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A Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherton Syndrome

Netherton Syndrome Clinical Trial

Official title:
A Phase 1b/2, Double-Blind, Placebo-Controlled, Randomized, Parallel-Arm Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherton Syndrome

Clinical Trial Summary

Netherton Syndrome (NS) is a severe rare disease characterized by generalized scaling, erythema, and epidermal barrier defects. This study assessed the safety, pharmacokinetics (PK), and efficacy of DS-2325a in patients with NS.

Clinical Trial Description

This study will explore the safety, pharmacokinetics (PK), and early clinical signal efficacy of DS-2325a in adult patients with NS. The primary objective of the study will be to explore the safety and tolerability of DS-2325a in patients with NS by administering DS-2325a for 12 consecutive weeks (Main Phase, which will be double-blind and during which some participants will receive placebo as a control) and to confirm by administering for an additional 24 weeks (Extension Phase, which will be open-label and during which all participants will receive DS-2325a). Secondary objectives of the study will include exploring the PK properties, efficacy, and immunogenicity of DS-2325a in patients with NS by administering DS-2325a for 12 consecutive weeks (Main Phase) and to confirm by administering for an additional 24 weeks (Extension Phase). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05979831
Study type Interventional
Source Daiichi Sankyo
Contact Daiichi Sankyo Contact for Clinical Information
Phone 908-992-6400
Email CTRinfo@dsi.com
Status Recruiting
Phase Phase 1/Phase 2
Start date September 28, 2023
Completion date November 1, 2024
View Details
See also
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Completed NCT05583669 - A Study to Assess the Safety and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of DS-2325a in Healthy Subjects Phase 1
Completed NCT01428297 - A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome Phase 1
Recruiting NCT05856526 - A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome Phase 2/Phase 3
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Recruiting NCT05521438 - Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome Phase 2/Phase 3
Completed NCT05388903 - A Study to Assess the Safety and Pharmacokinetics of Single Ascending Subcutaneous and Intravenous Doses of DS-2325a in Healthy Subjects Phase 1
Recruiting NCT04244006 - A Pilot Study of the Efficacy and Safety of Dupilumab Versus Placebo in Patients With Netherton Syndrome Phase 2/Phase 3
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