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Atopic DermatitisPhase 3ADlongNCT05916365

Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic Dermatitis

A Phase 3 study testing Lebrikizumab in people with Atopic Dermatitis, run by Almirall, S.A. at 32 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of the study is to assess the long-term tolerability and effectiveness of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Lebrikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
32 sitesin 2 countries
Study dates
23 May 2023to 23 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants who completed treatment with lebrikizumab in ADjoin and their last participant assessment visit (Week 100) in that study.
  • 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.
  • 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.
  • 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.

Who cannot join

  • 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.
  • 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.
  • 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.).
  • 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.
  • 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.
  • 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.
Show all 9Show fewer
  • 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.
  • Any other conditions that, in the Investigator's opinion, might indicate the participant to be unsuitable for the trial.
  • Participant who is an employee or relative of an employee at the research site or Almirall.

Trial locations and contacts

32 sites in 2 countries.

32 sites in 2 countries

Poland20 sites

  • Investigator Site 30

    Gdansk, Woj. Pomorskie, 80-344

  • Investigator Site 13

    Gdansk, 80-462

  • Investigator Site 31

    Iwonicz-Zdrój, Podkarpackie Voivodeship, 38-440

  • Investigator Site 32

    Katowice, Silesian Voivodeship, 40-611

  • Investigator Site 14

    Katowice, 40-600

  • Investigator Site 15

    Kielce, 25-155

  • Investigator Site 26

    Krakow, Lesser Poland Voivodeship, 30-033

  • Investigator Site 25

    Krakow, Lesser Poland Voivodeship, 31-559

  • Investigator Site 24

    Lodz, Łódź Voivodeship, 90-436

  • Investigator Site 16

    Lublin, 20-081

  • Investigator Site 29

    Ossy, Silesian Voivodeship, 42-624

  • Investigator Site 17

    Poznan, 60-214

  • Investigator Site 18

    Rzeszów, 35-055

  • Investigator Site 19

    Szczecin, 71-434

  • Investigator Site 20

    Tarnów, 33-100

  • Investigator Site 28

    Warsaw, Masovian Voivodeship, 02-507

  • Investigator Site 27

    Warsaw, Masovian Voivodeship, 02-625

  • Investigator Site 21

    Warsaw, 01-142

  • Investigator Site 23

    Wroclaw, Lower Silesian Voivodeship, 51-503

  • Investigator Site 22

    Wroclaw, 50-566

Other trials in Poland

Germany12 sites

  • Investigator Site 1

    Augsburg, 86150

  • Investigator Site 10

    Bad Bentheim, Lower Saxony, 48455

  • Investigator Site 2

    Berlin, 10789

  • Investigator Site 3

    Berlin, 13055

  • Investigator Site 7

    Darmstadt, Hesse, 64283

  • Investigator Site 4

    Dresden, D-01307

  • Investigator Site 8

    Frankfurt am Main, Hesse, 60590

  • Investigator Site 5

    Hamburg, 20144

  • Investigator Site 6

    Hamburg, 20537

  • Investigator Site 12

    Leipzig, Saxony, 04103

  • Investigator Site 11

    Münster, North Rhine-Westphalia, 48149

  • Investigator Site 9

    Osnabrück, Lower Saxony, 49074

Other trials in Germany

About this study

Official title: A 2-year Open-label Extension Study to Assess the Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Dermatitis

The main purpose of the study is to assess the long-term tolerability and effectiveness of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD). Participants who complete the last assessment visit in ADjoin (Week 100) will be offered the opportunity to enroll in this extension study.

Being tested
Lebrikizumab
Keywords
Dermatitis
Medical subject headings
Dermatitis, Atopic, Dermatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LebrikizumabBiological

    Lebrikizumab solution for injection administered subcutaneously

Study groups in NCT05916365
Study groupRoleWhat they receive
LebrikizumabExperimentalAdult and adolescent participants (12 to less than [<] 18 years and weighing greater than or equal to [>=] 40 kilogram [kg]) with moderate-to-severe AD will receive lebrikizumab 250 milligrams (mg) subcutaneous (SC) injection via pre-filled syringe (PFS) for every fourth week (Q4W) for up to Week 104. If participants response is below EASI50 at any visit, lebrikizumab dosing frequency may be increased to every two weeks (Q2W) at any time during the course of the study; thereafter, lebrikizumab Q4W dosing may be resumed at the Investigator's discretion. Lebrikizumab will be administered up to Week 106 for participants who continue Q2W dosing, and these participants will undergo a safety follow-up assessment at Week 110.
Receives: Biological: Lebrikizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of the Participants who will Discontinue from Study Treatment due to Treatment-emergent Adverse Events (TEAEs)

    Measured: Baseline up to Week 110

Secondary outcomes (9)

  1. Percentage of Participants with Eczema Area and Severity Index (EASI) 50, EASI 75, and EASI 90 (>=50%, >=75%, and >=90%) Reduction in EASI Scores

    The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease. EASI 50 is defined as 50% reduction from baseline in the EASI score. EASI 75 is defined as 75% reduction from baseline in the EASI score. EASI 90 is defined as 90% reduction from baseline in the EASI score.

