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Dermatitis, AtopicPhase 3ADhope 2NCT06526182

A Study of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

A Phase 3 study testing Lebrikizumab in people with Dermatitis, Atopic and Eczema, run by Almirall, S.A. at 4 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The main purpose of this study is to evaluate the effectiveness of 24 weeks of lebrikizumab in improving disease severity, signs, and symptoms in adults and adolescents with moderate-to-severe AD in Part 1 and to describe how similar is the current maintenance dosing regimen of lebrikizumab 250 mg every 4 weeks (Q4W)… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Dermatitis, Atopic, Eczema
What is being tested?
Lebrikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
520 participants
Where
4 sitesSpain
Study dates
3 Jul 2024to 25 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • Part 1:
  • Adults and adolescents (aged greater than or equal to [>=] 12 to less than [<] 18 at the time of informed consent form [ICF]/informed assent form [IAF] signature and weighing 40 >= kilograms [kg]) who are candidates for systemic AD therapy.
  • Chronic AD (according to Hanifin and Rajka Criteria (Hanifin 1980)) that has been present for >= 1 year before the screening visit.
  • EASI score >= 12 at the Day 1/Baseline Visit.
  • IGA score >= 3 (moderate) (scale of 0 [clear] to 4 [severe]) at the Day 1/Baseline visit.
  • >= 10% BSA of AD involvement at the Day 1/Baseline visit.
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  • History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
  • Completed electronic diary (eDiary) entries for pruritus and sleep-loss for a minimum of 4 of 7 days before Day 1/Baseline.
  • Willing and able to comply with all clinic visits and study-related procedures and questionnaires.
  • For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or to use a highly effective contraceptive method during the treatment period and for at least 4 weeks or 1 menstrual period after the last dose of lebrikizumab.
  • Participant must provide signed ICF. Adolescent participants must also provide separate informed assent to enroll in the study and sign and date either a separate IAF or the ICF signed by the parent/legal guardian (as appropriate based on local regulations and requirements).
  • Part 2:
  • Demonstrate clinical response to treatment at Week 24 of Part 1, defined as achieving EASI 75 or IGA 0/1 without the use of high-potency TCS within the prior 4 weeks or systemic corticosteroids at any time post baseline.

Who cannot join

  • Prior treatment at any time with tralokinumab, lebrikizumab, or an oral JAK inhibitor.
  • Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication.
  • History of anaphylaxis as defined by the Sampson criteria (Sampson 2006).
  • Uncontrolled chronic disease that might require bursts of oral corticosteroids, eg, comorbid severe uncontrolled asthma (defined by an Asthma Control Questionnaire-5 score >= 1.5 or a history of >= 2 asthma exacerbations within the last 12 months requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalisation for >24 hours).
  • Occurrence of the following types of infection within 3 months before or during screening or development of these infections before Day 1/Baseline:
  • Serious (requiring hospitalisation, and/or IV or equivalent oral antibiotic treatment, as per the Investigator's opinion);
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  • Opportunistic (as defined by Winthrop et al. (Winthrop 2015))
  • Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer);
  • Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis).
  • Known current or chronic infection with any hepatitis virus.
  • Known liver cirrhosis and/or chronic hepatitis of any aetiology.
  • Known active endoparasitic infection or at high risk of these infections.
  • Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgement.
  • History of human immunodeficiency virus (HIV) infection or known positive HIV serology.
  • Any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit that would jeopardise the participants participation in the study, per the Investigator's judgement.
  • Presence of skin comorbidities that may interfere with study assessments.
  • History of malignancy, including mycosis fungoides, within 5 years before the Screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
  • Severe concomitant illness(es) that in the Investigator's judgement would adversely affect the 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 participant because of his/her participation in this clinical trial, may make participation unreliable, or may interfere with study assessments.
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
  • Any known hypersensitivity or allergic response to lebrikizumab or any component of the investigational medicinal product (IMP).
  • For the scratch sensor substudy only: a history of allergic response to skin adhesives, active skin or systemic infection, active AD on the back of the hand, or a pre-existing sleep disorder, including insomnia, obstructive sleep apnea, or restless leg syndrome, or currently taking prescription sleep medications.

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • Hospital General Universitario Dr. Balmis

    Alicante

  • Hospital del Mar - Parc de Salut Mar

    Barcelona

  • Hospital Universitario Clínico San Cecilio

    Granada

  • Consorci Hospital General Universitari de València

    Valencia

Other trials in Spain

About this study

Official title: A Phase 3, 2-Part, Open-Label and Double-Blind, Randomised Study to Evaluate the Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis

The main purpose of this study is to evaluate the effectiveness of 24 weeks of lebrikizumab in improving disease severity, signs, and symptoms in adults and adolescents with moderate-to-severe AD in Part 1 and to describe how similar is the current maintenance dosing regimen of lebrikizumab 250 mg every 4 weeks (Q4W) to the new proposed; lebrikizumab 500 mg every 12 weeks (Q12W), in terms of efficacy, safety, PK, ADA and blood biomarkers.

Read the detailed description

This study consists of two parts. Part 1 is a single-arm, open-label design, where participants will receive lebrikizumab subcutaneous (SC) injections up to Week 24. Part 2 is a randomized, double-blind design, in which participants who achieve clinical response in Part 1 will continue receiving lebrikizumab treatment across two periods: a Run-in period and a Double-blind period. Participants who do not maintain at least a 50% reduction in Eczema Area and Severity Index (EASI) from baseline during Double-Blind Period will enter an Escape Arm.

Being tested
Lebrikizumab, Placebo
Keywords
Dermatitis, Skin Diseases, Skin Diseases, Eczematous, Moderate-to-severe atopic dermatitis
Medical subject headings
Dermatitis, Atopic, Eczema, Dermatitis, Skin Diseases, Skin Diseases, Eczematous

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.

  • PlaceboOther

    Lebrikizumab Matching placebo solution for injection administered subcutaneously.

Study groups in NCT06526182
Study groupRoleWhat they receive
Part 1: Open label (Lebrikizumab)ExperimentalParticipants with moderate-to-severe AD will receive loading doses of lebrikizumab 500 mg SC injection (2 injections) at Day 1 and Week 2 followed by 250 mg (1 injection) every 2 weeks (Q2W) after Week 4 to Week 16 followed by 250 mg (1 injection) every 4 weeks (Q4W) after Week 16 to Week 24.
Receives: Biological: Lebrikizumab
Part 2: Open label Run-In Period (Lebrikizumab)ExperimentalParticipants who respond to lebrikizumab treatment at Week 24 of Part 1 will continue treatment in Part 2, which includes an 8-week open-label Run-In Period to confirm sustained clinical response. During this period, they will receive lebrikizumab 250 mg SC injection (1 injection) Q4W starting from the Week 24 visit of Part 1.
Receives: Biological: Lebrikizumab
Part 2: Double-Blind (Lebrikizumab)ExperimentalAt the end of the Run-In Period, participants who demonstrate sustained clinical response will continue treatment in the double-blind period. They will either receive lebrikizumab 250 mg SC injection (1 injection) Q4W or switch to lebrikizumab 500 mg SC injection (2 injections) Q12W for 36 weeks.
Receives: Biological: Lebrikizumab
Part 2: Double-Blind (Placebo)Placebo comparatorAt the end of the Run-In Period, participants who demonstrate sustained clinical response will continue treatment in the double-blind period. They will either receive lebrikizumab matching placebo 250 mg SC injection (1 injection) Q4W or switch to lebrikizumab matching placebo 500 mg SC injection (2 injections) Q12W for 36 weeks.
Receives: Other: Placebo
Part 2: Open label Escape Arm (Lebrikizumab)ExperimentalParticipants who do not maintain at least a 50% reduction in EASI from baseline (EASI 50) during Double-Blind Period will enter an Escape Arm, in which participants are treated with open label lebrikizumab 250 mg SC injection Q4W. Study drug treatment will be discontinued in participants entering the Escape Arm who do not maintain an EASI 50 response.
Receives: Biological: Lebrikizumab

What is being measured

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

  1. Part 1: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score Less than or Equal to (<=) 7 at Week 24

    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. The severity of erythema, induration/papulation, excoriation, and lichenification will be assessed by the Investigator or trained designee on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. In addition, the extent of AD involvement in each of the 4 body areas will be assessed as a percentage by body area of head/neck, trunk, upper limbs, and lower limbs, and converted to a score of 0 (0%), 1 (0 to 9%), 2 (10 to 29%), 3 (30 to 49%), 4 (50 to 69%), 5 (70 to 89%) and 6 (90 to 100%).

