TerminatedPhase 3

Study to Evaluate the Long-Term Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Subjects With GPP

Stopped: AnaptysBio has concluded the GEMINI-2 trial, with all trial participants having been treated with imsidolimab for approximately six months and the furthest subject having been treated through 104 weeks.

United States42 participantsStarted 2022-04-21

Plain-language summary

This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject participated in the preceding placebo-controlled Phase 3 study ANB019-301 and completed at least the Week 1 visit of the ANB019-301 study without the use of rescue/prohibited medication for GPP * Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment Exclusion Criteria: * Use of prohibited medications between the last visit of the ANB019-301 study and the Day 1 visit of the ANB019-302 study

What they're measuring

Incidence of Adverse Events

Timeframe: All Adverse Events (AEs) were collected from Day 1 of 302 up to the final Safety Follow-up Visit (Week 116) regardless of seriousness or relationship to investigational product.

Trial details

NCT IDNCT05366855

SponsorVanda Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-12

Results submitted2026-02-05

View on ClinicalTrials.gov More Generalized Pustular Psoriasis trials