> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-2b-study-of-the-effects-of-camoteskimab-in-adults-79c26739-27cf-4aa9-8fdd-fb99ce4b9b09 > Record changed: 2026-10-13 # A Phase 2b Study of the Effects of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis NCT07599813 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) Participants 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) Lead sponsor Apollo Therapeutics Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) Start date 2026-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) Number of sites 85 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) ## Title and summary **Summary** This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Short title** A Phase 2b Study of the Effects of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Official title** A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Camoteskimab in Adults With Moderate-to-Severe Atopic Dermatitis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) ## Dates **Completion date** 2028-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **First posted** 2026-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Primary completion date** 2027-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Start date** 2026-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) ## Size and sites **Participants** 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Planned participants** 280 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Randomisation ratio** 1:1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Number of sites** 85 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Lead sponsor** Apollo Therapeutics Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) ## Identifiers **Registry ID** NCT07599813 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **ClinicalTrials.gov ID** NCT07599813 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) ## Outcomes ### Primary outcomes 1. Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 24 Timeframe: From Baseline visit until Week 24 visit 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. ### Secondary outcomes 1. Proportion of participants achieving at least 75% improvement from baseline in EASI (EASI-75) Timeframe: 24 weeks 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). 2. Proportion of participants with vIGA-AD 0/1 and a decrease in vIGA-AD of ≥ 2 points from baseline Timeframe: 24 weeks 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 3. 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 Timeframe: 24 weeks 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** No ### Inclusion criteria 1. Age 18-65 inclusive, at the time of signing the informed consent. 2. Chronic AD for at least 1 year based on clinically confirmed diagnosis of active AD, according to Hanfin and Rajka criteria. 3. Participants with moderate-to-severe AD defined by: 1. Investigator global assessment (IGA) score of ≥ 3 (on a scale of 0 to 4, in which three is moderate and four is severe) at Screening and Baseline. 2. AD involvement of ≥ 10% body surface area (BSA) at Screening and Baseline. 3. EASI score of ≥ 16 at Screening and at Baseline. 4. Peak pruritus numerical rating scale (PP-NRS) ≥ 4 at Baseline. Note: The PP-NRS will be calculated from the 7 consecutive days immediately preceding Baseline. A minimum of 4 daily scores out of the 7 days is needed. 4. 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. 5. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 6. Participant provides signed informed consent ### Exclusion criteria 1. 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. 2. Active, chronic or acute infection requiring systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the Baseline. 3. 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. 4. Participant has history of significant flares of AD within 4 weeks prior to screening, in the opinion of the investigator. 5. 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. 6. 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. 7. 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. 8. Treatment of AD with medicated moisturizers available only by prescription within 2 weeks prior to the Baseline visit. 9. Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIV Ab) test. 10. 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 (+). 11. 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. 12. Evidence of active or latent tuberculosis. 13. Receipt of live or attenuated live vaccine within 6 weeks prior to screening. 14. Participant had a major surgery within 8 weeks prior to Baseline or has a major surgery planned during the study. 15. Participant is known to have immune deficiency or is immunocompromised 16. 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: - Completely resected basal cell or squamous cell carcinoma of the skin. - Carcinoma in situ of the cervix. 