Clinical Trials in Italy / 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 Italy tracker
Condition(s) studied
Moderate-to-Severe Atopic Dermatitis
Study summary
Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description
Eligibility
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)
- Incidence and Severity of TEAEs — Baseline to Week 200
- Incidence of Serious TEAEs — Baseline to Week 200
- Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study — Baseline to Week 200
Trial sites (343)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Italy
A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
Active, not recruiting
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 Italy