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This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study.
This study contains two parts: Part 1 and Part 2.
Part 1 (24-Week Placebo-controlled Period):
Eligible patients will be randomized in a 1:1:1:1 ratio to receive either camoteskimab dose 1, camoteskimab dose 2, camoteskimab dose 3 or placebo.
Part 2 (Extension Period):
In part 2, all participants will receive camoteskimab.
This study will enroll both treatment-naive participants and those with an inadequate response to previous biologic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | Camoteskimab administered subcutaneously |
|
| Dose 2 | Experimental | Camoteskimab administered subcutaneously |
|
| Dose 3 | Experimental | Camoteskimab administered subcutaneously |
|
| Placebo | Placebo Comparator | Dummy version of the study drug administered subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camoteskimab | Drug | Drug Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 24 | An EASI score is a tool used to measure the extent (area) and severity of atopic eczema. The EASI utilizes area assessments that rate the four involved regions on a 0% to 100% scale for each region. The scores are added up for each of the four body regions (head, arms, trunk, and legs). For each of these components, the individual scores are added together to calculate the EASI score, which ranges from 0 to 72. The higher the EASI score, the more severe the AD. | From Baseline visit until Week 24 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving at least 75% improvement from baseline in EASI (EASI-75) | To further assess the efficacy of camoteskimab in participants with moderate-to-severe AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD). | 24 weeks |
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Inclusion Criteria:
Age 18-65 inclusive, at the time of signing the informed consent.
Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria.
Participants with moderate-to-severe AD defined by:
Participants who are candidates for systemic therapy, defined as history of inadequate response to topical AD treatments applied for at least 28 days, or for the maximum duration recommended by the product prescribing information, or for treatment with topical AD treatments is medically inadvisable due to important side effects or safety risks.
Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Participant provides signed informed consent
Exclusion Criteria:
History or other evidence of severe illness or any other conditions such as psychiatric illness, severe depression or previous history of suicidal attempt in past 10 years that would render the participant, in the opinion of the Investigator, unsuitable for the study.
Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline.
Participant has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of AD or would interfere with the study assessments based on the Investigator's judgement.
Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator.
Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma) based on investigator judgement.
Any clinically significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically significant abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes.
Participant has severe and uncontrolled seasonal or allergic rhinitis, severe and uncontrolled asthma or any other severe and uncontrolled atopic disease as judged by the Investigator.
Treatment of AD with medicated moisturizers available only by prescription within 2 weeks prior to the Baseline visit.
Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test.
Active hepatitis B virus (HBV): hepatitis B surface antigen (HBs Ag) positive (+) or hepatitis B core antibody (HBc Ab) positive (+) confirmed by HBV PCR positive (+).
Active hepatitis C virus (HCV): If hepatitis C antibody positive (+), confirmed by HCV RNA test. Note: a participant with documented proof of cure from HCV may be enrolled.
Evidence of active or latent tuberculosis.
Receipt of live or attenuated live vaccine within 6 weeks prior to screening.
Participant had a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study.
Participant is known to have immune deficiency or is immunocompromised
Diagnosed with a malignancy within 5 years of enrollment (suspected malignancy should be ruled out by blood or tissue biopsy, as applicable) with the exception of:
Has had previous exposure to anti-IL-18 therapy.
Known allergy/sensitivity to any component of IMP.
History of use of any of these medications as follows:
Female participant who is pregnant or breastfeeding or trying to conceive.
Participant considered unlikely to adhere to treatment and/or follow the protocol in the opinion of the Investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AllerVie Clinical Research | Not yet recruiting | Birmingham | Alabama | 35209 | United States | |
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| Placebo | Drug | Inactive substance |
|
| Proportion of participants with vIGA-AD 0/1 and a decrease in vIGA-AD of ≥ 2 points from baseline |
To further assess the efficacy of camoteskimab in participants with moderate-to-severe AD via Validated Investigator's Global Assessment Scale, which provides a global clinical assessment of AD severity |
| 24 weeks |
| Proportion of participants with an improvement of ≥ 4 or more points from baseline in peak pruritus NRS (PP-NRS) weekly average of the daily scores | To further assess the efficacy of camoteskimab in participants with moderate-to-severe AD via the Peak Pruritus Numerical Rating Scale, which assesses itch severity. | 24 weeks |
| Cahaba Dermatology and Skin Health Center |
| Not yet recruiting |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Saguaro Dermatology Associates | Not yet recruiting | Phoenix | Arizona | 85018 | United States |
| Dermatology Trial Associates, Inc | Not yet recruiting | Bryant | Arkansas | 72022 | United States |
| Marvel Research, LLC | Not yet recruiting | Huntington Beach | California | 92648 | United States |
| Metropolis Dermatology | Not yet recruiting | Los Angeles | California | 90025 | United States |
| Dermatology Research Associates | Not yet recruiting | Los Angeles | California | 90048 | United States |
| University of California Los Angeles | Not yet recruiting | Los Angeles | California | 90095 | United States |
| Northridge Clinical Trials | Recruiting | Northridge | California | 91325 | United States |
|
| Integrative Skin Science and Research | Recruiting | Sacramento | California | 95815 | United States |
|
| Valiance Clinical Research - Tarzana | Not yet recruiting | Tarzana | California | 91356 | United States |
| Paradigm Clinical Research Centers, LLC: Wheat Ridge | Not yet recruiting | Wheat Ridge | Colorado | 80033 | United States |
| ABMED Clinical Research Corp. | Not yet recruiting | Cape Coral | Florida | 33904 | United States |
| International Dermatology Research, INC | Not yet recruiting | Hollywood | Florida | 33021 | United States |
| Quality Care Clinical Research | Not yet recruiting | Miami | Florida | 33101 | United States |
| FXM Clinical Research Miami, LLC | Not yet recruiting | Miami | Florida | 33155 | United States |
| Eminent Clinical Research and Associates | Not yet recruiting | North Lauderdale | Florida | 33068 | United States |
| Ziaderm Research LLC | Not yet recruiting | North Miami Beach | Florida | 33162 | United States |
| NMC Research LLC | Not yet recruiting | Tampa | Florida | 33614 | United States |
| Elligo - Georgia Skin & Cancer Clinic (Sidney P. Smith, MD, PC) | Not yet recruiting | Savannah | Georgia | 31406 | United States |
| Ada West Research, LLC | Recruiting | Meridian | Idaho | 83646 | United States |
|
| Endeavor Health | Not yet recruiting | Skokie | Illinois | 60077 | United States |
| DS Research of Southern Indiana,LLC | Recruiting | Clarksville | Indiana | 47129 | United States |
|
| Dawes Fretzin Clinical Research Group, LLC | Not yet recruiting | Columbus | Indiana | 47201 | United States |
| Chesapeake Clinical Research, Inc | Not yet recruiting | Pasadena | Maryland | 21122 | United States |
| Skin Cancer and Dermatology Institute | Recruiting | Reno | Nevada | 89509 | United States |
|
| Trail Horizon | Not yet recruiting | Clifton | New Jersey | 07013 | United States |
| Sadick Research Group, LLC | Recruiting | New York | New York | 10021 | United States |
|
| Red River Research Partners, LLC | Not yet recruiting | Fargo | North Dakota | 58103 | United States |
| ClinOhio Research Services | Recruiting | Columbus | Ohio | 43213 | United States |
|
| Best Skin Research, LLC | Recruiting | Camp Hill | Pennsylvania | 17011 | United States |
|
| UPMC Department of Dermatology | Not yet recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Progressive Clinical Research, PA | Recruiting | San Antonio | Texas | 78213 | United States |
|
| Medical Center Medconsult Burgas EOOD | Not yet recruiting | Burgas | Bulgaria |
| Medical Center Kazanlak EOOD | Not yet recruiting | Kazanlak | Bulgaria |
| Medical Center Medconsult Pleven-Lovech Branch | Not yet recruiting | Lovech | Bulgaria |
| Medical Center Medconsult Pleven OOD | Not yet recruiting | Pleven | Bulgaria |
| Medical Centre Pratia Clinic EOOD | Not yet recruiting | Varna | Bulgaria |
| Beacon Dermatology | Not yet recruiting | Calgary | Alberta | Canada |
| Laser Rejuvenation Clinics Edmonton D.T. Inc. | Not yet recruiting | Calgary | Alberta | Canada |
| Laser Rejuvenation Clinics Edmonton D.T. Inc. | Not yet recruiting | Edmonton | Alberta | Canada |
| Rejuvenation Dermatology Clinic Edmonton South | Not yet recruiting | Edmonton | Alberta | Canada |
| DermEdge Research | Not yet recruiting | Mississauga | Ontario | Canada |
| FACET Dermatology | Not yet recruiting | Toronto | Ontario | Canada |
| North York Research Inc. | Not yet recruiting | Toronto | Ontario | Canada |
| Centre de Recherche Saint-Louis (Sherbrooke) | Recruiting | Sherbrooke | Quebec | Canada |
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| Saskatoon Dermatology Centre | Recruiting | Saskatoon | Saskatchewan | Canada |
|
| CCR Ostrava s.r.o. | Not yet recruiting | Ostrava | Czechia |
| Pratia Pardubice a.s. | Not yet recruiting | Pardubice | Czechia |
| Clintrial s.r.o. | Not yet recruiting | Prague | Czechia |
| Fakultni Nemocnice Kralovske Vinohrady | Not yet recruiting | Prague | Czechia |
| Praglandia s.r.o. | Not yet recruiting | Prague | Czechia |
| Pratia Prague | Not yet recruiting | Prague | Czechia |
| Fachklinik Bad Bentheim | Not yet recruiting | Bad Bentheim | Germany |
| University Hospital Dresden | Not yet recruiting | Dresden | Germany |
| Universitatsklinikum Frankfurt Klinik fur Dermatologie, Venerologie und Allergologie | Not yet recruiting | Frankfurt | Germany |
| Dermatologikum Hamburg GmbH | Not yet recruiting | Hamburg | Germany |
| University of Luebeck | Not yet recruiting | Lübeck | Germany |
| University Hospital of Muenster | Not yet recruiting | Münster | Germany |
| Hautarztpraxis Dr. Hoffmann | Not yet recruiting | Witten | Germany |
| Trial Pharma Kft. | Not yet recruiting | Békéscsaba | Hungary |
| Dept. Dermatology, Venereology and Dermatooncology, Semmelweis University | Not yet recruiting | Budapest | Hungary |
| Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center) | Not yet recruiting | Debrecen | Hungary |
| Pecsi Tudomanyegyetem | Not yet recruiting | Pécs | Hungary |
| Komplex Labor Kft | Not yet recruiting | Szeged | Hungary |
| University of Szeged | Not yet recruiting | Szeged | Hungary |
| NZOZ Centrum Medyczne KERmed | Not yet recruiting | Bydgoszcz | Poland |
| OptiTrial | Not yet recruiting | Chojnice | Poland |
| Dermedea Clinic | Not yet recruiting | Gdansk | Poland |
| CM Pratia Katowice | Not yet recruiting | Katowice | Poland |
| Provita Sp. z o. o. | Not yet recruiting | Katowice | Poland |
| Klinika Zdybski - Dermedic (Kielce) | Not yet recruiting | Kielce | Poland |
| Clinical Best Solution Sp. z o.o. | Not yet recruiting | Lublin | Poland |
| NZOZ Hipokrates | Not yet recruiting | Piotrkow Trybunalski | Poland |
| Twoja Przychodnia Poznanskie Centrum Medyczne Sp. | Not yet recruiting | Poznan | Poland |
| Laser Clinic S.C. Andrzej Krolicki, Tomasz Kochanowski | Not yet recruiting | Szczecin | Poland |
| Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. | Not yet recruiting | Szczecin | Poland |
| Klinika Ambroziak Dermatologia | Not yet recruiting | Warsaw | Poland |
| Medicus Clinic | Not yet recruiting | Wroclaw | Poland |
| Softskin Medical Center Dr Elzbieta Wojtowicz-Prus | Not yet recruiting | Wroclaw | Poland |
| Hospital General Universitario Dr. Balmis | Not yet recruiting | Alicante | Spain |
| Hospital Universitari Germans Trias i Pujol | Not yet recruiting | Badalona | Spain |
| Hospital Universitario La Paz | Not yet recruiting | La Paz | Spain |
| Complejo Hospitalario Universitario de Santiago de Compostela | Not yet recruiting | Santiago de Compostela | Spain |
| Hospital Universitario Miguel Servet | Not yet recruiting | Zaragoza | Spain |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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