EUCTR2024-000164-37-Outside-EU/EEA进行中（未招募）1 期
Open-label exploratory study to evaluate the effect of dupilumab on skin barrier function in Chinese patients with moderate to severe atopic dermatitis - BALISTAD-C
Sanofi (China) Investment Co., Ltd, Shanhai Branch0 个研究点开始时间: 2024年4月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •- Participant must be between 12 to 65 years of age (inclusive), at the time of signing the informed consent.
- •- Male or Female. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •- Willing to refrain from applying any topical medication products on the target assessment areas throughout the study until the EoT visit unless necessary to alleviate intolerable symptoms.
- •- Willing to refrain taking showers or soaking in a bathtub with soaps and body washes within 6 hours before TEWL assessments.
- •- Willing to NOT apply any moisturizers to the areas of the skin that are targeted assessment areas during the entire study from Day -7 to the EoT visit.
- •- Willing and able to comply with all clinic visits and study-related procedures.
- •- Capable of understanding and giving signed informed consent/assent as will be described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For adolescents =12 and <18 years of age a specific ICF must also be signed by the participant’s legally authorized representative.
- •- ATOPIC DERMATITIS PAIENTS ONLY:
- •(1) Patients with AD diagnosis according to Hanifin and Rajka criteria at least 1 year before screening.
- •(2) Investigator Global Assessment (IGA) score of =3 at screening (on the 0-4 scale).
- •(3) Patients with moderate to severe atopic dermatitis that are eligible to be treated with dupilumab according to package insert.
- •(4) Patients with AD must have active lesions on the upper limbs or lower limbs, with severity for lesion erythema or edema/papulation =2 at screening on the 0-3 scale of the ISS.
- •(5) Participants should have a non-lesional (normal looking) skin area 4 cm from the edge of the lesional area. If unable to identify non-lesional skin 4 cm from the lesional area, it is acceptable to identify normal looking skin as close to the lesion as possible.
- •HEALTHY VOLUNTEERS ONLY:
- •(1) Age and gender matched to a selected AD patient by study site. Adolescents aged 12 to 17 years will be matched by post puberty status, and adults aged 18 to 65 years will be matched by age as close as possible within 10 years of age.
- •(2) No current or prior dermatologic or systemic condition that could interfere with the assessments.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 35
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical conditions
- •- Previous treatment with dupilumab within 6 months prior to screening.
- •- Skin conditions other than AD that can confound assessments in the area of TEWL assessments in the opinion of the investigator (ie, skin atrophy, ichthyosis, Netherton syndrome, severe photo damage).
- •- Cracked, crusted, oozing, or bleeding AD lesions in the designated lesional assessment area leaving insufficient skin that is adequate for TEWL assessments.
- •- Ocular disorder that in the opinion of the investigator could adversely affect the individual’s risk for study participation. Examples include -but are not limited to- individuals with a history of active cases of herpes keratitis; Sjogren’s syndrome, keratoconjunctivitis sicca or dry eye syndrome that require daily use of supplemental lubrication; or individuals with ocular conditions that require the use of ocular corticosteroids or cyclosporine.
- •- Systemic AD treatment or phototherapy within 4 weeks of baseline.
- •- Topical AD treatment within 1 week of baseline. Face and neck may be treated with topical steroids during the washout period if approved by the investigator.
- •- Severe prior or concomitant illness(es) that, in the investigator’s judgment, would adversely affect the patient’s participation in the study. Examples include, but are not limited to patients with short life expectancy, patients with uncontrolled diabetes (hemoglobin A1c =9%), patients with cardiovascular conditions (eg, Class III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (eg, patients on dialysis), hepato-biliary conditions (eg, Child-Pugh class B or C), neurological conditions (eg, demyelinating diseases), active major autoimmune diseases (eg, lupus, inflammatory bowel disease, rheumatoid arthritis, etc), other severe endocrinological, gastrointestinal, metabolic, pulmonary, psychiatric (known suicidal intentions),lymphatic diseases, or any illness(es) that resulted in prior or current use of chemotherapy or radiation . The specific justification for patients excluded under this criterion will be noted in study documents (chart notes, electronic case report forms [eCRF], screening logs, etc).
- •- History of hypersensitivity reaction to tape or adhesives.
- •Prior/concomitant therapy
- •- Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known) prior to Day 1, whichever is longer.
- •- Treatment with live (attenuated) vaccine within 4 weeks before the baseline visit.
- •Prior/concurrent clinical study experience
- •- Current participation in another investigational clinical study.
- •Other exclusions
- •- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
- •- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
- •- Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals (in conjunction with section 1.61 of the ICH-GCP Ordinance E6)
- •- Any specific situation during study implementation/course that may raise ethics considerations
- •- Sensitivity to any of the study interventions, or components thereof, or drug or other
研究者
相似试验
进行中（未招募）
1 期
Dupilumab-PEdiatric skin barrier function and LIpidomics STudy in patients with Atopic DermatitisMedDRA version: 20.0Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersAtopic dermatitisEUCTR2020-001518-40-GBSanofi Aventis Recherche & Developpement48
进行中（未招募）
1 期
Dupilumab skin BArrier function and Lipidomics study in Atopic DermatitisMedDRA version: 20.0Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersAtopic dermatitisEUCTR2020-000314-15-Outside-EU/EEASanofi-Aventis Recherche & Développement
进行中（未招募）
1 期
Investigation on the effect and tolerability of erenumab in posttraumatic headachePost-traumatic headacheMedDRA version: 20.0Level: LLTClassification code 10019222Term: Headache post-traumaticSystem Organ Class: 100000004852EUCTR2018-003943-46-DKDanish Headache Center100
进行中（未招募）
1 期
An open label study to evaluate the efficacy and tolerability of erenumab in the management of persistent redness and flushing in rosacea - STOP ROS StudyEUCTR2019-003971-20-DKRigshospitalet Glostrup30
进行中（未招募）
1 期
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisRelapsing remitting multiple sclerosis (RRMS)MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disordersEUCTR2015-005597-38-DKF. Hoffmann-La Roche Ltd680