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Clinical Trials in the UK / NCT03989206
Active, not recruiting Phase 3

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

NCT03989206 · tracked via the Priya Life Science UK tracker
Sponsor
Galderma R&D
Phase
Phase 3
Started
2019-12-30
Last updated
2024-10-30

Condition(s) studied

Moderate-to-Severe Atopic Dermatitis

Investigational drug(s) / intervention(s)

Nemolizumab

Nemolizumab: Nemolizumab

Study summary

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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

Primary outcome measure(s)

Trial sites (343)

FacilityCityRegionStatus
Galderma Investigational Site 8749 Birmingham Alabama
Galderma Investigational Site 8893 Birmingham Alabama
Galderma Investigational Site 8866 Guntersville Alabama
Galderma Investigational Site 8808 Scottsdale Arizona
Galderma Investigational Site 8873 Scottsdale Arizona
Galderma Investigational Site 8447 Fort Smith Arkansas
Galderma Investigational Site 8880 North Little Rock Arkansas
Galderma Investigational Site 8831 Anaheim California
Galderma Investigational Site 8906 Bell Gardens California
Galderma Investigational Site 8456 Beverly Hills California
Galderma Investigational Site 8578 Cerritos California
Galderma Investigational Site 8577 Encinitas California
Galderma Investigational Site 8636 Fountain Valley California
Galderma Investigational Site 8224 Fremont California
Galderma Investigational Site 8791 Fresno California
Galderma Investigational Site 8888 Fullerton California
Galderma Investigational Site 8845 Huntington Beach California
Galderma Investigational Site 8833 Inglewood California
Galderma Investigational Site 8686 Lomita California
Galderma Investigational Site 8674 Los Angeles California
Galderma Investigational Site 8683 Los Angeles California
Galderma Investigational Site 8813 Los Angeles California
Galderma Investigational Site 8907 Newport Beach California
Galderma Investigational Site 8799 Ontario California
Galderma Investigational Site 8745 Pasadena California
Galderma Investigational Site 8671 San Diego California
Galderma Investigational Site 8692 San Diego California
Galderma Investigational Site 8658 San Diego California
Galderma Investigational Site 8125 San Francisco California
Galderma Investigational Site 8536 Santa Ana California
Galderma Investigational Site 8608 Santa Monica California
Galderma Investigational Site 8820 Westminster California
Galderma Investigational Site 8637 Farmington Connecticut
Galderma Investigational Site 8870 Boca Raton Florida
Galderma Investigational Site 8805 Cape Coral Florida
Galderma Investigational Site 8786 Clearwater Florida
Galderma Investigational Site 8902 Doral Florida
Galderma Investigational Site 8391 Hialeah Florida
Galderma Investigational Site 8804 Hialeah Florida
Galderma Investigational Site 8711 Jacksonville Florida

+ 303 more sites — see the full list on the official registry below.

More Galderma R&D trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03989206 on ClinicalTrials.gov ↗ ← All trials in the UK