2023-507204-31-00招募中3 期
A Phase 3 Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 703
- 试验地点
- 82
- 主要终点
- Proportion of participants with treatment-emergent adverse events (TEAEs).
研究概览
简要总结
To evaluate the long-term safety of povorcitinib.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Open-Label Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Ability to comprehend and willingness to sign a written ICF for the study.
- •Completed the 54-week treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302) without safety concerns, per investigator's assessment.
- •Has demonstrated compliance, as assessed by the investigator, with the procedures described in the study Protocol of the originating parent study.
- •Agreement to use contraception, as per section 5.1.4 of the protocol.
- •Willing and able to comply with the study Protocol and procedures.
排除标准
- •Had been permanently discontinued from study treatment during the originating parent study.
- •Had any treatment-related Grade 3 or higher adverse event, or any treatment-related serious adverse event during the originating parent study that would, in the investigator's assessment, pose a significant risk to the participant's safety in this LTE study.
- •Had temporary study drug interruption at the final visit of the originating parent study and, in the opinion of the investigator, participation in this LTE study would pose an unacceptable risk to participant.
- •Any condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the Protocol.
- •Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- •Plans for administration of a live, attenuated vaccine during the course of the study or within 8 weeks after the last dose of study drug.
- •Any condition or laboratory result during the originating parent study that, in the investigator's and sponsor's (or designee's) judgment, may interfere with full participation in this LTE study, including administration of study drug and attending required study visits, may pose a significant risk to the participant, or may interfere with interpretation of study data.
- •The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code.
结局指标
主要结局
Proportion of participants with treatment-emergent adverse events (TEAEs).
Proportion of participants with treatment-emergent adverse events (TEAEs).
次要结局
- Proportion of participants with serious TEAEs.
- Proportion of participants with serious TEAEs leading to study drug discontinuation.
- Proportion of participants who achieve HiSCR at each visit. − HiSCR is defined as at least a 50% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
- Proportion of participants who achieve HiSCR75 at each visit. − HiSCR75 is defined as at least a 75% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
- Proportion of participants who achieve HiSCR90 at each visit. − HiSCR90 is defined as at least a 90% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
- Proportion of participants who achieve HiSCR100 at each visit. − HiSCR100 is defined as a 100% reduction from baseline of parent study in the total AN count, with no increase from baseline of parent study in abscess or draining tunnel count.
- Proportion of participants with flare at each visit. − Flare is defined as at least a 25% increase in AN count with a minimum increase of 2 Ans relative to Week 54.
- Time to first flare.
- Mean change from baseline of parent study in HiSQoL score at each visit. − The HiSQoL is a 17-item, HS-specific, health-related QoL instrument with a 7‐day recall period. The HiSQoL total score ranges from 0 to 68, with higher scores indicating higher disease impact on QoL.
- Mean change from baseline of parent study in DLQI at each visit. − The DLQI is a skin disease–specific questionnaire aimed at the evaluation of how the disease affects health-related QoL. The DLQI total score ranges from 0 to 30 with higher scores indicating higher skin disease impact on QoL.
- Proportion of participants with no increase in AN count relative to Week 54 at each visit.
- Proportion of participants with no increase in ANdT count relative to Week 54 at each visit. − ANdT count is defined as the total sum of abscess, inflammatory nodule, and draining tunnel.
- Proportion of participants with no increase in draining tunnel count relative to Week 54 at each visit.
- Proportion of participants with a total AN count of 0, 1, or 2 at each visit.
- Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit.
研究者
Clinical Trial Information
Scientific
Incyte Corp.
研究点 (82)
Loading locations...
相似试验
招募中
3 期
A Phase 3 Trial to Evaluate the Efficacy, Safety, and Tolerability of Zasocitinib Compared to Deucravacitinib in Participants With Moderate-to-Severe Plaque Psoriasis2024-512497-10-00Takeda Development Center Americas Inc.371
尚未招募
2 期
Golidocitinib Combined With GemOx in RR PTCLNCT07279584Ruijin Hospital31
招募中
3 期
Efficacy and Safety of Deucravacitinib Compared with Placebo in
Participants with Active Psoriatic Arthritis (PsA) who are Naïve to Biologic
Disease-modifying Anti-rheumatic Drugs2023-506256-25-00Bristol Myers Squibb International Corporation326
招募中
3 期
Vorasidenib for the treatment of IDH-mutant astrocytoma after standard chemoradiotherapy2024-519404-27-00Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi247
进行中（未招募）
2 期
Neoadjuvant Sunvozertinib in Stage II-IIIB Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation.NCT07274761Shanghai Pulmonary Hospital, Shanghai, China24