Efficacy of BELImumab for therapy-resistant SKIN manifestations in patients with lupus erythematosus (LE): A phase III, multicenter, randomized, double-blind, placebo-controlled, 24-week trial (BELI-SKIN)

Phase 1

• Conditions: Patients with lupus erythematosus (LE) with active, therapy-resistant skin manifestations receiving Standard of Care (SOC) therapy; MedDRA version: 20.0Level: HLTClassification code 10025135Term: Lupus erythematosus (incl subtypes)System Organ Class: 100000004859; MedDRA version: 21.1Level: LLTClassification code 10025134Term: Lupus erythematosusSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2017-003051-35-DE
• Lead Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-30
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. At least 18 years of age
2. Patients with a clinically and histologically confirmed diagnosis of LE-specific skin lesions
3. Patients with active skin manifestations at time of enrolment
4. Patients who meet at least two of the American College of Rheumatology (ACR) criteria for LE (= 2 criteria) (Patients with cutaneous forms of LE
without systemic involvement who meet all inclusion criteria may be in-cluded)
5. Patients with positive ANA (titre = 1:80, at least once within the last 3 years (no longer applicable after amendment 3)
6. Total RCLASI skin activity score of = 6
7. Patients receiving stable standard therapy for at least 30 days prior to day 0; corticosteroids may have been added as new medication or dose ad-justed up to 30 days prior to day 0; new LE therapy, other than cortico-steroids, were not added within 60 days prior to day 0; permitted medica-tions for stable standard therapy alone or in combination included:
o Systemic prednisone or its equivalent up to 40 mg/day and/or class I, II, or III; topical corticosteroids up to 2 times a day (lesional applica-tion only)
o antimalarials including hydroxychloroquine, chloroquine or quinacrine
o non-steroidal anti-inflammatory agents (NSAID)
o immunosuppressive or immunomodulatory agents including metho-trexate, azathioprine, dapsone, leflunomide, mycophenolate (includ-ing mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (e.g., tacrolimus, cyclo-sporine), sirolimus, 6-mercaptopurine or thalidomide and/or topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) up to 2 times a day (lesional application only)
o Please note: Topical corticosteroids (class I, II, or III up to 2 times a day with lesional application only) or topical calcineurin inhibitors (such as tacrolimus or pimecrolimus, up to 2 times a day with lesional appli-cation only) as the only Standard of Care medication is exclusively permitted in localized CLE disease (in accordance with the EADV s2k guideline4). For severe and widespread skin manifestations, a purely topical therapy is not sufficient as SOC.
8. Subjects with the ability to follow study instructions and likely to attend and complete all required visits
9. Written informed consent of the subject
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 65
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

? Subj not able to give consent ? Subj without legal capacity who is unable to understand the nature,scope, significance a consequences of this clinical trial ? Known history of hypersens to the IMP or to drugs with a similar chem structure ? Simultaneous particip in another interventional CT or particip in any CT involving admin of an IMP/biological agent within 60 d prior to CT beginning ? Subj with a physical or psychiatric condition which at investig's discretion may put the subj at risk, may confound the trial results, or may interfere with the subj's particip in this CT ? Known or persistent abuse of medication, drugs or alcohol within 365 d prior to d 0 ? Current or planned pregnancy or nursing women ? Females of childbearing potential, who are not using and not willing to use medically reliable methods of contracep for the entire study duration unless they are surgically sterilized/ hysterectomized or there are any other criteria considered sufficiently reliable by the investig in individual cases ? Pat with a
history of malignant neoplasm within the last 5 y with the exception of basal cell or squamous cell carcinoma of skin treated with local resection only or carcinoma in situ of uterine cervix treated locally and with no evidence of metastatic disease for 3 y ? Pat with evidence of serious
suicide risk incl any history of suicidal behavior in the last 6 mo and/or any suicidal ideation = 4 on the CSSRS ideation scale in the last 2 mo or
who in the investig's judgment pose a significant suicide risk ? Pat who have required high-dose prednisone (>100 mg/day) or its equivalent
within 90 d prior to d 0 ? Severe lupus kidney disease (proturia >6 g/24 h or equivalent using spot urine protein to creatinine ratio, or serum
creatinine >2.5 mg/dL), active nephritis or have required hemodialysis or high-dose prednisone (>100 mg/day) within 90 d prior to d 0 ?
Active central nervous system lupus, incl seizures, psychosis, organic brain syndrome,cerebrovascular accident, cerebritis or CNS vasculitis,
that required therapeutic intervention within 60 days prior to day 0 ? History of a major organ transpl or hematopoietic stem cell/marrow
transplant ? Previous treat with intravenous IG up to 3 mo fore enrolment ? Previous treat with belimumab or any investigational
biologic agent within 1 year before enrolment or an investigational non biologic agent within 60 days or 5 pharmacokinetic half-lives (whichever
is longer) prior to enrol ? Treatm with immunomodulating drugs for other reasons than LE within 60 d prior to d 0 ? Active skin disease
other than LE-specific or LE-non-specific manifesta ? Pat previously hypersensitive to B-lymphocyte-targeted drug (incl rituximab) or
Belimumab ? Currently on any suppressive therapy for a chronic infection (eg tuberculosis,pneumocystis, cytomegalovirus,..) ? Hospitaliz for treatm of infection within 60 d prior to Day 0. ? Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, antifungals or anti-parasitic agents) within 60 days prior to Day 0 ? Pat with a historically pos HIV test or test pos at screening for HIV ? Serologic evidence of current or past HepB infection based on positive testing for HBsAg or HBcAb. ? Positive test for HepC antibody ? Pat with a history of a prim immunodeficiency ? Pat with a significant IgG deficiency (IgG level < 400 mg/dL) ? Pat with an IgA deficiency (IgA level < 10 mg/dL) ? Have a history of an anaphyl reaction to parenteral admin of contrast agents, hum

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified