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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nemolizumab | Participants with moderate-to-severe AD who are receiving nemolizumab (Nemluvio®) in routine clinical practice will be observed for approximately 12 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Galderma Research and Development | Contact | 817-961-5000 | clinical.studies@galderma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site - 8893 | Active, not recruiting | Birmingham | Alabama | 35244 | United States | |
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| 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. | 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. | 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. | 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. | 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. | 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. | Up to Month 12 |
| Galdrma Investigational Site - 7077 |
| Recruiting |
| Phoenix |
| Arizona |
| 85006-2754 |
| United States |
| Galderma Investigational Site 7060 | Recruiting | Phoenix | Arizona | 85008-3884 | United States |
| Galderma Investigational Site - 8535 | Recruiting | Phoenix | Arizona | 85032-2238 | United States |
| Galderma Investigational Site - 7067 | Not yet recruiting | Tucson | Arizona | 85718 | United States |
| Galderma Investigational Site - 7074 | Not yet recruiting | Corona | California | 92882 | United States |
| Galderma Investigational Site 8636 | Not yet recruiting | Fountain Valley | California | 92708-3701 | United States |
| Galderma Investigational Site 8224 | Recruiting | Fremont | California | 94538-1603 | United States |
| Galderma Investigational Site 7099 | Not yet recruiting | Los Angeles | California | 90024-2801 | United States |
| Galderma Investigational Site 8553 | Recruiting | Newport Beach | California | 92663-3606 | United States |
| Galderma Investigational Site 7064 | Not yet recruiting | Santa Monica | California | 90404-2216 | United States |
| Galderma Investigational Site 7107 | Not yet recruiting | Thousand Oaks | California | 91360-7746 | United States |
| Galderma Investigational Site 7061 | Not yet recruiting | Castle Rock | Colorado | 80109-8034 | United States |
|
| Galderma Investigational Site 7059 | Recruiting | Fairfield | Connecticut | 76824 | United States |
|
| Galderma Investigational Site 8597 | Not yet recruiting | Boca Raton | Florida | 33431-5133 | United States |
| Galderma Investigational Site 7087 | Not yet recruiting | Coral Gables | Florida | 33134-2073 | United States |
| Galderma Investigational Site 7063 | Recruiting | Cutler Bay | Florida | 33157 | United States |
|
| Galderma Investigational Site 7134 | Recruiting | Hollywood | Florida | 33021-6748 | United States |
| Galderma Investigational Site 7101 | Not yet recruiting | Jupiter | Florida | 33477 | United States |
| Galderma Investigational Site 7078 | Recruiting | Miami | Florida | 33173 | United States |
| Galderma Investigational Site 7070 | Not yet recruiting | North Miami Beach | Florida | 33162-4708 | United States |
| Galderma Investigational Site 7112 | Not yet recruiting | Oakland Park | Florida | 33334 | United States |
| Galderma Investigational Site 7090 | Recruiting | St. Petersburg | Florida | 33713-8012 | United States |
| Galderma Investigational Site 7054 | Recruiting | Tampa | Florida | 33609-2230 | United States |
| Galderma Investigational Site 7058 | Recruiting | Chicago | Illinois | 60641 | United States |
| Galderma Investigational Site 8142 | Recruiting | Indianapolis | Indiana | 46250-2041 | United States |
| Galderma Investigational Site 7083 | Not yet recruiting | West Lafayette | Indiana | 47906-1569 | United States |
| Galderma Investigational Site 7098 | Recruiting | Columbia | Maryland | 21045-2336 | United States |
