ASP6294 / Astellas - LARVOL DELTA

SERENITY: A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis (clinicaltrials.gov) - P2 | N=119 | Completed | Sponsor: Astellas Pharma Europe B.V. | Phase classification: P2a ➔ P2

Phase classification • Interstitial Cystitis • Musculoskeletal Pain • Pain

A novel anti-NGF PEGylated Fab' provides analgesia with lower risk of adverse effects. (PubMed, MAbs) - "While the anti-NGF IgG promoted edema over time, the anti-NGF PEGylated Fab' did not. The anti-NGF PEGylated Fab' (ASP6294) may thus be a potential therapeutic candidate with lower risk of adverse effects for various diseases in which NGF is involved such as OA and chronic back pain."

Adverse events • Journal • Back Pain • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatoid Arthritis • Rheumatology

SERENITY: A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis (clinicaltrials.gov) - P2a; N=117; Completed; Sponsor: Astellas Pharma Europe B.V.; Active, not recruiting ➔ Completed

Clinical • Trial completion

SERENITY: A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis (clinicaltrials.gov) - P2a; N=117; Active, not recruiting; Sponsor: Astellas Pharma Europe B.V.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

SERENITY: A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis (clinicaltrials.gov) - P2a; N=163; Recruiting; Sponsor: Astellas Pharma Europe B.V.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

SERENITY: A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis (clinicaltrials.gov) - P2a; N=163; Not yet recruiting; Sponsor: Astellas Pharma Europe B.V.

Clinical • New P2a trial