CTRI/2022/04/042014进行中（未招募）2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Trial to Evaluate the Efficacy and Safety of ASLAN004 in Patients with Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female patients, who are 12 years or older and weighing at least 40 kg (at this time of consent), and provide written informed consent and authorization for release and use of protected health information. Patients who meet the legal age for study participation in their respective country, and are able to read and understand, and willing to sign the informed consent form are considered adults. Refer to Section 7.3.11; 2. Willing and able to comply with clinic visits and study-related procedures 3. Have a clinical diagnosis of chronic AD as per Eichenfield revised criteria of Hanifin and Rajka (Appedix 1, that has been present for at least 1 year prior to the Screening visit 4. Have an vIGA score of greater than or equal to 3 (5 point scale, 0-4) at the Screening and Baseline visits; 5. Have greater than or equal to 10% BSA of AD involvement at the Screening and Baseline visits; 6. Have an EASI score =16 at the Screening and Baseline visits; 7. Have a history of inadequate response to, intolerance to or contraindication to a stable (=1 month) regimen of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) as treatment for AD 8. HHave applied, twice daily, a consistent amount of a topical emollient (moisturizer) as approved by the investigator, for at least 7 days prior to randomization;
排除标准
- •1.Immunosuppressive/immunomodulating drugs, systemic therapies or phototherapy within 4 weeks prior to randomization.
- •2.Have had treatment with leukotriene inhibitors within 4 weeks prior to randomization unless in the opinion of the investigator will not impact the study assessments
- •3.Treatment with topical therapies (including TCS, TCI, topical phosphodiesterase inhibitors, topical JAK inhibitors) or prescription moisturizers, within 1 week prior to randomization
- •4.Previous treatment at any time prior to randomization with monoclonal antibody / biologic therapeutic agents as follows:
- •a. Prior exposure to dupilumab (Dupixent®) which was discontinued due to lack of efficacy, loss of response, or adverse event.
- •b.Investigational or approved agents targeting interleukins IL-4 or IL-13 ligands or receptors of IL-4 or IL-13, including but not limited to lebrikizumab, tralokinumab or ASLAN004
- •c.Other investigational or approved biologic drug within 16 weeks or within 5 half-lives (if known), whichever is longer, prior to the Baseline visit.
- •d.Cell-depleting biologics, including, but not limited to, rituximab within 6 months prior to the Baseline visit.
- •5.Inadequate organ function, abnormal lab result, uncontrolled blood pressure or other health condition considered clinically significant by the investigator at the Screening visit.
- •6.History of HIV, Hepatitis B, Hepatitis C or active/latent Tuberculosis infection;
- •7.History of immunosuppression including history of invasive opportunistic infections;
- •8.Treatment with live attenuated vaccine within 8 weeks prior to randomization;
- •9.Parasitic infection within 4 weeks prior to randomization travel within 3 months prior to randomization to areas of high parasitic exposure;
- •10.Have skin comorbidities that in the opinion of the Investigator may interfere with study assessments;
- •11.Female individuals who do not comply with the following contraception requirements: A female individual is not eligible to participate if she is pregnant or breastfeeding, or is a woman of childbearing potential (WOCBP) at risk for pregnancy who is not using two forms of effective birth control during the intervention period and for at least 12 weeks after the last dose of study medication as outlined in Appendix 14. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. Women in the following categories are not considered WOCBP: a. Premenarchal. b. Premenopausal female with 1 of the following: • Documented hysterectomy; • Documented bilateral salpingectomy; • Documented bilateral oophorectomy. For individuals with permanent infertility due to an alternate medical cause other than the above, (eg, Müllerian agenesis, androgen insensitivity), Investigator discretion should be applied to determine study entry. Note: Documentation for any of the above categories can come from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview. The method of documentation should be recorded in the participant’s medical record for the study. c. Postmenopausal female: • A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusio
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectioCrohn’s DiseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2019-000886-19-ATMillennium Pharmaceuticals, Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)96
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Long-Term Safety of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults taking Opioid Therapy for Persistent Non-Cancer PaiEUCTR2005-001725-28-ATGlaxoSmithKline R & D Limited750
进行中（未招募）
1 期
A Phase 2b study to demonstrate the safety and efficacy of Tildrakizumab in patients with Active Psoriatic ArthritisMedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000018188Psoriatic ArthritisEUCTR2016-003937-62-HUSUN Pharma Global FZE360
进行中（未招募）
1 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 in Subjects with Type 2 Diabetes MellitusMedDRA version: 14.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersType 2 Diabetes MellitusEUCTR2012-002414-39-ITMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.4,202
已完成
2 期
A Study to Evaluate the Safety and Efficacy of Anamorelin HCL in Patients with Non Small Cell Lung CancerCTRI/2011/091/000299Helsinn Therapeutics US Inc228