A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid. (NCT04612790) | Clinical Trial Compass
TerminatedPhase 3
A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.
Stopped: Independent Data Monitoring Committee recommended terminating the study following a pre-planned analysis as the efficacy results did not meet the pre-defined futility guidelines. There were no new safety concerns identified from this analysis.
United States67 participantsStarted 2021-03-31
Plain-language summary
The purpose of this study is to investigate the use of benralizumab is effective in the treatment of patients symptomatic Bullous Pemphigoid (BP).
Who can participate
Age range18 Years – 130 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
✓. Adult participants ≥ 18 years of age at the time of signing the ICF.
✓. Participants must have clinical features of BP (eg, urticarial or eczematous or erythematous plaques, bullae, pruritus) at the screening visit and confirmed diagnosis with histology, direct immunofluorescence, and serology at randomization. Required for inclusion:
✓. Histology.
✓. Positive direct immunofluorescence (from skin biopsy) (IgG and/or C3 at the basement membrane zone).
✓. AND at least one of the following serologic assessments positive (all assessed from participant's blood sample):
✓. BPDAI activity score ≥ 24 at the screening and randomization visits.
✓. Candidate for systemic corticosteroid therapy.
Exclusion criteria
✕. Forms of BP other than classic, predominantly cutaneous BP: eg, mucous membrane BP, epidermolysis bullosa acquisita, Brunsting-Perry BP, p200 BP, p105 BP, BP with concomitant pemphigus vulgaris, and drug-induced BP.
✕. Comorbid disease that in the Investigator's judgement might interfere with the evaluation of the IP or safety of the participant. This includes any disorder that in the opinion of the Investigator is not stable (eg, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment).
✕. Current or history of malignancy within 5 years before the screening visit with the following exceptions:
✕. Participants treated for in situ carcinoma of the cervix who have completed curative therapy and are in remission for at least 12 months prior to signing the informed consent and
✕. Participants with superficial basal cell or squamous skin cancer.
✕. Participants who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained.
✕. History of anaphylaxis to any biologic therapy or vaccine.
✕. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.