Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension to evaluate the efficacy and safety of camoteskimab in adults with moderate to severe AD.
This study contains two parts: Parts 1 and Part 2.
Part 1 (Blinded Period):
Eligible patients will be randomized in a 1:1:1 ratio to receive either camoteskimab dose 1, camoteskimab dose 2 or placebo.
Part 2 (Extension Period):
In part 2, all participants will receive camoteskimab.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | Camoteskimab |
|
| Dose 2 | Experimental | Camoteskimab |
|
| Placebo | Placebo Comparator | Dummy version of the study drug |
|
| 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 12 | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in EASI score at Week 12 | To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD). | 12 Weeks |
| Change from baseline in EASI score at Week 12 |
Not provided
Inclusion Criteria:
Participants must be 18-75 years of age inclusive, at the time of signing the informed consent.
Chronic AD for at least 1 year.
Participants with moderate to severe AD defined by:
Participants who are candidates for systemic therapy, defined as inadequate response to treatment with topical medications, or for whom topical treatments are otherwise medically inadvisable.
Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Female participants:
Male participants:
Participant provides signed informed consent.
Exclusion Criteria:
Participant has history of use of more than two (2) prior systemic therapies for AD (e.g.
biologics or JAKi) and who used any of these medications as follows:
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.
Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma).
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 perfusion index that may interfere with the interpretation of QTc interval changes.
Participant has AD involving ocular symptoms, or blepharitis, conjunctivitis, or keratitis diagnosed within the last 60 days prior to the screening visit, requiring chronic ocular corticosteroid treatment.
Participant has severe or uncontrolled seasonal or allergic rhinitis, asthma or any other non-AD disease as judged by the Investigator. Participants with seasonal or allergic rhinitis, asthma or any other non-AD disease requiring use of intranasal or inhaled corticosteroid that is stable and well-controlled are not excluded.
Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test; Active hepatitis B virus (HBV): confirmed hepatitis B surface antigen (HBs Ag) positive (+) or hepatitis B core antibody (HBc Ab) positive (+); Active hepatitis C virus (HCV): Confirmed hepatitis C antibody positive (+); evidence of active or latent TB
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.
Treatment with any investigational agent, or any investigational device or procedure, within 28 days (or 5 half- lives, whichever is greater) of screening.
Has any of the following laboratory findings
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists, PC/US Dermatology Partners | Phoenix | Arizona | 85006 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Inactive substance |
|
To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD). |
| 12 weeks |
| Proportion of participants achieving a 50, 75, 90 and 100% improvement from baseline in EASI (EASI-50, 75, 90 and 100) at Week 12 | To further assess the efficacy of camoteskimab in participants with AD via the Eczema Area and Severity Index (EASI) which measures the severity of clinical signs in atopic dermatitis (AD). | 12 weeks |
| Proportion of participants with an IGA 0/1 and a decrease in IGA of ≥ 2 points at Week 12 | To further assess the efficacy of camoteskimab in participants with AD via Investigator's Global Assessment Scale (IGA), which provides a global clinical assessment of AD severity. | 12 weeks |
| Change from baseline in peak pruritus score at Week 12 | To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity. | 12 weeks |
| Proportion of participants with an improvement of ≥ 4 or more points in peak pruritus weekly score at Week 12 | To further assess the efficacy of camoteskimab in participants with AD via the Pruritus Numerical Rating Scale, which assesses itch severity. | 12 weeks |
| Change from baseline in POEM score at Week 12 | To further assess the efficacy of camoteskimab in participants with AD via the Patient-Oriented Eczema Measure (POEM) which assesses disease systems. | 12 weeks |
| Change from baseline in DLQI score at Week 12 | To further assess the efficacy of camoteskimab in participants with AD via the Dermatology Life Quality Index (DLQI) which assesses quality of life. | 12 weeks |
| Change from baseline in AD involvement by BSA at Week 12 | To further assess the efficacy of camoteskimab in participants with AD via Body Surface Area (BSA) which assesses the percentage of the total skin affected by AD. | 12 weeks |
| Change from baseline in SP-NRS at Week 12 | To further assess the efficacy of camoteskimab in participants with AD via the Skin Pain Numerical Rating Scale (SP-NRS) which assesses skin pain. | 12 weeks |
| Change from baseline in PROMIS-SRI-SF-8a score at Week 12 reported outcomes | To further assess the efficacy of camoteskimab in participants with AD via Patient Reported Outcomes Measurement Information System (PROMIS) which measures patient-reported health status for physical, mental, and social well-being. | 12 weeks |
| California Dermatology & Clinical Research Institute |
| Encinitas |
| California |
| 92024 |
| United States |
| First OC Dermatology Research, Inc. | Fountain Valley | California | 92708 | United States |
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| California Allergy and Asthma Medical Group | Los Angeles | California | 90025 | United States |
| University of California Los Angeles Dermatology | Los Angeles | California | 90095 | United States |
| Amicis Research Center (Northridge) | Northridge | California | 91324 | United States |
| Cura Clinical Research | Oxnard | California | 93030 | United States |
| VASDHS - Veterans Affairs San Diego Medical Center | San Diego | California | 92161 | United States |
| Clinical Sciences Institute | Santa Monica | California | 90404 | United States |
| Renaissance Research and Medical Group | Cape Coral | Florida | 33991 | United States |
| D&H National Research Centers, Inc. | Miami | Florida | 33155 | United States |
| Avita Clinical Research - Dermatology | Tampa | Florida | 33613 | United States |
| Sneeze, Wheeze & Itch Associates, LLC | Normal | Illinois | 61761 | United States |
| Dawes Fretzin Clinical Research | Indianapolis | Indiana | 46250 | United States |
| Skin Sciences, PLLC | Louisville | Kentucky | 40217 | United States |
| Owensboro Dermatology Associates | Owensboro | Kentucky | 42303 | United States |
| Revival Research Institute | Troy | Michigan | 48084 | United States |
| Somerset Skin Centre | Troy | Michigan | 48084 | United States |
| Michigan Dermatology Institute | Waterford | Michigan | 28329 | United States |
| Advanced Dermatology and Skin Cancer Center - Saint Joseph | Saint Joseph | Missouri | 64506 | United States |
| Skin Specialists PC | Omaha | Nebraska | 68144 | United States |
| M3 Wake Research, Inc. | Raleigh | North Carolina | 27612 | United States |
| ObjectiveHealth-The Skin Surgery Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Central Sooner Research | Oklahoma City | Oklahoma | 73071 | United States |
| Unity Clinical Research - Dermatology | Oklahoma City | Oklahoma | 73118 | United States |
| Paddington Testing Co. Inc | Philadelphia | Pennsylvania | 19103 | United States |
| Rodgers Dermatology | Frisco | Texas | 75034 | United States |
| Center for Clinical Studies | Houston | Texas | 77004 | United States |
| Clinical Trial Network | Houston | Texas | 77074 | United States |
| Youthful Image | Edmonton | Alberta | T5J 3S9 | Canada |
| Rejuvenation Dermatology Clinic Edmonton South | Edmonton | Alberta | T6W 0J5 | Canada |
| Kingsway Clinical Research | Etobicoke | Ontario | M8X 1Y9 | Canada |
| Clinique Medicale Saint-Louis | Québec | Quebec | G1W 4R4 | Canada |
| Clinique Dermatologique de Sherbrooke | Sherbrooke | Quebec | J1G 1X9 | Canada |
| 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 |
Not provided
Not provided