A multicenter, randomized, double-blind, placebo controlled, dose-range Phase IIb study to assess the efficacy and safety of GIA632 in participants with moderate to severe cutaneous lichen planus, followed by an optional open-label extension period
About this study
This study is testing a new investigational medication (GIA632) to see how well it works and how safe it is for people with cutaneous lichen planus (cLP) that is not well controlled with topical treatments. Participants will be randomly assigned to receive different doses of either the study medication or a placebo (inactive treatment). The study includes a treatment period of 16 weeks, with the option to continue into a longer extension period, plus a mandatory follow-up for safety.
Who is eligible to participate?
- Adults with moderate to severe cutaneous lichen planus (cLP)
- Symptoms not adequately controlled with topical treatments or in individuals who are not suitable to use topical treatment
Disease affecting multiple areas of the body or a larger area of skin, as assessed by the study doctor at the start of the study
Please note, other eligibility criteria may apply.
What is involved?
- Screening tests to check eligibility
- Regular clinic visits throughout the study
- Injections of the study medication or placebo
- Monitoring your health, symptoms, and any side effects
- Participation in a 16‑week core treatment period, with the option to continue into a longer extension period. A safety follow-up period will take place either after the core or extension period for all participants. Total study participation may be up to approximately 18 months, including the extension and safety follow‑up.
Study details
- Novartis Reference No: CGIA632C12201
- HREC Reference Number: HREC/
Contact
Study coordinator Frances Burns | E: dermtrials@alfred.org.au | T: 03 9076 8592