A Phase 1/2a Study to Evaluate the Safety and Tolerability of Intravitreal REGN7041 in Patients with Active Noninfectious Uveitis Affecting the Posterior Segment

The primary objective is to evaluate the ocular and systemic safety and tolerability of single and repeated doses of REGN7041, an anti-CD3 monoclonal antibody, administered via intravitreal injection in patients with active noninfectious uveitis affecting the posterior segment. Secondary objectives include:

• Characterization of the pharmacokinetics of intravitreally administered REGN7041.
• Assessment of immunogenicity following administration.

The study involves 24 participants diagnosed with non-infectious uveitis. The study population includes both male and female patients within the age ranges of 3 and 4. Inclusion requires a diagnosis of anterior, intermediate, posterior, or panuveitis, with anterior cases demonstrating inflammation affecting the posterior segment. Participants must exhibit active disease at baseline. Specific visual acuity requirements are defined by best corrected visual acuity (BCVA) measured in ETDRS letters: Part A requires a BCVA between 11 and 65 letters, while Part B requires a BCVA of less than 75 and greater than 10 letters.

This Phase 1/2a study evaluates the ocular and systemic safety and tolerability of REGN7041, an anti-CD3 monoclonal antibody, in patients diagnosed with active noninfectious uveitis affecting the posterior segment. The investigational product is administered as an intravitreal solution for injection. The research methodology involves assessing both single and repeated doses. Primary endpoints include the occurrence of treatment-emergent adverse events, while secondary endpoints consist of REGN7041 concentrations in serum and the incidence and magnitude of anti-drug antibodies. The clinical process begins with a screening visit to confirm the diagnosis and establish baseline best corrected visual acuity according to specific ETDRS letter criteria for Part A or Part B. Following the administration of the study drug, participants undergo subsequent visits to monitor safety and efficacy through the end-of-study visit.

REGN7041 is an anti-CD3 monoclonal antibody provided as a solution for injection. The investigational product is administered via intravitreal injection to evaluate the ocular and systemic safety and tolerability of both single and repeated doses in patients with noninfectious uveitis affecting the posterior segment.

The assessment of efficacy and safety in this study of REGN7041 involves several parameters. The primary endpoint is the occurrence of treatment-emergent adverse events. Secondary assessments include the measurement of REGN7041 concentrations in serum. Additionally, the incidence and magnitude of anti-drug antibodies to REGN7041 in serum will be evaluated.