A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-Center Study to Evaluate the Efficacy and Safety of nemolizumab in Japanese Infant and Pediatric Atopic Dermatitis Patients with moderate to severe pruritus

JRCT ID: jRCT2031230174

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pruritus of atopic dermatitis which is inadequately controlled by the currently available therapy
• Date of first enrollment: 25/06/2023
• Target sample size: 70
• Study type: Interventional
• Intervention(s): subcutaneous administration

Outcome(s)

• Primary Outcome: Change from baseline in itch score weekly average at Week16

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: < 10age old
• Gender: Both

Include criteria

History of inadequate response of pruritus to Topical corticosteroids or Topical calcineurin inhibitor of appropriate class with fixed-dose regimen for >=4 weeks for atopic dermatitis within the past 1 year
History of inadequate response of pruritus to antihistamines or antiallergics with fixed-dose regimen/dosage for >=2 weeks for pruritus of atopic dermatitis within the past 1 year
Patients who are appropriately receiving base treatment for atopic dermatitis.

Exclude criteria

Patients with hepatitis B virus or hepatitis C virus, or whose parents are infected
Patients with tuberculosis or suspected of tuberculosis infection
Patients with immune deficiency
Patients with a history or complication of hypersensitivity to immunoglobulin products
Patients complicated with moderate or severe persistent asthma.

Related Information

• Primary Sponsor: Nishiura Tomoyuki