Clinical trial NCT06436183: A Study of the Effects of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Atopic Dermatitis
Atopic
Dermatitis
Dermatologic Disease
Eczema
Eczema Atopic Dermatitis
Eczema, Atopic
Lead sponsor: Apollo Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Participants must be 18-75 years of age inclusive, at the time of signing the informed consent.
2. Chronic AD for at least 1 year.
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 Baseline.
   2. AD involvement of ≥ 10% body surface area (BSA) at Baseline.
   3. EASI score of ≥ 12 at Baseline.
   4. Pruritus numerical rating scale (NRS) ≥ 4 at Baseline.
4. 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.
5. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

   Female participants:
   * Sexually active females of childbearing potential must agree to use two forms of accepted methods of highly effective forms of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes:
   * IUD plus one barrier method.
   * Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method.
   * 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or
   * A vasectomized partner\*.

   Male participants:
   * Sexually active male participants and males and who are partners of females of childbearing potential agree to use two forms of contraception as above and to not donate sperm or try to conceive during the treatment period and for at least 3 months after the last dose of study drug.
6. Participant provides signed informed consent.

Exclusion Criteria:

1. 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:
   1. Dupilumab, tralokinumab, lebrikizumab within 8 weeks prior to Baseline.
   2. Systemic JAKi within 4 weeks prior to Baseline.
   3. 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.
2. 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.
3. Participant has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma).
4. 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.
5. 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.
6. 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.
7. 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
8. 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 call or squamous cell carcinoma of the skin.
   * Carcinoma in situ of the cervix.
9. Has had previous exposure to anti-IL-18 therapy.
10. Treatment with any investigational agent, or any investigational device or procedure, within 28 days (or 5 half- lives, whichever is greater) of screening.
11. Has any of the following laboratory findings

    1. Glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2.
    2. Hemoglobin ≤8 g/dL.
    3. Neutrophils ≤1,500/μL.
    4. Platelets ≤75,000/μL.

Primary outcomes:
measure: Percentage change from baseline in Eczema Area and Severity Index (EASI) between camoteskimab and placebo at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent change from baseline in EASI score at Week 12
timeFrame: 12 Weeks
measure: Change from baseline in EASI score at Week 12
timeFrame: 12 weeks
measure: Proportion of participants achieving a 50, 75, 90 and 100% improvement from baseline in EASI (EASI-50, 75, 90 and 100) at Week 12
timeFrame: 12 weeks
measure: Proportion of participants with an IGA 0/1 and a decrease in IGA of ≥ 2 points at Week 12
timeFrame: 12 weeks
measure: Change from baseline in peak pruritus score at Week 12
timeFrame: 12 weeks
measure: Proportion of participants with an improvement of ≥ 4 or more points in peak pruritus weekly score at Week 12
timeFrame: 12 weeks
measure: Change from baseline in POEM score at Week 12
timeFrame: 12 weeks
measure: Change from baseline in DLQI score at Week 12
timeFrame: 12 weeks
measure: Change from baseline in AD involvement by BSA at Week 12
timeFrame: 12 weeks
measure: Change from baseline in SP-NRS at Week 12
timeFrame: 12 weeks
measure: Change from baseline in PROMIS-SRI-SF-8a score at Week 12 reported outcomes
timeFrame: 12 weeks
measure: Change from baseline in DLQI score at Week 16
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Dermatology Specialists, PC/US Dermatology Partners
state: Arizona
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology Research, Inc.
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles Dermatology
state: California
city: Northridge
country: United States
facility: Amicis Research Center (Northridge)
state: California
city: Oxnard
country: United States
facility: Cura Clinical Research
state: California
city: San Diego
country: United States
facility: VASDHS - Veterans Affairs San Diego Medical Center
state: California
city: Santa Monica
country: United States
facility: Clinical Sciences Institute
state: California
city: Cape Coral
country: United States
facility: Renaissance Research and Medical Group
state: Florida
city: Miami
country: United States
facility: D&H National Research Centers, Inc.
state: Florida
city: Tampa
country: United States
facility: Avita Clinical Research - Dermatology
state: Florida
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates, LLC
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research
state: Indiana
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Dermatology Associates
state: Kentucky
city: Troy
country: United States
facility: Revival Research Institute
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Waterford
country: United States
facility: Michigan Dermatology Institute
state: Michigan
city: Saint Joseph
country: United States
facility: Advanced Dermatology and Skin Cancer Center - Saint Joseph
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists PC
state: Nebraska
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: ObjectiveHealth-The Skin Surgery Center for Clinical Research
state: North Carolina
city: Oklahoma City
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Unity Clinical Research - Dermatology
state: Oklahoma
city: Philadelphia
country: United States
facility: Paddington Testing Co. Inc
state: Pennsylvania
city: Frisco
country: United States
facility: Rodgers Dermatology
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Edmonton
country: Canada
facility: Youthful Image
state: Alberta
city: Edmonton
country: Canada
facility: Rejuvenation Dermatology Clinic Edmonton South
state: Alberta
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: Québec
country: Canada
facility: Clinique Medicale Saint-Louis
state: Quebec
city: Sherbrooke
country: Canada
facility: Clinique Dermatologique de Sherbrooke
state: Quebec
Study officials:
References: