Clinical Trials/NCT06436183

NCT06436183

Completed

Phase 2

A Phase 2a, Multicenter, Randomized, Double-blind, 16-week Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis

Apollo Therapeutics Ltd35 sites in 2 countries62 target enrollmentMay 1, 2024

ConditionsAtopic Dermatitis Atopic Dermatitis Dermatologic Disease Eczema Eczema Atopic Dermatitis Eczema, Atopic

InterventionsCamoteskimab Placebo

DrugsCamoteskimab Placebo

Overview

Phase: Phase 2
Intervention: Camoteskimab
Conditions: Atopic Dermatitis
Sponsor: Apollo Therapeutics Ltd
Enrollment: 62
Locations: 35
Primary Endpoint: Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 12
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2024

End Date

August 12, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Apollo Therapeutics Ltd

Responsible Party

Sponsor

Eligibility Criteria

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:
•Investigator global assessment (IGA) score of ≥ 3 (on a scale of 0 to 4, in which three is moderate and four is severe) at Baseline.
•AD involvement of ≥ 10% body surface area (BSA) at Baseline.
•EASI score of ≥ 12 at Baseline.
•Pruritus numerical rating scale (NRS) ≥ 4 at Baseline.
•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:

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:
•Dupilumab, tralokinumab, lebrikizumab within 8 weeks prior to Baseline.
•Systemic JAKi within 4 weeks prior to Baseline.
•TCS, TCI, topical phosphodiesterase-4 (PDE4) inhibitors, and topical JAKi within 7 days prior to enrollment (at Baseline) or more than five half-lives whichever is longer.
•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.

Arms & Interventions

Dose 1

Camoteskimab

Intervention: Camoteskimab

Dose 2

Camoteskimab

Intervention: Camoteskimab

Dose 2

Camoteskimab

Intervention: Placebo

Placebo

Dummy version of the study drug

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 12

Time Frame: 12 weeks

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

Proportion of participants achieving a 50, 75, 90 and 100% improvement from baseline in EASI (EASI-50, 75, 90 and 100) at Week 12(12 weeks)
Percent change from baseline in EASI score at Week 12(12 Weeks)
Change from baseline in EASI score at Week 12(12 weeks)
Proportion of participants with an IGA 0/1 and a decrease in IGA of ≥ 2 points at Week 12(12 weeks)
Change from baseline in peak pruritus score at Week 12(12 weeks)
Proportion of participants with an improvement of ≥ 4 or more points in peak pruritus weekly score at Week 12(12 weeks)
Change from baseline in POEM score at Week 12(12 weeks)
Change from baseline in DLQI score at Week 12(12 weeks)
Change from baseline in AD involvement by BSA at Week 12(12 weeks)
Change from baseline in SP-NRS at Week 12(12 weeks)
Change from baseline in PROMIS-SRI-SF-8a score at Week 12 reported outcomes(12 weeks)