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

• Status: Not yet recruiting
• Trial end date: 2024-05-20
• Target enrollment: 0
• Participant gender: All

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 4±1 weeks of screening and run-in period, followed by a 365 days double blinded treatment period with additional 84 days safety follow-up up to Day 449.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kymab Limited
• Collaborator: Sanofi

Criteria

Inclusion Criteria:

• Adults (18 to < 75 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at Baseline.

• EASI of 12 or higher at the Screening Visit and 16 or higher at Baseline.

• IGA of 3 or 4 at Baseline.

• AD involvement of 10% or more of body surface area (BSA) at Baseline.

• Documented history, within 6 months prior to Baseline, of either inadequate response or inadvisability of topical treatments.

• Must have applied a stable dose of topical bland emollient (simple moisturiser, no additives [e.g., urea]) at least twice daily for a minimum of 7 consecutive days before Baseline.

• Able and willing to provide written informed consent and comply with requested study visits and procedures.

Exclusion Criteria:

• Recent treatment within specific time windows before the baseline visit for the management of atopic dermatitis such as topical or systemic corticosteroids, biologic or investigational therapies and/or phototherapy.

• Known history of or suspected significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.

• Basal and squamous cell skin cancer in the last 3 years prior to Baseline. Any other malignancies in the last 5 years prior to Baseline (excluding in situ cervical carcinoma).

• Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, renal disease, neurological conditions, heart failure and pulmonary disease.

• In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, haematology or urinalysis tests at the Screening Visit.

• Known history of human immunodeficiency virus (HIV) infection

• Concurrent participation in any other clinical study, including non-interventional studies.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.