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Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study

NCT05131477 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2025-07-03

Study results available
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Summary

This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis.

The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the Long-Term Extension (LTE) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.

Conditions

Interventions

DRUG

Amlitelimab

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Kymab Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2023-04-26
Completion
2024-02-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Japan
  • Poland
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT05131477 on ClinicalTrials.gov