    Measured: At Week 24

  2. Part 2: Percentage of Participants Achieving EASI 75 at Week 36

    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 75 is defined as 75% reduction from baseline in the EASI score.

    Measured: At Week 36

  3. Part 2: Percentage of Participants with an IGA Score of 0 or 1 and a Reduction >=2 Points

    The IGA is an instrument used to globally rate the severity of the participant's 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 (minimal, palpable induration and significant induration).

    Measured: From Baseline (Part 1) up to Week 36

Secondary outcomes (25)

  1. Part 1: Time to Achieve an 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.

    Measured: Baseline up to Week 24

  2. Part 1: Percentage of Participants Achieving EASI <=5, and EASI <=3 at Week 24

    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. The severity of erythema, induration/papulation, excoriation, and lichenification will be assessed by the Investigator or trained designee on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. In addition, the extent of AD involvement in each of the 4 body areas will be assessed as a percentage by body area of head/neck, trunk, upper limbs, and lower limbs, and converted to a score of 0 (0%), 1 (0 to 9%), 2 (10 to 29%), 3 (30 to 49%), 4 (50 to 69%), 5 (70 to 89%) and 6 (90 to 100%).

    Measured: At Week 24

  3. Part 1: Percentage of Participants Achieving EASI 75 and EASI 90 at Week 24

    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 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: At Week 24

  4. Part 1: Percentage of Participants with an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction Greater Than or Equal to (>=2) Points at Week 24

    The IGA is an instrument used to globally rate the severity of the participant's 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 (minimal, palpable induration and significant induration).

    Measured: At Week 24

  5. Part 1: Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) 75, and SCORAD 90 at Week 24

    The SCORAD is a validated measure of the extent and severity of atopic dermatitis lesions, along with subjective symptoms. The score ranges from 0 to 103, with higher values indicating a more extensive and/or severe condition. SCORAD 75 is defined as 75% reduction in SCORAD from baseline. SCORAD 90 is defined as 90% reduction in SCORAD from baseline.

    Measured: At Week 24

  6. Part 1: Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS) at Week 24

    mTLSS combines an evaluation of hand eczema lesions severity including 6 key signs (erythema, desquamation, lichenification/hyperkeratosis, vesiculae, oedema, fissures) and the intensity of pruritus and pain. The seven features of AD of the hand (erythema, scaling, lichenification/hyperkeratosis, vesiculation, oedema, fissures, pruritus/pain) form the composite scale of mTLSS' strength and each one of them scores from 0 (mild) to 3 (severe). The scores is summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 21 (more serious disease).

    Measured: At Week 24

  7. Part 1: Percentage of Participants with Pruritus Numerical Rating Scale (NRS) >=4 at Baseline Achieving >=4-Point Improvement in Pruritus NRS

    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 24

  8. Part 1: Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) 0-1 at Week 24

    The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions 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=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicates 0-1 (no effect on patient's life), 2-5 (small effect on patient's life), 6-10 (moderate effect on patient's life), 11-20 (very large effect on patient's life), 21-30 (extremely large effect on patient's life)

    Measured: At Week 24

  9. Part 1: Percentage of Participants Achieving Children Dermatology Life Quality Index (cDLQI) 0-1 at Week 24

    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. The answers to the questions are generally scored on a 4-point scale from 0=not at all or question unanswered, 1=only a little, 2=quite a lot, 3=very much. cDLQI is calculated by summing the score of each question resulting in 0 to 30. Higher the score, the more impairment of the child's life is experienced.

    Measured: At Week 24

  10. Part 1: Percentage of Participants with DLQI >=4 at Baseline Achieving >=4-Point Improvement in DLQI

    DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions 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=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. High score is indicative of a poor QoL.

