ong-Term Extension Study (AtDvance) to Evaluate the Safety and Efficacy of GSK1070806 in Participants with Moderate to Severe Atopic Dermatitis.
- Conditions
- Dermatitis, AtopicTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-508474-29-00
- Lead Sponsor
- Glaxosmithkline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 158
Participants with a diagnosis of moderate to severe AtD who have completed the qualifying Ph2 parent GSK AtD studies, who, in the opinion of the investigator, may benefit from treatment with GSK1070806. Participant must be 18 years of age inclusive, or older at the time of signing the informed consent. Participant must sign and date an informed consent. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Had study intervention permanently discontinued at any time during a qualifying Ph2 parent GSK AtD clinical study, or developed a medical condition that would preclude participation as per qualifying Ph2 parent GSK AtD clinical study protocol. Participants who, during their participation in qualifying Ph2 parent GSK AtD clinical study, developed an AE or an SAE based on laboratory parameters, physical examination, vital signs, ECG, medical history, which in the opinion of the Investigator could indicate that continued treatment with IMP may present an unreasonable risk for the participant.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method