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

Conditions

• Atopic Dermatitis
• Eczema

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Amlitelimab — DRUG
  Pharmaceutical form: Injection solution Route of administration: Subcutaneous
• Placebo — DRUG
  Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Study Details

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.

Key Dates

Start date

Dec 13, 2021

Status verified

Jun 2025

Primary completion

Apr 26, 2023

Completion

Feb 21, 2024

Study Design

Enrollment

390 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 250mg (500mg Loading Dose) KY1005
  Every 4 weeks
• Experimental: 250mg (No Loading Dose) KY1005
  Every 4 weeks
• Experimental: 125mg KY1005
  Every 4 weeks
• Experimental: 62.5mg KY1005
  Every 4 weeks
• Placebo Comparator: Placebo
  Every 4 weeks

Primary Outcome Measure

Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1) [ Time Frame: Baseline to week 16 ]

Locations (20)

Find similar trials in Fremont, CA

Related Studies

• Studies of Skin Microbes in Healthy People and in People With Skin Conditions
  Recruiting · National Human Genome Research Institute (NHGRI) · Bethesda, Maryland
• Effects of Treatments on Atopic Dermatitis
  PHASE2 · Recruiting · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Bethesda, Maryland
• Natural History and Genetics of Food Allergy and Related Conditions
  Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland
• An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
  Recruiting · Regeneron Pharmaceuticals · Boston, Massachusetts