    Measured: Baseline up to Week 24

  11. Part 1: Percentage of Participants with cDLQI >=6 at Baseline Achieving >=6-Point Improvement in cDLQI

    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. The answers to the questions are generally scored on a 4-point scale from 0=not at all or question unanswered, 1=only a little, 2=quite a lot, 3=very much. cDLQI is calculated by summing the score of each question resulting in 0 to 30. Higher the score, the more impairment of the child's life is experienced.

    Measured: Baseline up to Week 24

  12. Part 1: Percentage of Participants with a Sleep-Loss Scale of >=2 Points at Baseline Achieving >= 2 Point Improvement at Week 24

    Sleep loss will be assessed by all participants using a patient-related outcome (PRO) instrument. Participants (and if applicable, with help of parents/caregiver if required) will rate their sleep on a 5-point Likert scale (with scores ranging from 0 [not at all] to 4 [unable to sleep at all]). Assessments will be recorded by the participant using an eDiary. The baseline Sleep-Loss Scale score will be determined based on the average of daily Sleep-Loss Scale scores during the 7 days immediately before the Day 1 or Baseline visit.

    Measured: At Week 24

  13. Part 1: Percentage of Participants with Patient-Oriented Eczema Measure (POEM) >=4 at Baseline Achieving >=4-Point Improvement in POEM

    The POEM is a 7-item, validated questionnaire completed by the participant (and, if applicable, with help of parents/caregiver if required) to assess disease symptoms. Participants are asked to respond to questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping. All answers carry equal weight, with a total possible score ranging from 0 to 28 (answers scored as: No days = 0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; every day = 4. A high score is indicative of a poor quality of life. POEM responses will be captured weekly using an eDiary.

    Measured: Baseline up to Week 24

  14. Part 1: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Related AEs, AEs Leading to Study Treatment Discontinuation, and Adverse Events of Special Interest (AESIs)

    An AE is defined as any untoward medical occurrence in a clinical trial participant, regardless of the administration of the IMP and its causal relationship to it. An AE can therefore be any unfavourable/unintended medical occurrence during the participation in the trial, including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, ECG abnormality, or an abnormal finding in the physical examination. An SAE is an AE, which falls into any of the following categories: death, is life-threatening, requires in-patient hospitalisation or prolongs existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect, or any other medically important event that may jeopardise the participant or may require intervention to prevent one of the other above outcomes. The following treatment-emergent AEs are being designated as AESIs: conjunctivitis, herpes simplex or zoster infection and parasitic infections.

    Measured: Baseline up Week 24

  15. Part 2: Percentage of Participants Achieving EASI Scores <=7, and <=3 at Week 36

    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. The severity of erythema, induration/papulation, excoriation, and lichenification will be assessed by the Investigator or trained designee on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. In addition, the extent of AD involvement in each of the 4 body areas will be assessed as a percentage by body area of head/neck, trunk, upper limbs, and lower limbs, and converted to a score of 0 (0%), 1 (0 to 9%), 2 (10 to 29%), 3 (30 to 49%), 4 (50 to 69%), 5 (70 to 89%) and 6 (90 to 100%).

    Measured: At Week 36

  16. Part 2: Percentage of Participants Achieving EASI 90 at Week 36

    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 90 is defined as 90% reduction from baseline in the EASI score.

    Measured: At Week 36

  17. Part 2: Percentage of Participants with Pruritus NRS >=4 at Baseline (Part 1) Achieving >=4-Point Improvement in Pruritus NRS at Week 36

    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: At Week 36

  18. Part 2: Percentage of Participants with Pruritus NRS 0 or 1 at Week 36

    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: At Week 36

  19. Part 2: Percentage of Participants Achieving DLQI 0-1 at Week 36

    The DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions 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=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL. DLQI scores indicates 0-1 (no effect on patient's life), 2-5 (small effect on patient's life), 6-10 (moderate effect on patient's life), 11-20 (very large effect on patient's life), 21-30 (extremely large effect on patient's life).

    Measured: At Week 36

  20. Part 2: Percentage of Participants Achieving cDLQI 0-1 at Week 36

    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. The answers to the questions are generally scored on a 4-point scale from 0=not at all or question unanswered, 1=only a little, 2=quite a lot, 3=very much. cDLQI is calculated by summing the score of each question resulting in 0 to 30. Higher the score, the more impairment of the child's life is experienced.

    Measured: At Week 36

  21. Part 2: Percentage of Participants with DLQI >=4 at Baseline (Part 1) Achieving >=4-Point Improvement in DLQI at Week 36

    DLQI is a 10-item validated questionnaire completed by the participant or caregiver used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions 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=not at all, 1=a little, 2=a lot, and 3=very much, giving a total score ranging from 0 to 30. High score is indicative of a poor QoL.

    Measured: At Week 36

  22. Part 2: Percentage of Participants with cDLQI >=6 at Baseline (Part 1) Achieving >=6-Point Improvement in cDLQI at Week 36

    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. The answers to the questions are generally scored on a 4-point scale from 0=not at all or question unanswered, 1=only a little, 2=quite a lot, 3=very much. cDLQI is calculated by summing the score of each question resulting in 0 to 30. Higher the score, the more impairment of the child's life is experienced.

    Measured: At Week 36

  23. Part 2: Percentage of Participants with a Sleep-Loss Scale of >=2 Points at Baseline (Part 1) Achieving >= 2 Point Improvement at Week 36

    Sleep loss will be assessed by all participants using a PRO instrument. Participants (and if applicable, with help of parents/caregiver if required) will rate their sleep on a 5-point Likert scale (with scores ranging from 0 [not at all] to 4 [unable to sleep at all]). Assessments will be recorded by the participant using an eDiary. The baseline Sleep-Loss Scale score will be determined based on the average of daily Sleep-Loss Scale scores during the 7 days immediately before the Day 1 or Baseline visit.

    Measured: At Week 36

  24. Part 2: Percentage of Participants with POEM >=4 at Baseline (Part 1) Achieving >=4-Point Improvement in POEM at Week 36

    The POEM is a 7-item, validated questionnaire completed by the participant (and, if applicable, with help of parents/caregiver if required) to assess disease symptoms. Participants are asked to respond to questions on skin dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping. All answers carry equal weight, with a total possible score ranging from 0 to 28 (answers scored as: No days = 0; 1-2 days = 1; 3-4 days = 2; 5-6 days = 3; every day = 4. A high score is indicative of a poor quality of life. POEM responses will be captured weekly using an eDiary.

    Measured: At Week 36

  25. Part 2: Percentage of Participants with TEAEs, SAEs, Related AEs, AEs Leading to Study Treatment Discontinuation, and AESIs

    An AE is defined as any untoward medical occurrence in a clinical trial participant, regardless of the administration of the IMP and its causal relationship to it. An AE can therefore be any unfavourable/unintended medical occurrence during the participation in the trial, including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, ECG abnormality, or an abnormal finding in the physical examination. An SAE is an AE, which falls into any of the following categories: death, is life-threatening, requires in-patient hospitalisation or prolongs existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect, or any other medically important event that may jeopardise the participant or may require intervention to prevent one of the other above outcomes. The following treatment-emergent AEs are being designated as AESIs: conjunctivitis, herpes simplex or zoster infection and parasitic infections.

    Measured: From Week 24 up to Week 68

Timeline

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

  1. First posted29 Jul 2024
  2. Study start3 Jul 2024
  3. Primary completion25 Apr 2027 (estimated)
  4. Study completion25 Apr 2027 (estimated)

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
Randomised
Intervention model
Parallel groups
Model description
Part 1 and Part 2 (Run-In Period): Open label; Part 2: Randomized and Double-Blind.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06526182
Sponsor's protocol ID
M-17923-34
Other IDs
2023-508235-31, 2023
Acronym
ADhope 2
Status last verified
Apr 2026
First submitted
24 Jul 2024
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lebrikizumab in people with Dermatitis, Atopic and Eczema, run by Almirall, S.A. at 4 sites in Spain.

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 13 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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?

Part 1: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score Less than or Equal to (<=) 7 at Week 24 (time frame: At Week 24). The study lists 3 primary outcomes in all. 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 NCT06526182.

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 21 Apr 2026.

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