Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata (NCT05589610) | Clinical Trial Compass
CompletedPhase 2
Study of EQ101 in Adult Subjects With Moderate to Severe Alopecia Areata
Australia, New Zealand36 participantsStarted 2022-12-19
Plain-language summary
The purpose of this study is to assess the safety, PK, and PD of EQ101 as well as measure the efficacy of EQ101 at Week 24 compared to Baseline in adult subjects with moderate to severe AA. The study consists of 3 phases: a screening phase of up to 5 weeks, a treatment phase of 24 weeks, and a follow-up phase of 4 weeks. Study drug will be administered via intravenous (IV) push weekly.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓.Subjects have AA, meeting all of the following criteria:
✓. Clinical diagnosis of AA with no other aetiology of hair loss ;
✓. At least 35% scalp hair loss, as defined by a SALT score ≥ 35, at Screening and Baseline. Approximately 25% of subjects with 35% to \<50% scalp hair loss and 25% may have AT/AU.
✓. Current episode of hair loss lasting \> 6 months to \< 7 yrs at time of Screening; and
✓. No appreciable change in terminal hair regrowth within 6 months of the baseline visit.
Exclusion criteria
✕. Known history of, or currently experiencing, male pattern androgenetic alopecia or female pattern hair loss
✕. History of scalp hair transplantation.
✕. Other scalp disease that may impact AA assessment or require topical treatment
✕. Unwilling to maintain a consistent hair style, including shampoo and hair products, and to refrain from weaves or extensions throughout the course of the study, or shaving of scalp.
✕. Use of adhesive or difficult to remove hairpiece or wigs during the study
✕. Have undergone significant trauma or major surgery within 8 weeks of the first dose of study drug or considered in imminent need for surgery or with elective surgery scheduled to occur during the study.