A Study to Evaluate VTX2735 in Patients With Cryopyrin-associated Periodic Syndrome
Completed · Phase 2
Conditions studied: Cryopyrin Associated Periodic Syndrome
In brief
This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Cryopyrin-Associated Period Syndrome (CAPS). Approximately 10 patients will take VTX2735 Dose A or VTX2735 Dose B. The study consists of a screening/washout period of up to 28 weeks, a 2 week treatment period, a treatment withdrawal period of up to 2 weeks, another 2 week treatment period, and a 4 week follow up period. The maximum length of treatment is 4 weeks.
Key facts
- Study ID
- NCT05812781
- Run by
- Zomagen Biosciences Ltd.
- People needed
- 7
- Starts
- 2023-03-18
- Expected to finish
- 2024-03-06
- Last updated by the study team
- 2025-03-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least 18 years of age
- Diagnosis of CAPS and FCAS subtype and mild clinical phenotype
- At least one flare during screening/washout
- Women must not be of childbearing potential or must agree to use two methods of highly effective contraception during the study and for 30 days after the last dose of the study product
- Men with a partner who is of childbearing potential must agree to use condoms plus another highly effective form of birth control during the study and for 90 days after the last dose of study product
You may not qualify if…
- Unwilling to comply with washout of anti-IL-1 therapy and tolerate symptoms of disease flare
- Moderate or severe CAPS manifestations or significant damage or any CAPS feature that presents a contraindication to washout of anti-IL-1 therapy
- Has a history of chronic or recurrent infectious disease
- Has a known immune deficiency or is immunocompromised
- Has hepatitis B or hepatitis C infection, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or active tuberculosis (TB)
- Has another clinically important medical disorder that would compromise safety
Where it is running
- Local Site # 222 — San Diego, California, United States
- Local Site # 223 — Columbus, Georgia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.