Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Tina Bhutani

Description

Summary

Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

Official Title

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Details

Long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD

Keywords

Moderate-to-Severe Atopic Dermatitis Dermatitis, Atopic Dermatitis Eczema Nemolizumab

Eligibility

You can join if…

Open to people ages 12 years and up

  1. Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD
  2. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

You CAN'T join if...

  1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject.
  2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
  3. Body weight < 30 kg
  4. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods.
  5. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
  6. Any clinically significant issue, based investigator judgement

Locations

  • Galderma Investigational Site not yet accepting patients
    San Francisco California 94115 United States
  • Galderma Investigational Site not yet accepting patients
    Fremont California 94538 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Galderma R&D
ID
NCT03989206
Phase
Phase 3
Study Type
Interventional
Last Updated