EUCTR2024-000164-37-Outside-EU/EEA
Active, not recruiting
Phase 1
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 sitesApril 9, 2024
ConditionsAtopic DermatitisMedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
Drugsdupixent
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- Sanofi (China) Investment Co., Ltd, Shanhai Branch
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Dupilumab-PEdiatric skin barrier function and LIpidomics STudy in patients with Atopic DermatitisAtopic dermatitisMedDRA version: 20.0Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2020-001518-40-GBSanofi Aventis Recherche & Developpement48
Active, not recruiting
Phase 1
Dupilumab skin BArrier function and Lipidomics study in Atopic DermatitisAtopic dermatitisMedDRA version: 20.0Level: PTClassification code 10012438Term: Dermatitis atopicSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]EUCTR2020-000314-15-Outside-EU/EEASanofi-Aventis Recherche & Développement
Active, not recruiting
Phase 1
Investigation on the effect and tolerability of erenumab in posttraumatic headachePost-traumatic headacheMedDRA version: 20.0Level: LLTClassification code 10019222Term: Headache post-traumaticSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2018-003943-46-DKDanish Headache Center100
Active, not recruiting
Phase 1
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
Active, not recruiting
Phase 1
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 disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2015-005597-38-DKF. Hoffmann-La Roche Ltd680