Phase
Condition
Atopic Dermatitis
Dermatitis, Atopic
Molluscum Contagiosum (Pediatric)
Treatment
Camoteskimab
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must be 18-75 years of age inclusive, at the time of signing theinformed 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, inwhich 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 responseto treatment with topical medications, or for whom topical treatments are otherwisemedically inadvisable.
Contraceptive use should be consistent with local regulations regarding the methodsof contraception for those participating in clinical studies. Female participants:
Sexually active females of childbearing potential must agree to use two formsof accepted methods of highly effective forms of contraception during thecourse 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 killsperm); or
A vasectomized partner*. Male participants:
Sexually active male participants and males and who are partners of females ofchildbearing potential agree to use two forms of contraception as above and tonot donate sperm or try to conceive during the treatment period and for atleast 3 months after the last dose of study drug.
- Participant provides signed informed consent.
Exclusion
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 JAKiwithin 7 days prior to enrollment (at Baseline) or more than five half-liveswhichever is longer.
Participant has a current diagnosis of other active skin disease (e.g., psoriasis orlupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affectthe evaluation of AD or would interfere with the study assessments.
Participant has a severe comorbidity that may require systemic steroids therapy orother interventions or requires active frequent monitoring (e.g., unstable chronicasthma).
Any clinically significant abnormalities in rhythm, conduction or morphology of theresting electrocardiogram (ECG) and any clinically significant abnormalities in the 12- lead ECG as considered by the perfusion index that may interfere with theinterpretation of QTc interval changes.
Participant has AD involving ocular symptoms, or blepharitis, conjunctivitis, orkeratitis diagnosed within the last 60 days prior to the screening visit, requiringchronic ocular corticosteroid treatment.
Participant has severe or uncontrolled seasonal or allergic rhinitis, asthma or anyother non-AD disease as judged by the Investigator. Participants with seasonal orallergic rhinitis, asthma or any other non-AD disease requiring use of intranasal orinhaled corticosteroid that is stable and well-controlled are not excluded.
Active human immunodeficiency virus (HIV): confirmed positive anti-HIV antibody (HIVAb) test; Active hepatitis B virus (HBV): confirmed hepatitis B surface antigen (HBsAg) positive (+) or hepatitis B core antibody (HBc Ab) positive (+); Activehepatitis C virus (HCV): Confirmed hepatitis C antibody positive (+); evidence ofactive or latent TB
Diagnosed with a malignancy within 5 years of enrollment (suspected malignancyshould 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.
Has had previous exposure to anti-IL-18 therapy.
Treatment with any investigational agent, or any investigational device orprocedure, within 28 days (or 5 half- lives, whichever is greater) of screening.
Has any of the following laboratory findings
Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2.
Hemoglobin ≤8 g/dL.
Neutrophils ≤1,500/μL.
Platelets ≤75,000/μL.
Study Design
Study Description
Connect with a study center
Rejuvenation Dermatology Clinic Edmonton South
Edmonton, Alberta T6W 0J5
CanadaSite Not Available
Youthful Image
Edmonton, Alberta T5J 3S9
CanadaActive - Recruiting
Kingsway Clinical Research
Etobicoke, Ontario M8X 1Y9
CanadaActive - Recruiting
Ottawa Allergy Research Corporation
Ottawa, Ontario K1H 1E4
CanadaSite Not Available
Clinique Medicale Saint-Louis
Québec, Quebec G1W 4R4
CanadaActive - Recruiting
Clinique Dermatologique de Sherbrooke
Sherbrooke, Quebec J1G 1X9
CanadaActive - Recruiting
Medical Dermatology Specialists, PC/US Dermatology Partners
Phoenix, Arizona 85006
United StatesActive - Recruiting
California Dermatology & Clinical Research Institute
Encinitas, California 92024
United StatesActive - Recruiting
First OC Dermatology Research, Inc.
Fountain Valley, California 92708
United StatesActive - Recruiting
Center for Dermatology Clinical Research, Inc.
Fremont, California 94538
United StatesActive - Recruiting
California Allergy and Asthma Medical Group
Los Angeles, California 90025
United StatesActive - Recruiting
Keck School of Medicine of USC
Los Angeles, California 90095
United StatesSite Not Available
University of California Los Angeles Dermatology
Los Angeles, California 90095
United StatesActive - Recruiting
Amicis Research Center (Northridge)
Northridge, California 91324
United StatesActive - Recruiting
Cura Clinical Research
Oxnard, California 93030
United StatesActive - Recruiting
VASDHS - Veterans Affairs San Diego Medical Center
San Diego, California 92161
United StatesSite Not Available
Clinical Sciences Institute
Santa Monica, California 90404
United StatesActive - Recruiting
Renaissance Research and Medical Group
Cape Coral, Florida 33991
United StatesActive - Recruiting
Floridian Research Institute, Llc
Fort Myers, Florida 33901
United StatesSite Not Available
D&H National Research Centers, Inc.
Miami, Florida 33155
United StatesActive - Recruiting
Avita Clinical Research - Dermatology
Tampa, Florida 33613
United StatesActive - Recruiting
GCP Clinical Research
Tampa, Florida 33613
United StatesActive - Recruiting
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois 61761
United StatesActive - Recruiting
Dawes Fretzin Clinical Research
Indianapolis, Indiana 46250
United StatesActive - Recruiting
Skin Sciences, PLLC
Louisville, Kentucky 40217
United StatesActive - Recruiting
Owensboro Dermatology Associates
Owensboro, Kentucky 42303
United StatesActive - Recruiting
Revival Research Institute
Troy, Michigan 48084
United StatesActive - Recruiting
Somerset Skin Centre
Troy, Michigan 48084
United StatesActive - Recruiting
Michigan Dermatology Institute
Waterford, Michigan 28329
United StatesActive - Recruiting
Advanced Dermatology and Skin Cancer Center - Saint Joseph
Saint Joseph, Missouri 64506
United StatesActive - Recruiting
Skin Specialists PC
Omaha, Nebraska 68144
United StatesActive - Recruiting
M3 Wake Research, Inc.
Raleigh, North Carolina 27612
United StatesActive - Recruiting
ObjectiveHealth-The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
University Hospitals Case Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Central Sooner Research
Oklahoma City, Oklahoma 73071
United StatesActive - Recruiting
Unity Clinical Research - Dermatology
Oklahoma City, Oklahoma 73118
United StatesActive - Recruiting
Paddington Testing Co. Inc
Philadelphia, Pennsylvania 19103
United StatesActive - Recruiting
Rodgers Dermatology
Frisco, Texas 75034
United StatesActive - Recruiting
Center for Clinical Studies
Houston, Texas 77004
United StatesActive - Recruiting
Clinical Trial Network
Houston, Texas 77074
United StatesActive - Recruiting
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