Trials
Search / Trial NCT06436183

A Study of the Effects of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis

Launched by APOLLO THERAPEUTICS LTD · May 22, 2024

Trial Information

Current as of February 12, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called camoteskimab for adults with moderate to severe atopic dermatitis, which is a type of eczema that causes itchy and inflamed skin. The goal is to understand how effective and safe this treatment is for individuals who have struggled with this condition for at least a year and have not found relief with other treatments. The trial is open to adults aged 18 to 75 who have significant symptoms, such as a moderate to severe score on a standard assessment and a considerable area of their body affected.

Participants in this trial can expect to be randomly assigned to receive either camoteskimab or a placebo (a treatment that does not contain the active drug) for a set period, followed by an extension phase where everyone will receive camoteskimab. Throughout the study, they will have regular check-ups to monitor their symptoms and overall health. It’s important to note that participants need to meet specific criteria, such as not having used certain other eczema treatments recently, and must agree to use effective birth control if they are sexually active. This trial is currently recruiting participants who meet these guidelines, and it offers an opportunity for those with challenging eczema to explore a potential new treatment option.

Gender

ALL

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.

About Apollo Therapeutics Ltd

Apollo Therapeutics Ltd. is a pioneering biopharmaceutical company dedicated to advancing innovative therapies for patients with unmet medical needs. Leveraging a unique partnership model that integrates academic research and industry expertise, Apollo focuses on the discovery and development of cutting-edge therapeutics across various disease areas. With a commitment to translating scientific breakthroughs into transformative treatments, the company aims to enhance patient outcomes through its robust pipeline of drug candidates and collaborative initiatives. Apollo Therapeutics is at the forefront of bridging the gap between laboratory research and clinical application, striving to make a meaningful impact in the field of medicine.

Locations

Troy, Michigan, United States

Normal, Illinois, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Omaha, Nebraska, United States

Los Angeles, California, United States

Houston, Texas, United States

Fremont, California, United States

Owensboro, Kentucky, United States

Encinitas, California, United States

Etobicoke, Ontario, Canada

Louisville, Kentucky, United States

Indianapolis, Indiana, United States

Raleigh, North Carolina, United States

Frisco, Texas, United States

Cape Coral, Florida, United States

Oklahoma City, Oklahoma, United States

Miami, Florida, United States

Fountain Valley, California, United States

Ottawa, Ontario, Canada

Sherbrooke, Quebec, Canada

Troy, Michigan, United States

Phoenix, Arizona, United States

Los Angeles, California, United States

San Diego, California, United States

Fort Myers, Florida, United States

Tampa, Florida, United States

Saint Joseph, Missouri, United States

Edmonton, Alberta, Canada

Edmonton, Alberta, Canada

Québec, Quebec, Canada

Oxnard, California, United States

Winston Salem, North Carolina, United States

Northridge, California, United States

Waterford, Michigan, United States

Oklahoma City, Oklahoma, United States

Santa Monica, California, United States

Tampa, Florida, United States

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0