An open-label study to evaluate the safety and tolerability of 200-mcg Dose of IPP-201101 in Patients With SLE

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2017-004060-35-HU
• Date of registration: 10/01/2018
• Prospective Registration: Yes
• Primary sponsor: ImmuPharma
• Public title: An open-label study to evaluate the safety and tolerability of 200-mcg Dose of IPP-201101 in Patients With SLE
• 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: 12/03/2018
• Target sample size: 75
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004060-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Hungary, Mauritius, United States

Contacts

• Name: FANNY VALLEIX
• Affiliation: ImmuPharma

• Name: FANNY VALLEIX
• Affiliation: ImmuPharma

Key inclusion & exclusion criteria

Inclusion criteria:
a) Patient had participated previously to study IP-005
b) Written informed consent is obtained
c) 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]
d) 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.
e) 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.
f) 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.
g) 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion criteria:
(a) 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.
(b) The patient has received tacrolimus, cyclosporin A, or iv immunoglobulins (IVIG) within 3 months of the 1st dose of study drug.
(c) The patient has received cyclophosphamide within 6 months prior to the 1st dose of study drug.
(d) 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.
(e) The patient has received B-cell depleting agents such as rituximab, belimumab or epratuzumab within one year of the 1st dose of study drug 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).
(f) The patient has New York Heart Association (NYHA) Class III or IV congestive heart failure.
(g) 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).
(h) 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.
(i) 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.
(j) 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.
(k) 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.
(l) 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.
(m) 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.
(n) The patient has a positive test result for HBsAg or HCV Ab.
(o) The patient has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease or other immunosuppressive state (eg, agammaglobulinemia, etc).
(p) 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 Associati

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus
MedDRA version: 20.0 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Body processes [G] - Immune system processes [G12]

Intervention(s)

Product Name: IPP-201101
Product Code: IPP-201101
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: IPP-201101
Current Sponsor code: IPP-201101
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Secondary Objective: The secondary efficacy objectives of the study extension are to evaluate the following:
• the effect of IPP-201101 in the Clinical SLEDAI-2K total score at final visit compared to initial visit.
• remission of the disease (ie: reduction of clinical SLEDAI 2K score to 0)

Timepoint(s) of evaluation of this end point: weeks 4, 8,12,16,20,24 and 28 (or final assessment)

Main Objective: The primary objective of this study is to evaluate the safety and tolerability of a 200-mcg dose every 4 weeks for 24 weeks of IPP-201101 in patients with systemic lupus erythematosus (SLE) who had participated in the main study IP-005.

Primary end point(s): Safety measures and endpoints will include the following:
• Occurrence of adverse event throughout the study
• Clinical laboratory test (serum chemistry, hematology, and urinalysis) t each visit during the treatment period
• Vital signs (systolic and diastolic blood pressure, pulse temperature and body weight) measurements at each visit during the treatment period
• 12-lead electrocardiography (ECG) at the final assessment (or early termination) and at baseline for patients who have already terminated the main study.
• Physical examination findings, including physical examination symptom directed findings, at selected time points throughout the study
• Concomitant medication usage throughout the study.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: week 28 or (final assessment)

Secondary end point(s): Secondary Measures/variables and Endpoint: The efficacy variables and endpoints for the extension study are to determine the following:
• the effect of IPP-201101 in the Clinical SLEDAI-2K total score at final visit compared to initial visit.
• remission of the disease (ie: reduction of clinical SLEDAI 2K score to 0)

Secondary ID(s)

IPP-201101/006

Source(s) of Monetary Support

ImmuPharma

Ethics review

Status: Approved
Approval date:
Contact: