Phase II Long-term Extension Study to Assess the Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 165
- 试验地点
- 29
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate to severe chronic plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Woman Of Child Bearing Potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly from date of screening until 4 weeks after last treatment in this trial. A list of contraception methods meeting these criteria is provided in the patient information.
- •Patients with moderate-to-severe plaque Psoriasis (PsO) who have completed treatment in the preceding trial without early discontinuation, agree to continue treatment in 1407-0005, and
- •for patients entering from Part 1 of trial 1407-0030
- •-- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 24 end-of-treatment visit
- •for patients entering from Part 2 of trial 1407-0030 --- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 12 end-of-treatment visit or perceived patient improvement, at the discretion of the Investigator
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
排除标准
- •Nonplaque forms of PsO (including guttate, erythrodermic, or pustular), current druginduced PsO (including a new onset or exacerbation of PsO from, e.g., beta blockers, calcium channel blockers, lithium), active ongoing inflammatory diseases (including but not limited to inflammatory bowel disease (IBD)) other than PsO that might confound trial evaluations.
- •Previous enrolment in this trial.
- •Currently enrolled in another investigational device or drug trial or is receiving other investigational treatment(s) (with the exception of 1407-0030).
- •Intake of any restricted medication or any drug considered likely to interfere with the safe conduct of the trial.
- •Any plan to receive a live vaccination during the conduct of the trial.
- •Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled.
- •Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.
- •Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- •Any documented active or suspected malignancy, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.
- •Relevant chronic or acute infections including human immunodeficiency virus (HIV), viral hepatitis and tuberculosis.
- •Evidence of a disease (including known or suspected IBD, cardiovascular disease), or medical finding that in the opinion of the Investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
- •Any suicidal ideation, including grade 4 or 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) in the past 12 months (i.e., active suicidal thought with intent but without specific plan), or active suicidal thought with plan and intent in the past.
- •Unwillingness to adhere to the rules of UV-light protection
- •Ongoing AEs consistent with intolerance of trial medication (including gastric intolerance) from 1407-0030, that in the opinion of the investigator would compromise the safety of the patient.
研究组 & 干预措施
100 mg BI 730357
100 mg BI 730357 + placebo under fasted conditions.
干预措施: BI 730357 (Drug)
25 mg BI 730357
25 mg BI 730357 + placebo under fasted conditions.
干预措施: BI 730357 (Drug)
25 mg BI 730357
25 mg BI 730357 + placebo under fasted conditions.
干预措施: Placebo to match BI 730357 (Drug)
50 mg BI 730357
50 mg BI 730357 + placebo under fasted conditions.
干预措施: BI 730357 (Drug)
50 mg BI 730357
50 mg BI 730357 + placebo under fasted conditions.
干预措施: Placebo to match BI 730357 (Drug)
100 mg BI 730357
100 mg BI 730357 + placebo under fasted conditions.
干预措施: Placebo to match BI 730357 (Drug)
200 mg BI 730357
200 mg BI 730357 + placebo under fasted conditions
干预措施: BI 730357 (Drug)
200 mg BI 730357
200 mg BI 730357 + placebo under fasted conditions
干预措施: Placebo to match BI 730357 (Drug)
400 mg BI 730357
400 mg BI 730357 + placebo under fasted conditions.
干预措施: BI 730357 (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days.
Number of participants with treatment emergent adverse events (TEAEs). For dose groups 25 mg - 200 mg BI, TEAEs are reported separately for period 1 and period 2. Period 1: All patients who started in period 1 are reported by starting dose (25, 50, 100 and 200 mg). Period 2: Only patients who participated in period 2 are reported by dose sequence group. For dose group 400 mg BI, TEAEs are reported overall (period 1 + period 2). Number of participants with TEAEs is reported.
次要结局
- Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24(At week 24.)
- Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24(At week 24.)
- Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24(At baseline and at week 24.)
- Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response(Up to 802 days.)
- Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response(Up to 802 days.)
- Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response(Up to 802 days.)