Phase
Condition
Molluscum Contagiosum (Pediatric)
Eczema (Atopic Dermatitis)
Dermatitis, Atopic
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
CanadaSite Not Available
Rejuvenation Dermatology Clinic Edmonton South
Edmonton 5946768, Alberta 5883102 T6W 0J5
CanadaSite Not Available
Youthful Image
Edmonton 5946768, Alberta 5883102 T5J 3S9
CanadaSite Not Available
Kingsway Clinical Research
Etobicoke, Ontario M8X 1Y9
CanadaSite Not Available
Ottawa Allergy Research Corporation
Ottawa, Ontario K1H 1E4
CanadaSite Not Available
Kingsway Clinical Research
Etobicoke 5950268, Ontario 6093943 M8X 1Y9
CanadaSite Not Available
Clinique Medicale Saint-Louis
Québec, Quebec G1W 4R4
CanadaSite Not Available
Clinique Dermatologique de Sherbrooke
Sherbrooke, Quebec J1G 1X9
CanadaSite Not Available
Clinique Medicale Saint-Louis
Québec 6325494, Quebec 6115047 G1W 4R4
CanadaSite Not Available
Clinique Dermatologique de Sherbrooke
Sherbrooke 6146143, Quebec 6115047 J1G 1X9
CanadaSite Not Available
Medical Dermatology Specialists, PC/US Dermatology Partners
Phoenix, Arizona 85006
United StatesSite Not Available
Medical Dermatology Specialists, PC/US Dermatology Partners
Phoenix 5308655, Arizona 5551752 85006
United StatesSite Not Available
California Dermatology & Clinical Research Institute
Encinitas, California 92024
United StatesSite Not Available
First OC Dermatology Research, Inc.
Fountain Valley, California 92708
United StatesSite Not Available
Center for Dermatology Clinical Research, Inc.
Fremont, California 94538
United StatesSite Not Available
California Allergy and Asthma Medical Group
Los Angeles, California 90025
United StatesSite Not Available
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 StatesSite Not Available
Amicis Research Center (Northridge)
Northridge, California 91324
United StatesSite Not Available
Cura Clinical Research
Oxnard, California 93030
United StatesSite Not Available
VASDHS - Veterans Affairs San Diego Medical Center
San Diego, California 92161
United StatesSite Not Available
Clinical Sciences Institute
Santa Monica, California 90404
United StatesSite Not Available
California Dermatology & Clinical Research Institute
Encinitas 5346646, California 5332921 92024
United StatesSite Not Available
First OC Dermatology Research, Inc.
Fountain Valley 5350207, California 5332921 92708
United StatesSite Not Available
Center for Dermatology Clinical Research, Inc.
Fremont 5350734, California 5332921 94538
United StatesSite Not Available
California Allergy and Asthma Medical Group
Los Angeles 5368361, California 5332921 90025
United StatesSite Not Available
University of California Los Angeles Dermatology
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
Amicis Research Center (Northridge)
Northridge 5377985, California 5332921 91324
United StatesSite Not Available
Cura Clinical Research
Oxnard 5380184, California 5332921 93030
United StatesSite Not Available
VASDHS - Veterans Affairs San Diego Medical Center
San Diego 5391811, California 5332921 92161
United StatesSite Not Available
Clinical Sciences Institute
Santa Monica 5393212, California 5332921 90404
United StatesSite Not Available
Renaissance Research and Medical Group
Cape Coral, Florida 33991
United StatesSite Not Available
Floridian Research Institute, Llc
Fort Myers, Florida 33901
United StatesSite Not Available
D&H National Research Centers, Inc.
Miami, Florida 33155
United StatesSite Not Available
Avita Clinical Research - Dermatology
Tampa, Florida 33613
United StatesSite Not Available
GCP Clinical Research
Tampa, Florida 33613
United StatesActive - Recruiting
Renaissance Research and Medical Group
Cape Coral 4149962, Florida 4155751 33991
United StatesSite Not Available
D&H National Research Centers, Inc.
