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A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.
Phase 3 trial testing Benralizumab in Bullous Pemphigoid in 67 participants. Terminated before completion.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 67 |
| Start date | 31 March 2021 |
| Primary completion | 26 October 2023 |
| Estimated completion | 26 October 2023 |
| Sites | 39 locations across France, Italy, Japan, Greece, Germany, Israel, Bulgaria, Australia |
AstraZeneca — full company profile →
Adults 18 to 130, any sex, with Bullous Pemphigoid. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A responder was defined as a participant who was in complete remission while off OCS for ≥2 months at Week 36.
| Group | Value | 95% CI |
|---|---|---|
| DB Period: Benralizumab | 11.1 | -2.70 – 26.11 |
| DB Period: Placebo | 5.26 | -5.06 – 15.07 |
Relapse was defined as the appearance of 3 or more new lesions per month (blisters, eczematous lesions, or urticarial plaques); or at least 1 large (\>10 centimeter \[cm\] diameter) eczematous lesion or urticarial plaques that did not heal within 1 week; or the extension of established lesions or daily pruritus in participants who had achieved disease control.
| Group | Value | 95% CI |
|---|---|---|
| DB Period: Benralizumab | 23.78 | 5.95 – 41.61 |
| DB Period: Placebo | 19.79 | 1.43 – 38.15 |
The cumulative OCS exposure was estimated as the sum over the relevant 4-week periods from the mixed-effect model for repeated measures (MMRM) model. Baseline was defined as the last recorded value on or prior to the date of randomization. Equivalents were prednisone equivalents (converted from mg).
| Group | Value | 95% CI |
|---|---|---|
| DB Period: Benralizumab | 71.37 | ± 63.19 |
| DB Period: Placebo | 62.71 | ± 46.90 |
BPDAI is a clinician completed tool that is used for independent disease severity assessment to measure disease extent in BP. The total BPDAI activity score is calculated as the arithmetic sum of the 3 subcomponents - cutaneous blisters/erosions, cutaneous urticaria/erythema, and mucosal blisters/erosions. The BPDAI total activity gives an indication of disease activity, with score range from 0 (no disease activity) to 360 (severe disease activity). Higher scores indicating greater disease activity. Baseline was defined as the last recorded value on or prior to the date of randomization.
| Group | Value | 95% CI |
|---|---|---|
| DB Period: Benralizumab | -53.29 | ± 46.33 |
| DB Period: Placebo | -52.75 | ± 17.36 |
The BPDAI-Pruritus is a separate component of the BPDAI that asks the participant to grade the severity of pruritus over the past 24 hours, the past week, and the past month. For each recall period, severity of pruritus is rated on a numeric rating scale (NRS) ranging from 0 for no itch to 10 for maximal itching. The BPDAI-Pruritus score was computed as the sum of 3 components ranging from 0 to 30. Higher scores indicated worse condition. Baseline was defined as the last recorded value on or prior to the date of randomization.
| Group | Value | 95% CI |
|---|---|---|
| DB Period: Benralizumab | -5.57 | ± 7.23 |
| DB Period: Placebo | -16.58 | ± 9.21 |
The cumulative OCS exposure was estimated as the sum over the relevant 4-week periods from the MMRM model. Baseline was defined as the last recorded value on or prior to the date of randomization. Equivalents were prednisone equivalents (converted from mg).
| Group | Value | 95% CI |
|---|---|---|
| DB Period: Benralizumab | 46.90 | ± 27.19 |
| DB Period: Placebo | 42.15 | ± 33.33 |
Time frame: All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected from first dose of study treatment (Day 1) up to study termination (approximately 133 weeks).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | DB Period: Benralizumab | DB Period: Placebo | OLE Period: Benralizumab (… | OLE Period: Placebo (DB)/B… |
|---|---|---|---|---|---|
| Pemphigoid | Skin and subcutaneous tissue disorders | — | — | — | — |
| Covid-19 | Infections and infestations | — | — | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Bacterial infection | Infections and infestations | — | — | — | — |
| Covid-19 pneumonia | Infections and infestations | — | — | — | — |
| Cellulitis | Infections and infestations | — | — | — | — |
| Pneumocystis jirovecii pneumonia | Infections and infestations | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Pneumonia aspiration | Infections and infestations | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — |
| Staphylococcal sepsis | Infections and infestations | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Cardiac failure acute | Cardiac disorders | — | — | — | — |
| Spinal fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Wound dehiscence | Injury, poisoning and procedural complications | — | — | — | — |
| Diabetes mellitus | Metabolism and nutrition disorders | — | — | — | — |
| Gout | Metabolism and nutrition disorders | — | — | — | — |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Henoch-schonlein purpura | Skin and subcutaneous tissue disorders | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — |
| Reaction | System | DB Period: Benralizumab | DB Period: Placebo | OLE Period: Benralizumab (… | OLE Period: Placebo (DB)/B… |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — |
| Herpes zoster | Infections and infestations | — | — | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Oral candidiasis | Infections and infestations | — | — | — | — |
| Tinea pedis | Infections and infestations | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — |
| Weight increased | Investigations | — | — | — | — |
| Hypoglycaemia | Metabolism and nutrition disorders | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — | — |
| Haematuria | Renal and urinary disorders | — | — | — | — |
| Renal impairment | Renal and urinary disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Dermatitis contact | Skin and subcutaneous tissue disorders | — | — | — | — |
| Skin ulcer | Skin and subcutaneous tissue disorders | — | — | — | — |
| Urticaria | Skin and subcutaneous tissue disorders | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Gastrointestinal disorder | Gastrointestinal disorders | — | — | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — | — | — |
| Hiatus hernia | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Hepatic function abnormal | Hepatobiliary disorders | — | — | — | — |
| Body tinea | Infections and infestations | — | — | — | — |
| Bronchitis | Infections and infestations | — | — | — | — |
| Coronavirus infection | Infections and infestations | — | — | — | — |
| Onychomycosis | Infections and infestations | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
| Arthropod bite | Injury, poisoning and procedural complications | — | — | — | — |
| Fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — | — | — |
| Heart rate increased | Investigations | — | — | — | — |
Most-reported serious reactions: Pemphigoid, Covid-19, Osteoarthritis, Bacterial infection, Covid-19 pneumonia, Cellulitis, Pneumocystis jirovecii pneumonia, Pneumonia.
Data from ClinicalTrials.gov NCT04612790 adverse events section.
The purpose of this study is to investigate the use of benralizumab is effective in the treatment of patients symptomatic Bullous Pemphigoid (BP).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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