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Current Clinical Trials

Sneeze, Wheeze and Itch Associates, LLC

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Moderate to Severe Atopic Dermatitis/Eczema

  • Number
  • Type
  • Age Range
  • Length of Study
  • Compensation*
  • RD.06.SPR.118380
  • Moderate to Severe Atopic Dermatitis/Eczema
  • 12 - 54 years and older
  • ~28 weeks
  • $525

 

*Qualified participants may receive compensation for time and travel, up to the amount listed.

A Randomized, Double-Blind, Placebo-Controlled Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects (≥ 12 to 54 years) with moderate-to-severe AD. Eligible subjects must have a documented history of inadequate response to topical AD medication(s). Approximately 200 subjects will be randomized 1:1 to receive either 30 mg nemolizumab (with a 60 mg loading dose) or placebo, stratified by baseline disease severity (IGA = 3, moderate; IGA = 4, severe). The study consists of a 2- to 4-week screening period, a 16-week treatment period, and an 8-week follow-up period (12 weeks after the last study drug injection).

Inclusion Criteria:

  • Chronic AD for at least 2 years
  • EASI score >= 16
  • IGA score >= 3
  • AD involvement >= 10% of BSA
  • Peak (maximum) pruritus NRS score of at least 4.0

Exclusion Criteria:

  • Body weight < 30 kilogram (kg)
  • History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients
  • History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol
  • Participants for whom administration of the meningococcal vaccine provided in this study is contraindicated or medically inadvisable
  • Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable
  • Receipt of any vaccine (except inactivated influenza vaccine) within 12 weeks prior to screening, any meningococcal vaccine within 1 year prior to screening, or any tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to screening

For more information, please call 309-452-0995 and ask to speak to a coordinator.