    Measured: Baseline up to Week 108

  2. Percentage Change from Baseline of Parent study in EASI Score

    The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease. Baseline (i.e., prior to first study drug administration) is defined for the parent studies, J2T-DM-KGAB (ADvocate-1), J2TDM-KGAC (ADvocate-2), J2T-DM-KGAD (ADhere), and J2T-DM-KGAE (ADore).

    Measured: Baseline up to Week 108

  3. Percentage of Participants with EASI Score <=7

    The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease. Baseline (i.e., prior to first study drug administration) is defined for the parent studies, J2T-DM-KGAB (ADvocate-1), J2TDM-KGAC (ADvocate-2), J2T-DM-KGAD (ADhere), and J2T-DM-KGAE (ADore).

    Measured: Baseline up to Week 108

  4. Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1

    The IGA is an instrument used to globally rate the severity of the participants AD. It is based on a 5-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe), and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

    Measured: Baseline up to Week 108

  5. Percentage of Participants Achieving Pruritus Numeric Rating Score (NRS) <= 4

    The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours, with 0 indicating "No itch," and 10 indicating "Worst itch imaginable.

    Measured: Baseline up to Week 108

  6. Percentage Change From Baseline of Parent Study in Body Surface Area (BSA) Involvement

    BSA affected by AD will be assessed for 4 separate body regions: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). BSA was calculated using the participant's palm using the 1% rule, 1 palm was equivalent to 1% with estimates of the number of palms it takes to cover the affected AD area. Maximum number of palms were 10 palms for head and neck (10%), 20 palms for upper extremities (20%), 30 palms for trunk, including axilla and groin (30%), 40 palms for lower extremities, including buttocks (40%). %BSA for a body region was calculated as = total number of palms in a body region * % surface area equivalent to 1 palm. Overall percent BSA of all 4 body regions ranges from 0% to 100 % with higher values represent greater severity of AD. Baseline (i.e., prior to first study drug administration) is defined for the parent studies, J2T-DM-KGAB (ADvocate-1), J2TDM-KGAC (ADvocate-2), J2T-DM-KGAD (ADhere), and J2T-DM-KGAE (ADore).

    Measured: Baseline to Week 108

  7. Proportion of Participants with Topical Corticosteroids (TCS)-free Days

    Proportion of participants TCS- free days will be reported.

    Measured: Baseline up to Week 108

  8. Percentage of Participants with DLQI/CDLQI Score <=5

    The DLQI is a 10-item validated questionnaire cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 ("not at all," "a little", "a lot," and "very much"), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI. Each question is scored from 0 to 3, giving a possible total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).

    Measured: Baseline up to Week 108

  9. Percentage of Participants Achieving at Least a 4-point Improvement from Baseline of Parent Study Dermatology Quality of Life Index/ Children's Dermatology Quality of Life Index (DLQI/CDLQI)

    The DLQI is a 10-item validated questionnaire cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 ("not at all," "a little", "a lot," and "very much"), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. The CDLQI is validated from adolescents younger than age of 16 years, which is based on a set of 10 questions different from those of the DLQI. Each question is scored from 0 to 3, giving a possible total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Baseline (i.e., prior to first study drug administration) is defined for the parent studies, J2T-DM-KGAB (ADvocate-1), J2TDM-KGAC (ADvocate-2), J2T-DM-KGAD (ADhere), and J2T-DM-KGAE (ADore).

    Measured: Baseline to Week 108

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start23 May 2023
  3. Primary completion23 Apr 2026
  4. Study completion23 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916365
Sponsor's protocol ID
M-17923-32
Other IDs
2022-502575-30-00
Acronym
ADlong
Status last verified
May 2026
First submitted
30 May 2023
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lebrikizumab in people with Atopic Dermatitis, run by Almirall, S.A. at 32 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Poland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of the Participants who will Discontinue from Study Treatment due to Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline up to Week 110). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05916365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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