A Study to Evaluate VTX2735 in Patients With Cryopyrin-associated Periodic Syndrome (Explore)

Zomagen Biosciences Ltd.

Status and phase

Completed

Phase 2

Conditions

Cryopyrin Associated Periodic Syndrome

Treatments

Drug: VTX2735

Study type

Interventional

Funder types

Industry

Identifiers

NCT05812781

VTX2735-201

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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