Long-Term Extension Study (AtDvance) to Evaluate the Safety and Efficacy of GSK1070806 in Participants With Moderate to Severe Atopic Dermatitis.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 52
- 主要终点
- Number of participants with Adverse event (AE)
研究概览
简要总结
The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).
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)
盲法说明
This is a double blinded study until the qualifying parent study has reported out.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must sign and date the consent document.
- •Participants diagnosed with moderate to severe Atopic dermatitis (AtD) who have completed the qualifying Phase 2 parent study (NCT05999799) of GlaxoSmithKline (GSK's) AtD and, in their opinion, may benefit from GSK
- •Be intentional and able to visit the doctor at the clinic by appointment and follow all procedures related to research studies and questionnaires (able to read and understand Patient-reported outcomes (PRO) questionnaires and be able to use electronic devices).
- •The use of contraceptive methods for females should be consistent with local regulations on contraceptive methods of participants participating in clinical research programs.
- •Female participants are eligible to participate in the research program if they are not pregnant or breastfeeding and meet one of the following conditions:
- •It is Woman of nonchildbearing potential (WONCBP).
- •It is Woman of childbearing potential (WOCBP) and uses a highly effective contraceptive method that has a failure rate less than (<) 1 percent (%) during the trial dose period and for at least 16 weeks after the last dose of the research drug. We should assess the likelihood of contraceptive failure (e.g., non-cooperation, early contraception) associated with the first dose of the drug.
- •WOCBP must obtain a negative result in a highly sensitive pregnancy test (by urine or serum test, as prescribed by local regulations) before receiving the first dose of the research drug.
- •If the urine test is positive, or the negative result cannot be confirmed (i.e., the result is unclear), a pregnancy test by serum test is required. In such cases, If the serum is tested, the test result is positive. Participants must be excluded from the research project.
- •Additional requirements for testing pregnancy during and after exposure to the drug.
- •The researcher is responsible for examining medical history, menstrual cycle history, and sexual activity in the near term. To reduce the risk of screening pregnant women who may not be detected at the beginning of pregnancy.
排除标准
- •Permanent discontinuation of the study drug at any time during GSK's qualifying Phase 2 AtD (NCT05999799) or a medical condition that would hinder GSK's participation in the Phase 2 219538 (NCT05999799) AtD research project.
- •Participants who, during GSK's qualifying Phase 2 (NCT05999799) AtD research project, developed adverse event (AE) or Serious adverse event (SAE) based on laboratory parameters, physical examination, vital signs, Electrocardiogram (ECG), medical history, etc. Medical history, in the opinion of the researchers, suggests that if Investigational medicinal product (IMP) is continued, it may cause unnecessary risk to the participants.
- •Topical medications for AtD within 1 week prior to your appointment at Day 1, such as: Topical calcineurin inhibitors (TCI)/ Topical corticosteroids (TCS), Phosphodiesterase-4 (PDE-4) and Janus activation kinase inhibitors (JAKi) for external use.
- •Topical corticosteroids (TCS) (such as hydrocortisone, betamethasone)
- •Topical calcineurin inhibitors (TCI) (such as tacrolimus, pimecrolimus)
- •Phosphodiesterase-4 (PDE4) inhibitor for external use (e.g., crisaborole)
- •JAKi for external use (e.g. ruxolitinib)
- •Medications for topical use, or other herbal/traditional medicines that may affect the AtD that the participants are in.
- •Participant who received systemic therapy, which is considered contraindicated, including systemic therapy used as a rescue medication for AtD, from the screening for GSK's Phase 2 AtD 219538 research project until the LTE protocol began, were unable to participate in the research project.
- •Chronic uncontrolled diseases that may require immediate oral corticosteroids, such as severe uncontrolled asthma (defined as having an Asthma control questionnaire (ACQ)-5 score greater than or equal to (>=) of 1.5 or a history of asthma exacerbations. >= 2 times within the last 12 months, requiring systemic corticosteroid [oral and/or intravenous medication] or requiring a >-24-hour hospital stay)
- •Experience participating in previous/current clinical research projects.
- •The participants have participated in any other clinical research studies. This is in addition to GSK's Phase 2 219538 (NCT05999799) research project.
研究组 & 干预措施
Placebo/GSK1070806 Dose Level 4
Participants were previously treated with placebo in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.
干预措施: GSK1070806 (Drug)
GSK1070806 Dose Level 1/GSK1070806 Dose Level 1
Participants were previously treated with GSK1070806 dose level 1 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 1 SC injection in this LTE study. Dose level 1 is the lowest dose level.
干预措施: GSK1070806 (Drug)
Placebo/Placebo
Participants were previously treated with placebo in parent Study 219538 (NCT05999799) and continued on placebo subcutaneous (SC) injection in this long-term extension (LTE) study.
干预措施: Placebo (Drug)
Placebo/GSK1070806 Dose Level 4
Participants were previously treated with placebo in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.
干预措施: Placebo (Drug)
GSK1070806 Dose Level 4/GSK1070806 Dose Level 4
Participants were previously treated with GSK1070806 dose level 4 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.
干预措施: GSK1070806 (Drug)
GSK1070806 Dose Level 1/GSK1070806 Dose Level 4
Participants were previously treated with GSK1070806 dose level 1 in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.
