A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,400
- 试验地点
- 279
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with the signs and symptoms of moderate to severe HS .
Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms.
In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks.
Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will continue to receive lutikizumab SC using the same assigned dosing regimen from the end of Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks.
Participants in the US that complete Periods 1 & 2 will have the option to enroll in a 156-week open-label Sub-Study that will assess the long term safety and efficacy of lutikizumab in a prefilled pen.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant).
- •Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline
- •Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic areas at Baseline.
- •At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
排除标准
- •Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •Confirmed positive anti-HIV antibody (HIV Ab) test.
- •Evidence of active tuberculosis or meets tuberculosis exclusionary parameter
研究组 & 干预措施
Period 2: Lutikizumab Every Other Week
Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A every other week though week 52
干预措施: Lutikizumab (Drug)
Period 3: Open-label Lutikizumab
Starting at Week 68 in Period 3, all participants will receive Open-label Lutikizumab every other week
干预措施: Lutikizumab (Drug)
Sub-Study: Lutikizumab Pre-Filled Pen
Lutikizumab solution for injection in prefilled pen (EOW) for 60 weeks, followed by lutikizumab solution for injection in prefilled syringes (EOW) for 96 weeks.
干预措施: Lutikizumab (Drug)
Period 1
Participants will be randomized to either Lutikizumab Dose B at baseline followed by Lutikizumab Dose A, or a matching placebo dose equivalent for both, every week through Week 16 .
干预措施: Lutikizumab (Drug)
Period 2: Lutikizumab Every Week
Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A through Week 52
干预措施: Lutikizumab (Drug)
Period 2: Placebo to Lutikizumab Group Every Other Week
The participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every other week through Week 52
干预措施: Lutikizumab (Drug)
Period 2: Lutikizumab Every Other Week
Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A every other week though week 52
干预措施: Placebo (Drug)
Period 1
Participants will be randomized to either Lutikizumab Dose B at baseline followed by Lutikizumab Dose A, or a matching placebo dose equivalent for both, every week through Week 16 .
干预措施: Placebo (Drug)
Period 2: Placebo to Lutikizumab Group
Participants randomized to Placebo in Period 1 who complete Week 16 of the study will initiate lutikizumab with Dose B followed by Dose A every week.
干预措施: Lutikizumab (Drug)
Period 2: Placebo to Lutikizumab Group Every Week
Participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every week through Week 52
干预措施: Lutikizumab (Drug)
Period 2: Placebo to Lutikizumab Group Every Other Week
The participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every other week through Week 52
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to Approximately Week 62
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
时间窗: At Week 16
HiSCR 75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess count and no increase in draining fistula count relative to baseline.
次要结局
- Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3(At Week 8)
- Change from Baseline in Dermatology Life Quality Index (DLQI) among participants ≥ 16 years of age at Baseline(At Week 16)
- Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)(At Week 16)
- Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) Worst Drainage Score(At Week 16)
- Change from Baseline in number of Draining Fistulas Count among participants with at least 1 draining fistula at Baseline(At Week 16)
- Percentage of Participants Achieving HiSCR 90(At Week 16)
- Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS)(At Week 8)
- Change from Baseline in HSSA(At Week 16)
- Change from Baseline in the Patient's Global Assessment of HS-related Odor (smell), based on the HSSA Question 8(At Week 16)
- Percentage of Participants with an Occurrence of HS Flare in Period 1(Baseline to Week 16)
- Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) Emotional Domain(At Week 16)
- Change from Baseline in HSIA Mobility Domain(at Week 16)