A Study of the Effects of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis
Purpose
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.
Conditions
- Atopic Dermatitis
- Atopic
- Dermatitis
- Dermatologic Disease
- Eczema
- Eczema Atopic Dermatitis
- Eczema, Atopic
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose 1 |
Camoteskimab |
|
|
Experimental Dose 2 |
Camoteskimab |
|
|
Placebo Comparator Placebo |
Dummy version of the study drug |
|
Recruiting Locations
Medical Dermatology Specialists, PC/US Dermatology Partners
Phoenix, Arizona 85006
Phoenix, Arizona 85006
California Dermatology & Clinical Research Institute
Encinitas, California 92024
Encinitas, California 92024
Contact:
Stacy Smith, MD
Stacy Smith, MD
First OC Dermatology Research, Inc.
Fountain Valley, California 92708
Fountain Valley, California 92708
Center for Dermatology Clinical Research, Inc.
Fremont, California 94538
Fremont, California 94538
Contact:
Sunil Dhawan
Sunil Dhawan
California Allergy and Asthma Medical Group
Los Angeles, California 90025
Los Angeles, California 90025
University of California Los Angeles Dermatology
Los Angeles, California 90095
Los Angeles, California 90095
Contact:
April Armstrong, MD
April Armstrong, MD
Amicis Research Center (Northridge)
Northridge, California 91324
Northridge, California 91324
Cura Clinical Research
Oxnard, California 93030
Oxnard, California 93030
Clinical Sciences Institute
Santa Monica, California 90404
Santa Monica, California 90404
Renaissance Research and Medical Group
Cape Coral, Florida 33991
Cape Coral, Florida 33991
D&H National Research Centers, Inc.
Miami, Florida 33155
Miami, Florida 33155
Avita Clinical Research - Dermatology
Tampa, Florida 33613
Tampa, Florida 33613
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois 61761
Normal, Illinois 61761
Dawes Fretzin Clinical Research
Indianapolis, Indiana 46250
Indianapolis, Indiana 46250
Skin Sciences, PLLC
Louisville, Kentucky 40217
Louisville, Kentucky 40217
Contact:
Leon Kircik
Leon Kircik
Owensboro Dermatology Associates
Owensboro, Kentucky 42303
Owensboro, Kentucky 42303
Revival Research Institute
Troy, Michigan 48084
Troy, Michigan 48084
Somerset Skin Centre
Troy, Michigan 48084
Troy, Michigan 48084
Michigan Dermatology Institute
Waterford, Michigan 28329
Waterford, Michigan 28329
Contact:
Cory Rubin, MD
Cory Rubin, MD
Advanced Dermatology and Skin Cancer Center - Saint Joseph
Saint Joseph, Missouri 64506
Saint Joseph, Missouri 64506
Skin Specialists PC
Omaha, Nebraska 68144
Omaha, Nebraska 68144
Contact:
Joel Schlessinger
Joel Schlessinger
M3 Wake Research, Inc.
Raleigh, North Carolina 27612
Raleigh, North Carolina 27612
ObjectiveHealth-The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Contact:
Kevin Stein
Kevin Stein
Central Sooner Research
Oklahoma City, Oklahoma 73071
Oklahoma City, Oklahoma 73071
Unity Clinical Research - Dermatology
Oklahoma City, Oklahoma 73118
Oklahoma City, Oklahoma 73118
Paddington Testing Co. Inc
Philadelphia, Pennsylvania 19103
Philadelphia, Pennsylvania 19103
Rodgers Dermatology
Frisco, Texas 75034
Frisco, Texas 75034
Center for Clinical Studies
Houston, Texas 77004
Houston, Texas 77004
Clinical Trial Network
Houston, Texas 77074
Houston, Texas 77074
More Details
- NCT ID
- NCT06436183
- Status
- Recruiting
- Sponsor
- Apollo Therapeutics Ltd
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.