干预措施: GSK1070806 (Drug)
GSK1070806 Dose Level 2/GSK1070806 Dose Level 2
Participants were previously treated with GSK1070806 dose level 2 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 2 SC injection in this LTE study. Dose level 2 is greater than dose level 1.
干预措施: GSK1070806 (Drug)
GSK1070806 Dose Level 2/GSK1070806 Dose Level 4
Participants were previously treated with GSK1070806 dose level 2 in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.
干预措施: GSK1070806 (Drug)
GSK1070806 Dose Level 3/GSK1070806 Dose Level 3
Participants were previously treated with GSK1070806 dose level 3 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 3 SC injection in this LTE study. Dose level 3 is greater than dose level 2.
干预措施: GSK1070806 (Drug)
GSK1070806 Dose Level 3/GSK1070806 Dose Level 4
Participants were previously treated with GSK1070806 dose level 3 in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.
干预措施: GSK1070806 (Drug)
结局指标
主要结局
Number of participants with Adverse event (AE)
时间窗: Up to Week 280 (End of study [EoS])
An AE is any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product.
Number of participants with AE leading to discontinuation of GSK1070806
时间窗: Up to Week 280 (EoS)
An AE leading to discontinuation of GSK1070806 will be reported.
Number of participants with Serious adverse event (SAE)
时间窗: Up to Week 280 (EoS)
Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAE.
Number of participants with adverse event of special interest (AESI)
时间窗: Up to Week 280 (EoS)
AESI for GSK1070806 include serious infections, opportunistic infections, serious hypersensitivity reactions and injection site reactions (ISRs).
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to Week 59
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state. Safety Analysis Set included all assigned participants who received at least 1 dose of study intervention in this LTE study. Participants were analyzed according to the intervention they actually received.
Number of Participants With TEAEs Leading to Permanent Discontinuation
时间窗: Up to Week 59
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state. Number of participants with TEAE leading to permanent discontinuation of GSK1070806 were reported.
Number of Participants With Serious Adverse Events (SAEs)
时间窗: Up to Week 59
An SAE is defined as any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), is a suspected transmission of any infectious agent via an authorized medicinal product, and medically important were categorized as SAE.
Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESI)
时间窗: Up to Week 59
AESI for GSK1070806 include serious infections, opportunistic infections, serious hypersensitivity reactions, and injection site reactions (ISRs). A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state.
次要结局
- Number of Participants Achieving Investigators Global Assessment (IGA) score of 0 or 1 at Week 16, 32, 48 and up to Week 280 (EoS)(Week 16, 32, 48 and up to Week 280 (EoS))
- Number of participants Achieving Eczema Area and Severity Index (EASI) reduction of greater than or equal to (>=) 75 percent (%) at Week 16, 32, 48 and up to Week 280 (EoS)(Week 16, 32, 48 and up to Week 280 (EoS))
- Number of participants with decreased Peak Pruritus Numerical Rating Scale (PP-NRS) by >=4 points at Week 16, 32, 48 and up to Week 280 (EoS)(Week 16, 32, 48 and up to Week 280 (EoS))
- Percentage of participants Achieving maintained response for IGA of 0 to 1 at Week 16, 32, 48 and up to Week 280 (EoS)(Week 16, 32, 48 and up to Week 280 (EoS))
- Percentage of participants Achieving maintained response for EASI reduction to >= 75% at Week 16, 32, 48 and up to Week 280 (EoS)(Week 16, 32, 48 and up to Week 280 (EoS))
- Percentage change from Baseline in EASI at week 16, 32, 48 and up to Week 280 (EoS)(Week 16, 32, 48 and up to Week 280 (EoS))
- Number of Participants Who Achieved Reduction of >=4 Points in Peak Pruritus Numerical Rating Scale (PP-NRS) Score From Baseline at Weeks 16, 32, and 48(Baseline (Day -7 to Day -1 from the parent study), Weeks 16, 32, and 48)
- Number of Participants Who Achieved Investigators Global Assessment (IGA) Response (IGA Score of 0 or 1 and a Reduction of Greater Than or Equal to [>=]2 Points From Baseline) at Weeks 16, 32, and 48(Baseline (Day 1 from the parent study), Weeks 16, 32, and 48)
- Number of Participants Who Achieved Reduction of Greater Than or Equal to (>=) 75 Percent (%) in Eczema Area and Severity Index (EASI) Score From Baseline at Weeks 16, 32 and 48(Baseline (Day 1 from the parent study), Weeks 16, 32 and 48)
- Number of Participants Who Maintained IGA Response (IGA Score of 0 or 1 and a Reduction of >=2 Points From Baseline) at Weeks 16, 32, and 48(Baseline (Day 1 from the parent study), Weeks 16, 32, and 48)
- Number of Participants Who Maintained Response of Reduction of >= 75% in EASI Score From Baseline at Weeks 16, 32, and 48(Baseline (Day 1 from the parent study), Weeks 16, 32, and 48)
- Percent Change From Baseline (CFB) in EASI Score at Weeks 16, 32, and 48(Baseline (Day 1 from the parent study), Weeks 16, 32, and 48)