Clinical Trials in the UK / NCT06988605
Recruiting
Observational
Real-world Experience Using Nemolizumab in the Treatment of Moderate-to-Severe Atopic Dermatitis in Adolescents & Adults
NCT06988605 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Atopic Dermatitis
Study summary
The main aim of the study is to assess real-world effectiveness of nemolizumab in Atopic Dermatitis (AD) as measured by physician assessment and patient reported outcome (PRO) in clinical practice at Month 6.
Eligibility
Inclusion Criteria:
* Participants who, according to the treating physician's decision and in line with the local package label, start treatment with nemolizumab (Nemluvio®).
* Adolescent and adult participants aged \>=12 years with moderate-to-severe AD.
* Participants who signed the written informed consent form (ICF) or had it signed by their legal representative.
Exclusion Criteria:
* Have contraindication(s) for the use of nemolizumab (Nemluvio®) according to the local package label.
* Participants who received treatment with a drug under clinical development/investigation within 3 months prior to baseline.
* Participants who received nemolizumab previously.
* Participants who are mentally, physically, or linguistically unable to understand the content of the ICF and/or to complete the study questionnaires.
Primary outcome measure(s)
- Investigator Global Assessment (IGA) at Month 6 — At Month 6
The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the investigator or trained designee to evaluate the global severity of AD and the clinical response to a treatment. - Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6 — At Month 6
The PP NRS is a single question validated PRO assessment that participants will use to report the maximum intensity of their pruritus (itch). The PP NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Here, a lower score indicates a better outcome.
Trial sites (108)
| Facility | City | Region | Status |
|---|---|---|---|
| Galderma Investigational Site - 8893 | Birmingham | Alabama | Active Not Recruiting |
| Galdrma Investigational Site - 7077 | Phoenix | Arizona | Recruiting |
| Galderma Investigational Site 7060 | Phoenix | Arizona | Recruiting |
| Galderma Investigational Site - 8535 | Phoenix | Arizona | Recruiting |
| Galderma Investigational Site - 7067 | Tucson | Arizona | Not Yet Recruiting |
| Galderma Investigational Site - 7074 | Corona | California | Not Yet Recruiting |
| Galderma Investigational Site 8636 | Fountain Valley | California | Not Yet Recruiting |
| Galderma Investigational Site 8224 | Fremont | California | Recruiting |
| Galderma Investigational Site 7099 | Los Angeles | California | Not Yet Recruiting |
| Galderma Investigational Site 8553 | Newport Beach | California | Recruiting |
| Galderma Investigational Site 7064 | Santa Monica | California | Not Yet Recruiting |
| Galderma Investigational Site 7107 | Thousand Oaks | California | Not Yet Recruiting |
| Galderma Investigational Site 7061 | Castle Rock | Colorado | Not Yet Recruiting |
| Galderma Investigational Site 7059 | Fairfield | Connecticut | Recruiting |
| Galderma Investigational Site 8597 | Boca Raton | Florida | Not Yet Recruiting |
| Galderma Investigational Site 7087 | Coral Gables | Florida | Not Yet Recruiting |
| Galderma Investigational Site 7063 | Cutler Bay | Florida | Recruiting |
| Galderma Investigational Site 7134 | Hollywood | Florida | Recruiting |
| Galderma Investigational Site 7101 | Jupiter | Florida | Not Yet Recruiting |
| Galderma Investigational Site 7078 | Miami | Florida | Recruiting |
| Galderma Investigational Site 7070 | North Miami Beach | Florida | Not Yet Recruiting |
| Galderma Investigational Site 7112 | Oakland Park | Florida | Not Yet Recruiting |
| Galderma Investigational Site 7090 | St. Petersburg | Florida | Recruiting |
| Galderma Investigational Site 7054 | Tampa | Florida | Recruiting |
| Galderma Investigational Site 7058 | Chicago | Illinois | Recruiting |
| Galderma Investigational Site 8142 | Indianapolis | Indiana | Recruiting |
| Galderma Investigational Site 7083 | West Lafayette | Indiana | Not Yet Recruiting |
| Galderma Investigational Site 7098 | Columbia | Maryland | Recruiting |
| Galderma Investigational Site 8012 | Glenn Dale | Maryland | Recruiting |
| Galderma Investigational Site 7068 | Rockville | Maryland | Recruiting |
| Galderma Investigational Site 7065 | Brighton | Massachusetts | Recruiting |
| Galderma Investigationa Site 7104 | Milford | Massachusetts | Recruiting |
| Galderma Investigational Site 7066 | Auburn Hills | Michigan | Not Yet Recruiting |
| Galderma Investigational Site 7071 | Caledonia | Michigan | Recruiting |
| Galderma Investigational Site 7108 | Grandville | Michigan | Not Yet Recruiting |
| Galderma Investigational Site 7072 | Troy | Michigan | Not Yet Recruiting |
| Galderma Investigational Site 7057 | Lee's Summit | Missouri | Recruiting |
| Galderma Investigational Site 8848 | Las Vegas | Nevada | Recruiting |
| Galderma Investigational Site 7055 | Portsmouth | New Hampshire | Recruiting |
| Galderma Investigational Site - Site 7080 | Auburn | New York | Recruiting |
+ 68 more sites — see the full list on the official registry below.
More Galderma R&D trials in the UK
A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)
Active, not recruiting
Other trials for the same condition
A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis
Active, not recruiting
A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis
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 NCT06988605 on ClinicalTrials.gov ↗ ← All trials in the UK