Miami 4164138, Florida 4155751 33155
United StatesSite Not Available
Avita Clinical Research - Dermatology
Tampa 4174757, Florida 4155751 33613
United StatesSite Not Available
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois 61761
United StatesSite Not Available
Sneeze, Wheeze & Itch Associates, LLC
Normal 4903780, Illinois 4896861 61761
United StatesSite Not Available
Dawes Fretzin Clinical Research
Indianapolis, Indiana 46250
United StatesSite Not Available
Dawes Fretzin Clinical Research
Indianapolis 4259418, Indiana 4921868 46250
United StatesSite Not Available
Skin Sciences, Pllc
Louisville, Kentucky 40217
United StatesSite Not Available
Owensboro Dermatology Associates
Owensboro, Kentucky 42303
United StatesSite Not Available
Skin Sciences, PLLC
Louisville 4299276, Kentucky 6254925 40217
United StatesSite Not Available
Owensboro Dermatology Associates
Owensboro 4303436, Kentucky 6254925 42303
United StatesSite Not Available
Revival Research Institute
Troy, Michigan 48084
United StatesSite Not Available
Somerset Skin Centre
Troy, Michigan 48084
United StatesSite Not Available
Michigan Dermatology Institute
Waterford, Michigan 28329
United StatesSite Not Available
Revival Research Institute
Troy 5012639, Michigan 5001836 48084
United StatesSite Not Available
Somerset Skin Centre
Troy 5012639, Michigan 5001836 48084
United StatesSite Not Available
Michigan Dermatology Institute
Waterford 5014130, Michigan 5001836 28329
United StatesSite Not Available
Advanced Dermatology and Skin Cancer Center - Saint Joseph
Saint Joseph, Missouri 64506
United StatesSite Not Available
Advanced Dermatology and Skin Cancer Center - Saint Joseph
Saint Joseph 4407010, Missouri 4398678 64506
United StatesSite Not Available
Skin Specialists PC
Omaha, Nebraska 68144
United StatesSite Not Available
Skin Specialists PC
Omaha 5074472, Nebraska 5073708 68144
United StatesSite Not Available
M3 Wake Research, Inc.
Raleigh, North Carolina 27612
United StatesSite Not Available
ObjectiveHealth-The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina 27103
United StatesSite Not Available
M3 Wake Research, Inc.
Raleigh 4487042, North Carolina 4482348 27612
United StatesSite Not Available
ObjectiveHealth-The Skin Surgery Center for Clinical Research
Winston-Salem 4499612, North Carolina 4482348 27103
United StatesSite Not Available
University Hospitals Case Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Central Sooner Research
Oklahoma City, Oklahoma 73071
United StatesSite Not Available
Unity Clinical Research - Dermatology
Oklahoma City, Oklahoma 73118
United StatesSite Not Available
Central Sooner Research
Oklahoma City 4544349, Oklahoma 4544379 73071
United StatesSite Not Available
Unity Clinical Research - Dermatology
Oklahoma City 4544349, Oklahoma 4544379 73118
United StatesSite Not Available
Paddington Testing Co. Inc
Philadelphia, Pennsylvania 19103
United StatesSite Not Available
Paddington Testing Co. Inc
Philadelphia 4560349, Pennsylvania 6254927 19103
United StatesSite Not Available
Rodgers Dermatology
Frisco, Texas 75034
United StatesSite Not Available
Center for Clinical Studies
Houston, Texas 77004
United StatesSite Not Available
Clinical Trial Network
Houston, Texas 77074
United StatesSite Not Available
Rodgers Dermatology
Frisco 4692559, Texas 4736286 75034
United StatesSite Not Available
Center for Clinical Studies
Houston 4699066, Texas 4736286 77004
United StatesSite Not Available
Clinical Trial Network
Houston 4699066, Texas 4736286 77074
United StatesSite Not Available

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