Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.
This is a 24-week randomized, double-blind, placebo-controlled Phase 2 clinical study with a 28-week extension to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 3 dose levels of solrikitug versus placebo on top of standard of care in adult participants with EoE. Approximately 180 adult participants with EoE will be randomized at approximately 80 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 24-week treatment period followed by a 28-week extension period. The study also includes a post-treatment follow-up period of 16 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
184
Solrikitug low dose subcutaneous injection
Solrikitug mid dose subcutaneous injection
Solrikitug high dose subcutaneous injection
Histological response of peak esophageal eosinophil per HPF count of ≤6
Time frame: Week 24
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score
The DSQ score is calculated over 14-day period and ranges from 0 to 84, with a lower score indicating less severe dysphagia.
Time frame: Week 24
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: To Week 24
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Placebo subcutaneous injection
Research Site 1039
Dothan, Alabama, United States
Research Site 1018
Glendale, Arizona, United States
Research Site 1018
Peoria, Arizona, United States
Research Site 1037
Scottsdale, Arizona, United States
Research Site 1003
Tucson, Arizona, United States
Research Site 1023
Englewood, California, United States
Research Site 1005
Irvine, California, United States
Research Site 1015
San Diego, California, United States
Research Site 1034
Aurora, Colorado, United States
Research Site 1027
Cromwell, Connecticut, United States
...and 63 more locations