2024-510745-34-00已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients with Bullous Pemphigoid
Regeneron Pharmaceuticals Inc.23 个研究点 分布在 4 个国家目标入组 57 人开始时间: 2024年8月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 23
- 主要终点
- Proportion of patients achieving sustained remission.
研究概览
简要总结
The primary objective of the study is to demonstrate that dupilumab is superior to placebo in achieving sustained remission off OCS in patients with Bullous Pemphigoid (BP).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 to 90 at the screening visit.
- •Patients must have characteristic clinical features of bullous pemphigoid (BP) (eg, urticarial or eczematous or erythematous plaques, bullae, pruritus) at the screening and baseline visits.
- •Study participants are required to have a confirmed diagnosis of BP based on histopathology, immunopathology, and serology at the baseline visit, as defined in the protocol.
- •Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥24 at baseline and screening visits.
- •Baseline peak pruritus NRS score for maximum itch intensity ≥
- •Karnofsky performance status score ≥50% at the screening visit.
- •Note: Other Protocol Defined Inclusion Criteria Apply
排除标准
- •Forms of pemphigoid other than classic BP (eg, Brunsting-Perry cicatricial pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita, or BP with concomitant pemphigus vulgaris).
- •Patients who are receiving treatments known to cause or exacerbate BP (eg, angiotensin converting enzyme inhibitors, penicillamine, furosemide, phenacetin, dipeptidyl peptidase 4 inhibitor) who have not been on a stable dose of these medications for at least 4 weeks prior to the screening visit.
- •Have ever received treatment with an IL-4 or IL-13 antagonist such as dupilumab, tralokinumab, or lebrikizumab.
- •Treatment with systemic corticosteroids within 7 days before the baseline visit.
- •Treatment with topical corticosteroids of medium potency or higher, topical calcineurin inhibitor, or topical crisaborole within 7 days before the baseline visit.
- •Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit.
- •Treatment with BP-directed biologics as follows: (a) Any cell-depleting agents including but not limited to rituximab: within 12 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer, (b) Other biologics (such as IL-5 inhibitors benralizumab or mepolizumab): within 5 half-lives (if known) or 16 weeks prior to the baseline visit, whichever is longer, and (c) Intravenous immunoglobulin within 16 weeks prior to the baseline visit.
- •Note: Other Protocol Defined Exclusion Criteria Apply
结局指标
主要结局
Proportion of patients achieving sustained remission.
Proportion of patients achieving sustained remission.
次要结局
- Total cumulative dose of oral corticosteroids (OCS).
- Percent change in weekly average of daily peak pruritus numerical rating score (NRS).
- Proportion of patients with improvement (reduction) of weekly average of daily peak pruritus NRS ≥4.
- Percent change in Bullous Pemphigoid Disease Area Index Activity Score (BPDAI) activity score.
- Time to first use of rescue medication.
- Duration of complete remission while not requiring OCS.
- Proportion of patients who do not achieve control of disease activity, who relapse after achieving control of disease activity, or do not achieve complete remission.
- Proportion of patients who achieve a reduction in BPDAI activity score of at least 50%, 75%, and 90%.
- Change in autoimmune bullous disease quality of life (ABQOL).
- Change in percent body surface area (BSA) of BP involvement.
- Change in BP180 autoantibody (IgG) titers.
- Change in BP230 autoantibody (IgG) titers.
- Proportion of patients with sustained remission.
- Total cumulative dose of OCS.
- Percent change in weekly average of daily peak pruritus NRS.
- Percent change in BPDAI activity score.
- Change in ABQOL.
- Change in percent BSA of BP involvement.
- Proportion of patients in complete remission and off OCS.
- Incidence of treatment-emergent adverse events (TEAEs).
- Incidence of treatment-emergent serious adverse events (SAEs).
- Incidence of adverse events of special interest (AESIs).
- Concentrations of functional dupilumab in serum.
- Incidence of treatment-emergent anti-drug antibody (ADA) responses and titer.
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (23)
Loading locations...
相似试验
招募中
4 期
A phase IV, randomized double blinded placebo-controlled study on the barrier restoring capacity of Dupilumab in type 2 airway disease: CRSwNP2023-504014-30-00UZ Leuven44
招募中
3 期
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC 8)2023-506891-28-00Astrazeneca AB280
招募中
4 期
DUPI REDUCE trial (DUPIlumab dose REDUCtion in patients with controlled atopic Eczema): a multicenter, low-intervention, non-inferiority randomized controlled trial, embedded in the TREAT NL registry.2023-504171-24-00Amsterdam UMC216
招募中
3 期
A Global Study to Assess the Effects of Durvalumab with Oleclumab or Durvalumab with Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC-9)2023-503999-24-00AstraZeneca AB437
尚未招募
3 期
A Phase III Study to Evaluate the Efficacy and Safety of MDR-001 in Adult Participants With Overweight or Obesity (MOBILE）NCT07274137MindRank AI Ltd738