New shot could tame severe eczema in kids as young as 6 months
NCT ID NCT06311682
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This study tests whether a drug called tralokinumab, given as a shot along with steroid cream, can safely control moderate-to-severe eczema in children aged 6 months to under 12 years. About 195 participants will receive either the drug or a placebo for 16 weeks, then all will get the drug. The trial lasts up to 4 years and tracks skin clearance and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- tralokinumab (a biologic drug given as a shot) plus topical corticosteroids (steroid cream)
- What this could lead to
- If it works, this could provide a new treatment option for young children and infants with hard-to-control eczema, potentially reducing itch and skin flares.
- What could go wrong
- This is an early-phase trial in a small group, so results may not apply to all children. The drug requires regular injections and may cause side effects like injection reactions or infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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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Leo Pharma Investigational site
RECRUITINGBirmingham, Alabama, 35209, United States
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Leo Pharma Investigational site
RECRUITINGNorth Little Rock, Arkansas, 72117, United States
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Leo Pharma Investigational site
RECRUITINGPalo Alto, California, 94304, United States
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Leo Pharma Investigational site
RECRUITINGSacramento, California, 95816, United States
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Leo Pharma Investigational site
WITHDRAWNSan Diego, California, 92108, United States
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Leo Pharma Investigational site
RECRUITINGSan Diego, California, 92123, United States
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Leo Pharma Investigational site
RECRUITINGJacksonville, Florida, 32256, United States
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Leo Pharma Investigational site
RECRUITINGMiami, Florida, 33156, United States
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Leo Pharma Investigational site
RECRUITINGTampa, Florida, 33613, United States
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Leo Pharma Investigational site
RECRUITINGMacon, Georgia, 31217, United States
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Leo Pharma Investigational site
RECRUITINGWaterford, Michigan, 48328, United States
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Leo Pharma Investigational site
RECRUITINGTulsa, Oklahoma, 74136, United States
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Leo Pharma Investigational site
RECRUITINGPortland, Oregon, 97239, United States
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Leo Pharma Investigational site
RECRUITINGCharleston, South Carolina, 27420, United States
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Leo Pharma Investigational site
RECRUITINGNorfolk, Virginia, 23502, United States
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Leo Pharma Investigational site
WITHDRAWNBrussels, 1020, Belgium
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGGhent, 9000, Belgium
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Leo Pharma Investigational site
WITHDRAWNLeuven, 3000, Belgium
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Leo Pharma Investigational site
WITHDRAWNLiège, 4000, Belgium
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Leo Pharma Investigational site
RECRUITINGBurlington, L7L 6W6, Canada
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Leo Pharma Investigational site
WITHDRAWNCalgary, Calgary, Canada
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Leo Pharma Investigational site
RECRUITINGCalgary, T2J 7E1, Canada
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Leo Pharma Investigational site
RECRUITINGEdmonton, T5J 3S9, Canada
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Leo Pharma Investigational site
RECRUITINGEdmonton, T6G 1C3, Canada
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Leo Pharma Investigational site
RECRUITINGHamilton, L8S 1G5, Canada
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Leo Pharma Investigational site
RECRUITINGNiagara Falls, L2H 1H5, Canada
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Leo Pharma Investigational site
RECRUITINGSaskatoon, S7K 2C1, Canada
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Leo Pharma Investigational site
RECRUITINGWindsor, N8X2G1, Canada
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Leo Pharma Investigational site
RECRUITINGWinnipeg, R3M 3Z4, Canada
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGRijeka, 51000, Croatia
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGZagreb, 10000, Croatia
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Leo Pharma Investigational site
WITHDRAWNZagreb, 10000, Croatia
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Leo Pharma Investigational site
WITHDRAWNBuxtehude, 21614, Germany
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Leo Pharma Investigational site
WITHDRAWNDresden, 01307, Germany
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Leo Pharma Investigational site
WITHDRAWNMainz, 55131, Germany
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Leo Pharma Investigational site
WITHDRAWNOsnabrück, 49074, Germany
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGTübingen, 72076, Germany
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Leo Pharma Investigational site
WITHDRAWNWuppertal, 42283, Germany
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGCork, T12 DFK4, Ireland
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGCrumlin, D12N512, Ireland
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Leo Pharma Investigational site
WITHDRAWNAncona, 60126, Italy
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGBrescia, 25123, Italy
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGPadova, 35128, Italy
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGRoma, 00168, Italy
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGRome, 00165, Italy
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGUtrecht, 3584 CW, Netherlands
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGGdansk, 80-546, Poland
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGKrakow, 30-002, Poland
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGLodz, 90-436, Poland
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGOstrowiec Świętokrzyski, 27-400, Poland
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGRzeszów, 35-055, Poland
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGTarnów, 33-100, Poland
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGWarsaw, 02-953, Poland
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGWarsaw, 02-962, Poland
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGBrasov, 500091, Romania
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGIași, 700259, Romania
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGAnsan-si, 15355, South Korea
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGGwangju, 61453, South Korea
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGSeoul, 02447, South Korea
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGSeoul, 03080, South Korea
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGSeoul, 03722, South Korea
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGSeoul, 05030, South Korea
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Leo Pharma Investigational site
WITHDRAWNSeoul, 06273, South Korea
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Leo Pharma Investigational site
WITHDRAWNSeoul, 06591, South Korea
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGSeoul, 139-711, South Korea
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGAlicante, 03010, Spain
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Leo Pharma Investigational site
WITHDRAWNMadrid, 28046, Spain
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGValencia, 46014, Spain
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGLincoln, LN2 5QY, United Kingdom
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGLondon, WC1N 3JH, United Kingdom
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGSheffield, S10 2TH, United Kingdom
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Leo Pharma Investigational site
ACTIVE_NOT_RECRUITINGSouthampton, SO16 6YD, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new injection calm severe eczema when creams fall short?
- Can a new biologic calm severe eczema?
- Can a daily probiotic soothe colicky babies and calm eczema?
- Can a new injection match an existing eczema treatment?
- Can Real-World data unlock better skin disease care?
- Can a meditation app soothe teen eczema?