Phase
Condition
Allergy
Atopic Dermatitis
Hives (Urticaria)
Treatment
N/AClinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting > 3months or ≥ 2 flares within the previous 12 months.
- Screening and baseline IGA-CHE 3 or 4.
- Baseline CHE-related Itch NRS ≥ 4.
- Recent history (within the past 1 year of baseline) of inadequate response totreatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), ororal alitretinoin; or intolerance or contraindication to TCS or TCI or oralalitretinoin.
- Willingness to avoid pregnancy or fathering children based on the criteria below.
Exclusion
Exclusion Criteria:
- Known triggers for CHE (allergic or irritant, such as those identified by previouspatch tests) cannot be avoided during the course of this study.
- Participants who have an unstable course of AD (spontaneously improving or rapidlydeteriorating) as determined by the investigator in the 4 weeks prior to baseline.
- Participants with concurrent conditions and history of other diseases such as otheractive skin disease or infection on the hands; immunocompromised; chronic or acuteinfection requiring systemic treatments; active acute skin infection; otherconcomitant skin conditions that may interfere with study assessments or compromiseparticipant safety; other types of eczema; chronic asthma requiring high dose ofinhaled corticosteroids; current or history of hepatitis B or C virus infection.
- Any serious illness or medical, physical, or psychiatric condition(s) that, in theinvestigator's opinion, would interfere with full participation in the study,including administration of study drug and attending required study visits; pose asignificant risk to the participant; or interfere with interpretation of study data.
- Laboratory values outside of the protocol-defined criteria.
- Use of protocol-defined treatments within the indicated washout period beforebaseline.
- Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4weeks before baseline.
- Pregnant or lactating participants, or those considering pregnancy during the periodof their study participation.
- Further exclusion criteria apply.
Study Design
Connect with a study center
Medical Center Unimed Eood
Sevlievo, 05402
BulgariaSite Not Available
Dcc 'Alexandrovska', Eood
Sofia, 1431
BulgariaSite Not Available
Dcc Xxviii
Sofia, 01592
BulgariaSite Not Available
Mc 'Synexus - Sofia', Eood
Sofia, 01784
BulgariaSite Not Available
Medical Center Hera Eood
Sofia, 01510
BulgariaSite Not Available
MEDICAL CENTRE SYNEXUS SOFIA EOOD €� BRANCH STARA ZAGORA
Stara Zagora, 06000
BulgariaSite Not Available
Dr. Chih-Ho Hong Medical Inc.
Surrey, British Columbia V3R 6A7
CanadaSite Not Available
Simcomed Health Ltd
Barrie, Ontario L4M 1G7
CanadaSite Not Available
Xlr8 Medical Research
Windsor, Ontario N8W 1E6
CanadaSite Not Available
Fakultni Nemocnice U Sv. Anny V Brne
Brno, 656 91
CzechiaSite Not Available
Clintrial SRO
Praha 10, 100 00
CzechiaSite Not Available
Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.
Usti Nad Labem, 401 13
CzechiaSite Not Available
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, 10117
GermanySite Not Available
Universitaetsklinikum Frankfurt
Frankfurt, 60590
GermanySite Not Available
Derma-Study-Center Friedrichshafen Gmbh
Friedrichshafen, 88045
GermanySite Not Available
Dermatologikum Hamburg Gemeinschaftspraxis Gbr
Hamburg, 20354
GermanySite Not Available
Universitaetsklinikum Schleswig Holstein - Campus Luebeck
Luebeck, 23538
GermanySite Not Available
Gemeinschaftspraxis
Mahlow, 15381
GermanySite Not Available
Beldio Research Gmbh
Memmingen, 87700
GermanySite Not Available
Dermatologische Klinik Der Technischen Universitat Munchen
Muenchen, 80802
GermanySite Not Available
Dermatologische Klinik Der Technischen Universitat Munchen
Muenshen, 80802
GermanySite Not Available
Klifos - Klinische Forschung Osnabrück
Osnabruck, 49074
GermanySite Not Available
Synexus Affiliate - Bialystok - Clinicmed Daniluk Nowak Spolka Jawna
Bialystok, 15-879
PolandSite Not Available
Wojewodzki Szpital Zespolony W Elblagu
Elblag, 82-300
PolandSite Not Available
Centrum Badan Klinicznych Pi-House Sp. Z O.O.
Gdansk, 80-546
PolandSite Not Available
Centrum Medyczne Angelius Provita
Katowice, 40-611
PolandSite Not Available
Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
Kielce, 25-316
PolandSite Not Available
Etg Lublin
Lublin, 20-412
PolandSite Not Available
Laser Clinic S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki
Szczecin, 70-332
PolandSite Not Available
Etg Warszawa
Warsaw, 02-777
PolandSite Not Available
Royalderm
Warszawa, 02-962
PolandSite Not Available
Dermmedica Sp. Z O.O.
Wroclaw, 51-318
PolandSite Not Available
Clinica Dermomedic
Alcorcon, 28922
SpainSite Not Available
Hospital General Universitario de Alicante
Alicante, 03010
SpainSite Not Available
Clinica Dermomedic
Madrid, 28001
SpainSite Not Available
Hospital General Universitario Gregorio Marañon
Madrid, 28007
SpainSite Not Available
Hospital Universitario Quironsalud Madrid
Madrid, 28223
SpainSite Not Available
Hospital de Manises
Valencia, 46940
SpainSite Not Available
University of Alabama Hospital
Birmingham, Alabama 35249
United StatesSite Not Available
Marvel Clinical Research LLC
Huntington Beach, California 92647
United StatesSite Not Available
Advanced RX Clin Research
Westminster, California 92683
United StatesSite Not Available
Advanced Rx Clinical Research
Westminster, California 92683
United StatesSite Not Available
Forcare Clinical Research
Tampa, Florida 33613
United StatesSite Not Available
Midwest Allergy Sinus Asthma, Sc
Springfield, Illinois 62704
United StatesSite Not Available
The Indiana Clinical Trials Center Ictc
Plainfield, Indiana 46168
United StatesSite Not Available
Delricht Research
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Jubilee
Las Vegas, Nevada 89106
United StatesSite Not Available
Onsite Clinical Solutions, Llc Charlotte Central Office
Charlotte, North Carolina 28277
United StatesSite Not Available
Progressive Clinical Research
San Antonio, Texas 78213
United StatesSite Not Available
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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