Eczema patients learn to Self-Inject in new study
NCT ID NCT06224192
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether teenagers and adults with moderate-to-severe eczema (atopic dermatitis) could successfully give themselves injections of the drug rocatinlimab at home using special devices. The main goal was to see how many full doses were self-administered correctly up to 16 weeks. The study involved 151 participants and was completed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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151 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Mar 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 12 at Day 1. * Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months. * History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]). * Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3 at screening and pre-randomization. * Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening and pre-randomization. * ≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization. Exclusion Criteria: * Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization. * Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization: 1. Systemic corticosteroids 2. Non-biologic, non-targeted systemic immunosuppressants 3. Oral or Topical Janus kinase inhibitors * Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization: 1. Topical phosphodiesterase 4 (PDE4) inhibitors 2. Other topical immunosuppressive agents (not including TCS/TCI) 3. Combination topical agents containing any of the above components
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ajou University Hospital
Suwon-si, Gyeonggi-do, 16499, South Korea
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Allergy Research Canada Incorporated
Niagara Falls, Ontario, L2H 1H5, Canada
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Alliance Clinical Trials
Waterloo, Ontario, N2J 1C4, Canada
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Anchor Medical Research
Miami, Florida, 33176, United States
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Apex Clinical Research Center LLC
Mayfield Heights, Ohio, 44124, United States
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Asan Medical Center
Seoul, 05505, South Korea
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Bexley Dermatology Research
Bexley, Ohio, 43209, United States
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Cumberland Skin Center
Hermitage, Tennessee, 37076, United States
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DermEdge Research Incorporated
Mississauga, Ontario, L4Y 4C5, Canada
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Dermatology Ottawa Research Centre
Ottawa, Ontario, K2C 3N2, Canada
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Dermatology Research Associates
Los Angeles, California, 90045, United States
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Dermatology and Ophthalmology Kume Clinic
Sakai-shi, Osaka, 593-8324, Japan
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Dermatology and Skin Cancer Center Leawood
Leawood, Kansas, 66211, United States
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Direct Helpers Research Center
Hialeah, Florida, 33012, United States
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Ekihigashi Dermatology Allergy Clinic
Fukuoka, Fukuoka, 812-0013, Japan
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Essential Medical Research LLC
Tulsa, Oklahoma, 74137, United States
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Excel Clinical Research
Las Vegas, Nevada, 89109, United States
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FACET Dermatology
Toronto, Ontario, M4E 1R7, Canada
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Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180, Japan
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Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
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Hamilton Research, LLC
Alpharetta, Georgia, 30022, United States
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Havana Research Institute Inc
Pasadena, California, 91105, United States
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Health Concepts
Rapid City, South Dakota, 57702, United States
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Integrative Skin Science and Research
Sacramento, California, 95815, United States
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Interior Dermatology Centre
Kelowna, British Columbia, V1W 4V5, Canada
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Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
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Kern Research Inc
Bakersfield, California, 93301, United States
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Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355, South Korea
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Kyung Hee University Hospital at Gangdong
Seoul, 05278, South Korea
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LEADER Research
Hamilton, Ontario, L8L 3C3, Canada
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Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030, United States
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Long Beach Research Institute
Long Beach, California, 90805, United States
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Lynderm Research Inc
Markham, Ontario, L3P 1X3, Canada
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Matsuo Clinic
Fukuoka, Fukuoka, 819-0373, Japan
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Mita Dermatology Clinic
Minato-ku, Tokyo, 108-0014, Japan
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North Bay Dermatology Centre
North Bay, Ontario, P1B 3Z7, Canada
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Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
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Skin Cancer and Dermatology Institute
Reno, Nevada, 89509, United States
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Skinsense Medical Research
Saskatoon, Saskatchewan, S7K 2C1, Canada
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Sms Clinical Research Limited Liability Company
Mesquite, Texas, 75149, United States
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Suizenji Dermatology Clinic
Kumamoto, Kumamoto, 862-0950, Japan
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Texas Dermatology Research Center
Plano, Texas, 75025, United States
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The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
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The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
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Treasure Valley Medical Research
Boise, Idaho, 83706, United States
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Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, 23502, United States
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XLR8 Medical Research, Incorporated
Windsor, Ontario, N8T 1E6, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Skin scans may predict who responds to dupilumab for eczema
- Can a daily liquid medicine calm severe eczema in toddlers and preschoolers?
- Scientists probe whether lebrikizumab rewires diseased skin at the molecular level
- Can a Lab-Made antibody calm severe eczema?
- Is your nose fueling infected eczema and scabies sores?
- Can an eczema drug reshape the Skin's microbial community?