An observational study in Atopic Dermatitis, sponsored by Galderma R&D. Recruiting at 108 sites in 3 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by Galderma R&D (part of Galderma Group AG) · Observational
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Among 17 studies in Dermatitis, Atopic by Galderma Group AG — 3 open to participants now, 3 under way, 1 of them phase 3. Dermatitis, Atopic · Galderma Group AG.
Among the 17 studies in Dermatitis, Atopic by Galderma Group AG, this one is the only one that started in 2025, is the only observational one, and was the 15th registered.
1,592 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
Browse Dermatitis, Atopic studies →3 of the 17 studies in Dermatitis, Atopic by Galderma Group AG are open now, in 4 countries. Recruiting first, the newest first:
Galderma R&D · Sites in China
Ages 12+
Galderma R&D · Sites in United States
Ages 6 mo–23 mo
By country, each count listing its studies:
Of the 193 Dermatitis, Atopic studies recruiting now, 83 (43%) set no upper age limit and 94 (49%) stop at 75 or younger; 93 take children under 18; 51 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2025.
This study's planned enrollment of 1,000 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.
Median enrollment 115 across the 16 interventional studies, 1,000 across the 1 observational. Of the 13 that completed or were terminated, 11 (85%) have results posted.
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This study is registered under Galderma R&D, one of the names counted as Galderma Group AG. Under that name alone:
Galderma R&D is the lead sponsor of 284 studies on the registry; 11 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 55 (92%) have results posted.
1 of the studies in Dermatitis, Atopic by Galderma Group AG that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07762833Phase 3Galderma R&DRandomized, Double-blind, Placebo-controlled Study of Nemolizumab in Chinese Subjects With Moderate-to-severe Atopic Dermatitis | 2027-10-28 |
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Among the 17 studies in Dermatitis, Atopic by Galderma Group AG, from their registry updates:
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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.
This prospective, multicenter, non-interventional study (NIS) seeks to evaluate treatment with nemolizumab of moderate-to-severe AD in adolescents and adults over an approximately 12-month period using physician assessments in routine clinical practice and PRO measures.
Treatment with nemolizumab will be determined solely by the participant's physician prior to study enrollment. No additional visits, procedures, or laboratory tests are required outside of routine clinical practice. The visit structure is not defined by the study protocol but is determined by routine medical practice. The visit schedule is intended to facilitate a systematic data assessment according to clinical routine. A sub-study will be completed in Germany and the UK at selected sites in which participants will complete the Peak Pruritus (PP) Numerical Rating Scale (NRS), Average Pruritus (AP) NRS, Sleep Disturbance (SD) NRS, and Pain NRS on a daily basis from Day -1 to Day 14. Data collection will occur remotely, and no clinic visits will be required.
The clinical decision for treatment with nemolizumab has to be made by the physicians independently of the participation in this NIS and prior to the informed consent process. Participants greater than or equal to (>=) 12 years of age will be eligible for the trial.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with moderate-to-severe AD who are receiving nemolizumab (Nemluvio®) in routine clinical practice will be observed for approximately 12 months.
Investigator Global Assessment (IGA) 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.
Time frame: At Month 6
Peak Pruritus Numerical Rating Scale (PP NRS) 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.
Time frame: At Month 6
Eczema Area and Severity Index (EASI) up to Month 12
The EASI is a validated measure commonly used in clinical trials and clinical practice to assess the severity and the extent of AD signs. The EASI score is a composite score ranging from 0 to 72. The severity of erythema, induration/papulation, excoriation, and lichenification will be assessed by the investigator or trained designee on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. In addition, the extent of AD involvement in each of the 4 body areas will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. A higher score indicates severe AD.
Time frame: Up to Month 12
Scoring Atopic Dermatitis (SCORAD) up to Month 12
The SCORAD is a validated measure commonly used in clinical trials and clinical practice to assess the severity and the extent of AD signs and symptoms. The SCORAD ranges from 0 to 103 and has 3 components: extent, intensity, and patient-reported symptoms of pruritus and sleep loss. The investigator or trained designee will assess the severity of 6 signs of AD (erythema, edema/papulation, oozing/crust, excoriation, lichenification, and dryness), each on a scale ranging from 0 (absence) to 3 (severe). The investigator or trained designee will also ask the participant to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a visual analogue scale (VAS) from 0 to 10. A higher score indicates severe AD.
Time frame: Up to Month 12
Investigator Global Assessment (IGA) up to Month 12
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.
Time frame: Up to Month 12
Peak Pruritus Numerical Rating Scale (PP NRS) up to Month 12
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.
Time frame: Up to Month 12
Average Pruritus Numerical Rating Scale (AP NRS) up to Month 12
The AP NRS is a single question assessment that participants will use to report the average intensity of their pruritus (itch). The AP 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 overall during the previous 24 hours?". Here, a lower score indicates a better outcome.
Time frame: Up to Month 12
Sleep Disturbance Numerical Rating Scale (SD NRS) up to Month 12
The SD NRS is a single-item PRO for quantifying sleep disturbance. The SD NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (atopic dermatitis)' and 10 being 'I did not sleep at all due to the symptoms of my skin disease (atopic dermatitis)', how would you rate your sleep last night?". Here, a lower score indicates a better outcome.
Time frame: Up to Month 12
Pain Numerical Rating Scale (Pain NRS) up to Month 12
The Pain NRS is a single-item assessment with a potential follow-up question that participants will use to report the average intensity of their pain. The Pain NRS consists of the following question: "Over the past 24 hours, how severe was the pain in your skin?". If the participant rates their pain from 1 to 10, then the following question will be asked: "Do you think the pain is part of the itch, from scratching or both?". Here, a lower score indicates a better outcome.
Time frame: Up to Month 12
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Started Jul 2025 (actual). Primary completion is estimated for Nov 2026, 15 months after the start.
Of 74 industry-sponsored observational studies under Dermatitis, Atopic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's planned 15 months is below that.
Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.
How these figures are worked out, and which studies are left out of them.
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