New eczema drug shows promise in 2-Year extension trial

NCT ID NCT05916365

Disease control Sponsor: Almirall, S.A. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety and effectiveness of lebrikizumab for adults and teens with moderate-to-severe atopic dermatitis (eczema). Participants who completed a previous year-long study could join this 2-year extension. The main goal was to see how many people stopped treatment due to side effects, and researchers also tracked how well the drug controlled eczema symptoms.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

174 people

The number who actually took part.

Started

May 2023

Finished

Apr 2026

Lead sponsor

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

12 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants who completed treatment with lebrikizumab in ADjoin and their last participant assessment visit (Week 100) in that study. 2. For WOCBP: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 4 weeks after the last dose of lebrikizumab. NOTE: A WOCBP is defined as a postmenarcheal female, who has not reached a postmenopausal state (\>=12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus). NOTE: The following are highly effective contraceptive methods: combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, bilateral tubal ligation, vasectomized partner, or sexual abstinence. In the context of this protocol, sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception. 3. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol and provide written informed consent/assent in accordance with institutional and regulatory guidelines. 4. Capable of giving signed informed consent/assent as described in which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: 1. Participants who, having participated in ADjoin, had their last lebrikizumab dose administered in a window longer than 8 weeks prior to the Baseline Visit in the current study. 2. Participants who, during their participation in the parent trial or ADjoin, developed an SAE or a severe AE that was deemed related to lebrikizumab, which in the opinion of the Investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. 3. Conditions in the parent study or ADjoin consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to lebrikizumab or led to Investigator or Sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.). 4. Treatment with a live (attenuated) vaccine from the time of last lebrikizumab dose in ADjoin prior to enrolment in the current study or planned during the study. 5. Use of a prohibited medication from the time of last lebrikizumab dose in ADjoin prior to enrolment in the current study or planned during the study. 6. Pregnant or breastfeeding women, and women planning to become pregnant or breastfeed during the study and for at least 4 weeks after the last dose of lebrikizumab. 7. Severe concomitant illness(es) that in the Investigator's judgment would adversely affect the participant's participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient because of his/her participation in this clinical trial, may make participant's participation unreliable, or may interfere with study assessments. 8. Any other conditions that, in the Investigator's opinion, might indicate the participant to be unsuitable for the trial. 9. Participant who is an employee or relative of an employee at the research site or Almirall.

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Conditions

The condition(s) this trial relates to.

atopic eczema dermatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

Investigator Site 1

Augsburg, 86150, Germany
Investigator Site 10

Bad Bentheim, Lower Saxony, 48455, Germany
Investigator Site 11

Münster, North Rhine-Westphalia, 48149, Germany
Investigator Site 12

Leipzig, Saxony, 04103, Germany
Investigator Site 13

Gdansk, 80-462, Poland
Investigator Site 14

Katowice, 40-600, Poland
Investigator Site 15

Kielce, 25-155, Poland
Investigator Site 16

Lublin, 20-081, Poland
Investigator Site 17

Poznan, 60-214, Poland
Investigator Site 18

Rzeszów, 35-055, Poland
Investigator Site 19

Szczecin, 71-434, Poland
Investigator Site 2

Berlin, 10789, Germany
Investigator Site 20

Tarnów, 33-100, Poland
Investigator Site 21

Warsaw, 01-142, Poland
Investigator Site 22

Wroclaw, 50-566, Poland
Investigator Site 23

Wroclaw, Lower Silesian Voivodeship, 51-503, Poland
Investigator Site 24

Lodz, Łódź Voivodeship, 90-436, Poland
Investigator Site 25

Krakow, Lesser Poland Voivodeship, 31-559, Poland
Investigator Site 26

Krakow, Lesser Poland Voivodeship, 30-033, Poland
Investigator Site 27

Warsaw, Masovian Voivodeship, 02-625, Poland
Investigator Site 28

Warsaw, Masovian Voivodeship, 02-507, Poland
Investigator Site 29

Ossy, Silesian Voivodeship, 42-624, Poland
Investigator Site 3

Berlin, 13055, Germany
Investigator Site 30

Gdansk, Woj. Pomorskie, 80-344, Poland
Investigator Site 31

Iwonicz-Zdrój, Podkarpackie Voivodeship, 38-440, Poland
Investigator Site 32

Katowice, Silesian Voivodeship, 40-611, Poland
Investigator Site 4

Dresden, D-01307, Germany
Investigator Site 5

Hamburg, 20144, Germany
Investigator Site 6

Hamburg, 20537, Germany
Investigator Site 7

Darmstadt, Hesse, 64283, Germany
Investigator Site 8

Frankfurt am Main, Hesse, 60590, Germany
Investigator Site 9

Osnabrück, Lower Saxony, 49074, Germany

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