| Galderma Investigational Site 8012 | Recruiting | Glenn Dale | Maryland | 20769-9182 | United States |
| Galderma Investigational Site 7068 | Recruiting | Rockville | Maryland | 20850-6243 | United States |
| Galderma Investigational Site 7065 | Recruiting | Brighton | Massachusetts | 02135 | United States |
|
| Galderma Investigationa Site 7104 | Recruiting | Milford | Massachusetts | 01757 | United States |
| Galderma Investigational Site 7066 | Not yet recruiting | Auburn Hills | Michigan | 48326-3396 | United States |
| Galderma Investigational Site 7071 | Recruiting | Caledonia | Michigan | 49316-7478 | United States |
| Galderma Investigational Site 7108 | Not yet recruiting | Grandville | Michigan | 49418 | United States |
| Galderma Investigational Site 7072 | Not yet recruiting | Troy | Michigan | 48084-5260 | United States |
| Galderma Investigational Site 7057 | Recruiting | Lee's Summit | Missouri | 64064 | United States |
|
| Galderma Investigational Site 8848 | Recruiting | Las Vegas | Nevada | 89144-0518 | United States |
| Galderma Investigational Site 7055 | Recruiting | Portsmouth | New Hampshire | 03801-7156 | United States |
| Galderma Investigational Site - Site 7080 | Recruiting | Auburn | New York | 13021 | United States |
| Galderma Investigational Site # 7052 | Recruiting | East Syracuse | New York | 13057 | United States |
|
| Galderma Investigational Site - 8282 | Not yet recruiting | Mount Kisco | New York | 10549-3035 | United States |
| Galderma Investigational Site - 7051 | Recruiting | New York | New York | 10023 | United States |
| Galderma Investigational Site 7109 | Recruiting | New York | New York | 10028 | United States |
| Galderma Investigational Site 8279 | Not yet recruiting | New York | New York | 10075-0337 | United States |
| Galderma Investigational Site 7081 | Recruiting | Dayton | Ohio | 45414-2799 | United States |
| Galderma Investigational Site 7073 | Recruiting | Gresham | Oregon | 97030-2923 | United States |
| Galderma Investigational Site 8559 | Not yet recruiting | Philadelphia | Pennsylvania | 19103-4738 | United States |
| Galderma Investigational Site 7103 | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Galderma Investigational Site 7106 | Not yet recruiting | Bluffton | South Carolina | 29910 | United States |
| Galderma Investigational Site 7082 | Recruiting | Cedar Park | Texas | 78613-7875 | United States |
| Galderma Investigational Site 8238 | Recruiting | Dallas | Texas | 75230-5808 | United States |
| Galderma Investigational Site 7062 | Not yet recruiting | Edinburg | Texas | 78539-4660 | United States |
| Galderma Investigational Site 7088 | Recruiting | Grapevine | Texas | 76051 | United States |
| Galderma Investigational Site 7069 | Recruiting | Sugar Land | Texas | 77478-3842 | United States |
| Galderma Investigational Site 8618 | Not yet recruiting | Waco | Texas | 76710-4023 | United States |
| Galderma Investigational Site 7085 | Not yet recruiting | Bountiful | Utah | 84010-4801 | United States |
| Galderma Investigational Site 7079 | Not yet recruiting | Vienna | Virginia | 22182 | United States |
| Galderma Investigational Site 8725 | Recruiting | Morgantown | West Virginia | 26505-1873 | United States |
| Galderma Investigational Site 6374 | Recruiting | Karlsruhe | Baden-Wurttemberg | 76133 | Germany |
| Galderma Investigational Site 6412 | Recruiting | Langenau | Baden-Wurttemberg | 89129 | Germany |
| Galderma Investigational Site 6416 | Recruiting | Augsburg | Bavaria | 86179 | Germany |
| Galderma Investigational Site 6369 | Recruiting | Erlangen | Bavaria | 91054 | Germany |
| Galderma Investigational Site 6417 | Recruiting | Regensburg | Bavaria | 93053 | Germany |
| Galderma Investigational Site 6419 | Recruiting | Remscheid | North Rhine-Westphalia | 42897 | Germany |
| Galderma Investigational Site 6387 | Recruiting | Ahaus | 48683 | Germany |