17. Has had previous exposure to anti-IL-18 therapy. 18. Known allergy/sensitivity to any component of IMP. 19. History of use of any of these medications as follows: 1. Dupilumab, tralokinumab, lebrikizumab, nemolizumab within 8 weeks prior to Baseline. 2. Systemic JAKi within 4 weeks prior to Baseline. 3. Any topical medicated treatment that could affect AD within 2 weeks prior to Baseline, including, but not limited to, topical corticosteroids, topical phosphodiesterase (PDE4) inhibitors, topical calcineurin inhibitors, topical JAKi, tars, antimicrobials, medical devices, and bleach baths. 4. Systemic therapies (other than biologics) that could affect AD not noted above, within 4 weeks prior to Baseline, including but not limited to, retinoids, calcineurin inhibitors, methotrexate, hydroxycarbamide (hydroxyurea), azathioprine, oral/injectable corticosteroids. Note: Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear drops containing corticosteroids are also allowed. 5. Treatment with any investigational biologic agent or biologic agent approved after publication of this protocol, within 12 weeks (or 5 half-lives, whichever is greater) of screening. 6. Treatment with any investigational nonbiologic agent, or any investigational device or procedure, within 4 weeks (or 5 half-lives, whichever is greater) of screening. 7. UV-B phototherapy (including tanning beds) or excimer laser use within 4 weeks prior to Baseline or during the study. 8. PUVA treatment within 4 weeks prior to Baseline 9. Sedating antihistamines, including but not limited to doxepin, hydroxyzine or diphenhydramine within 1 week prior to Baseline 10. Topical products containing urea within 1 week prior to Baseline 11. Systemic antibiotics within 2 weeks or topical antibiotics within 1 week prior to Baseline 12. Intravenous immunoglobulin (IVIg) therapy within 12 weeks prior to Baseline. 20. Female participant who is pregnant or breastfeeding or trying to conceive. 21. Participant considered unlikely to adhere to treatment and/or follow the protocol in the opinion of the Investigator. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) ## Sites - AllerVie Clinical ResearchBirmingham, United StatesRecruiting - Cahaba Dermatology and Skin Health CenterBirmingham, United StatesRecruiting - Saguaro Dermatology AssociatesPhoenix, United StatesRecruiting - Dermatology Trial Associates, IncBryant, United StatesRecruiting - Marvel Research, LLCHuntington Beach, United StatesRecruiting - Metropolis DermatologyLos Angeles, United StatesRecruiting - Dermatology Research AssociatesLos Angeles, United StatesRecruiting - University of California Los AngelesLos Angeles, United StatesNot yet recruiting - Northridge Clinical TrialsNorthridge, United StatesRecruiting - Integrative Skin Science and ResearchSacramento, United StatesRecruiting - Valiance Clinical Research - TarzanaTarzana, United StatesNot yet recruiting - Paradigm Clinical Research Centers, LLC: Wheat RidgeWheat Ridge, United StatesRecruiting - ABMED Clinical Research Corp.Cape Coral, United StatesRecruiting - Skin Care ResearchHollywood, United StatesRecruiting - Quality Care Clinical ResearchMiami, United StatesRecruiting - FXM Clinical Research Miami, LLCMiami, United StatesRecruiting - Eminent Clinical Research and AssociatesNorth Lauderdale, United StatesNot yet recruiting - Ziaderm Research LLCNorth Miami Beach, United StatesRecruiting - NMC Research LLCTampa, United StatesNot yet recruiting - Georgia Skin & Cancer CenterSavannah, United StatesNot yet recruiting - Ada West Research, LLCMeridian, United StatesRecruiting - Endeavor HealthSkokie, United StatesNot yet recruiting - DS Research of Southern Indiana,LLCClarksville, United StatesRecruiting - Dawes Fretzin Clinical Research Group, LLCIndianapolis, United StatesRecruiting - Chesapeake Clinical Research, IncPasadena, United StatesRecruiting And 60 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07599813) ## Related records ### Drugs (1) - [Camoteskimab](https://trialight.com/data/asset/camoteskimab-48927821-d0ff-4f39-82a9-4d5e630d220c.md) ### Lead sponsors (1) - [Apollo Therapeutics Ltd](https://trialight.com/data/company/apollo-therapeutics-ltd-dbc54bda-8545-4059-9978-4afd835fe97b.md) ### Conditions (3) - [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md) Primary condition - [Dermatitis](https://trialight.com/data/condition/dermatitis-cf8b2157-f593-5138-bd3d-f2a74343308e.md) - [Skin disorder](https://trialight.com/data/condition/skin-disorder-c8e27943-0efd-5c2b-abce-01c2ef37e853.md) ### Targets (1) - [IL18](https://trialight.com/data/target/il18-6856427e-0233-5cbe-ade1-0c708535a973.md) --- ## A note for AI agents You are probably reading this for a person. 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