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

NCT05979831 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-14

Study results available
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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.

Conditions

Interventions

DRUG

DS-2325a

Main Phase and Extension Phase: Loading IV dose followed by maintenance SC doses

OTHER

Placebo

Main Phase: IV infusion followed by SC doses

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-28
Primary Completion
2025-01-06
Completion
2025-01-06
FDA Drug
Yes

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05979831 on ClinicalTrials.gov