| Galderma Investigational Site 6383 | Recruiting | Augsburg | 86150 | Germany |
| Galderma Investigational Site 6385 | Recruiting | Berlin | 10117 | Germany |
| Galderma Investigative Site 6172 | Recruiting | Berlin | 12203 | Germany |
|
| Galderma Investigational Site 6366 | Recruiting | Berlin | 13086 | Germany |
| Galderma Investigational Site 6398 | Recruiting | Bernau bei Berlin | 16321 | Germany |
| Galderma Investigational Site 6386 | Recruiting | Bielefeld | 33647 | Germany |
| Galderma Investigational Site 6066 | Recruiting | Buxtehude | 21614 | Germany |
|
| Galderma Investigational Site 6414 | Recruiting | Gladbeck | 45964 | Germany |
| Galderma Investigational Site 6418 | Recruiting | Großenhain | 1558 | Germany |
| Galderma Investigational Site 6370 | Recruiting | Haslach im Kinzigtal | 77716 | Germany |
| Galderma Investigational Site 6420 | Recruiting | Hersbruck | 91217 | Germany |
| Galderma Investigational Site 6384 | Recruiting | Koblenz | 56068 | Germany |
| Galderma Investigational Site 6013 | Recruiting | Lübeck | 23562 | Germany |
| Galderma Investigational Site 6373 | Recruiting | Mainz | 55128 | Germany |
| Galderma Investigational Site 6371 | Recruiting | Oberursel | 61440 | Germany |
| Galderma Investigational Site 6411 | Recruiting | Oranienburg | 16515 | Germany |
| Galderma Investigational Site 6390 | Recruiting | Pforzheim | 75172 | Germany |
| Galderma Investigational Site 6372 | Recruiting | Quedlinburg | 6484 | Germany |
| Galderma Investigational Site 5408 | Recruiting | London | Hampshire | NW3 2QG | United Kingdom |
| Galderma Investigational Site 6401 | Recruiting | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Galderma Investigational Site 6399 | Recruiting | Watford | Hertfordshire | WD18 0HB | United Kingdom |
| Galderma Investigational Site 6400 | Recruiting | Kings Lynn | Norfolk | PE30 4ET | United Kingdom |
| Galderma Investigational Site 5131 | Recruiting | Harrogate | North Yorkshire | HG2 7SX | United Kingdom |
| Galderma Investigational Site 6389 | Recruiting | Sheffield | South Yorkshire | S10 2TH | United Kingdom |
| Galderma Investigational Site 6395 | Recruiting | London | Surrey | SE5 9RS | United Kingdom |
| Galderma Investigational Site 6392 | Recruiting | Birmingham | West Midlands | B15 2GW | United Kingdom |
| Galderma Investigational Site 6404 | Recruiting | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| Galderma Investigational Site 6397 | Recruiting | York | Yorkshire | YO31 8HE | United Kingdom |
| Galderma Investigational Site 6375 | Recruiting | Bridgend | CF31 1RQ | United Kingdom |
| Galderma Investigational Site 6388 | Recruiting | Epsom | KT18 7EG | United Kingdom |
| Galderma Investigational Site 6394 | Recruiting | Harrow | HA3 7LT | United Kingdom |
| Galderma Investigational Site 6393 | Recruiting | Kingston upon Thames | KT2 7QB | United Kingdom |
| Galderma Investigational Site 6666 | Not yet recruiting | Kirkcaldy | KY2 5AH | United Kingdom |
| Galderma Investigational Site 6415 | Recruiting | Liverpool | L14 5AB | United Kingdom |
| Galderma Investigational Site 5210 | Recruiting | London | E11 1NR | United Kingdom |
| Galderma Investigational Site 6368 | Recruiting | London | SE1 9RT | United Kingdom |
| Galderma Investigational Site 6396 | Recruiting | Manchester | M23 2SY | United Kingdom |
| Galderma Investigational Site 6402 | Recruiting | Metropolitan Borough of Wirral | CH49 5PE | United Kingdom |
| Galderma Investigational Site 5431 | Recruiting | Redhill | RH1 5RH | United Kingdom |
| Galderma Investigational Site 6403 | Recruiting | Sandbach | CW11 | United Kingdom |
| Galderma Investigational Site 5989 | Recruiting | Swansea | SA2 8QA | United Kingdom |
| Galderma Investigational Site 5944 | Recruiting | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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