
administration of the 1st dose of study drug. Less severe infections in the 3 months
prior to administration of the 1st dose of study drug are permitted at the discretion
of the investigator and medical monitor.

- The patient has any concomitant medical condition unrelated to SLE that may interfere
with his or her safety or with evaluation of the study drug, as determined by the
investigator.

- The patient has a history of a medical condition other than SLE that has required
treatment with oral corticosteroids in excess of 80 mg of prednisone equivalent/week
within 3 months of the 1st dose of study drug.

- The patient has a positive test result for hepatitis B surface antigen (HBsAg) or
hepatitis C virus antibody (HCV Ab).

- The patient has a known positive history of antibodies to human immunodeficiency virus
(HIV) or HIV disease or other immunosuppressive state (eg, agammaglobulinemia, etc).

- The patient has a history of alcohol or substance dependence or abuse (with the
exception of nicotine),according to the Diagnostic and Statistical Manual of Mental
Disorders of the American Psychiatric Association, Fourth Edition, Text Revision
(DSM-IV-TR), within 3 months of the screening visit or has current substance abuse.

- The patient has a history of severe allergic reactions to or hypersensitivity to any
component of the study drug.

- The patient has undergone or is undergoing treatment with another investigational drug
for the treatment of lupus within 6 months prior to the 1st dose of study drug or has
received any other investigational drug for any other condition within 4 weeks prior
to the 1st dose of study drug except for IPP-201101

- The patient is


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

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Drug: IPP-201101

Primary Outcome(s)

Clinical laboratory test results at each visit during the treatment extension period [Time Frame: 7 months]

Physical examination findings, at specified time points at each visit during the treatment extension period [Time Frame: 7 months]

Systolic and diastolic blood pressures measurements at each visit during the treatment period [Time Frame: 7 months]

Concomitant medication usage throughout the study extension [Time Frame: 7 months]

Occurrence of adverse events throughout the study [Time Frame: 7 months]

Pulse measurements at each visit during the treatment period [Time Frame: 7 months]

Temperature measurements at each visit during the treatment period [Time Frame: 7 months]

2-lead electrocardiogram (ECG) findings at week 28 (or final assessment) [Time Frame: 7 months]

Body weight measurements at each visit during the treatment period [Time Frame: 7 months]

Secondary Outcome(s)

remission of the disease (i.e reduction of clinical SLEDAI-2K score to 0) [Time Frame: at week 28]

the effect in the Clinical SLEDAI-2K total score by at final visit compared to initial visit [Time Frame: at week 28]

Secondary ID(s)

IPP-201101/006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors