Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    1300
  • sponsor
    Galderma R&D
Updated on 8 September 2021
Investigator
Galderma R&D
Primary Contact
Galderma Investigational Site (6.2 mi away) Contact
+477 other location

Summary

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

Description

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

Details
Condition Moderate to Severe Atopic Dermatitis
Treatment Nemolizumab
Clinical Study IdentifierNCT03989206
SponsorGalderma R&D
Last Modified on8 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD
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

Exclusion Criteria

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
Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study
Body weight < 30 kg
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
History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
Any clinically significant issue, based investigator judgement
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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