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Phase 3 N=1,153 Double-blind Treatment

Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)

Atopic Dermatitis

Enrolled (actual)
1,153
Serious AEs
4.0%
Results posted
Aug 2025
Primary outcome: Primary: Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events — 2.1; 4.5 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Lebrikizumab (Biological)
Age
Pediatric, Adult, Older Adult · 12+ yrs
Sex
All
Sponsor
Eli Lilly and Company
Primary completion
Jul 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events
2.1; 4.5
SECONDARY
Primary Treatment Period: Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100
80.1; 60.6
SECONDARY
Primary Treatment Period: Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100
90.4; 79.4

Summary

This is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis. It will last up to 33 months.

Eligibility Criteria

Inclusion Criteria for participants coming from a parent study:

Participants must meet all the following criteria to be eligible for this study:

  • Received treatment in a lebrikizumab study, NCT04146363, NCT04178967, NCT04250337, NCT04250350 and have adequately completed the study treatments and last patient visit of the parent trial.
  • For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo.

Exclusion Criteria for participants coming from a parent study:

Participants meeting any of the criteria below will not be included in this study:

  • Participants who, during their participation in the parent trial, developed a serious adverse event (SAE) 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. *
  • Participants who, during their participation in the parent trial, developed an AE that was deemed related to lebrikizumab and led to study treatment discontinuation, 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 previous parent study 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.). *
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Open-Label Addendum Inclusion Criteria:

Participants must meet all the following criteria to be eligible for this study addendum:

  • Male or female adults and adolescents (≥12 to <18 years of age and weighing ≥40 kilogram (kg).
  • Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening.
  • Eczema Area and Severity Index (EASI) score ≥16 at baseline.
  • Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at baseline.
  • ≥10% body surface area (BSA) of AD involvement at baseline.
  • History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.

Open-Label Addendum Exclusion Criteria:

Participants meeting any of the criteria below will be excluded from this study addendum:

  • Have received a dose of lebrikizumab in any prior lebrikizumab clinical study.
  • History of anaphylaxis
  • Treatment with topical prescription moisturizers, corticosteroids, calcineurin inhibitors, or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to baseline.
  • Treatment with any of the following agents within 4 weeks prior to the baseline.
  • Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon gamma (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc.)
  • Phototherapy and photochemotherapy (PUVA) for AD.
  • Treatment with the following prior to baseline:
  • Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
  • Phototherapy and photochemotherapy (PUVA) for AD.
  • Treatment with the following prior to baseline:
  • An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
  • B Cell-depleting biologics, including rituximab, within 6 months.
  • Other Biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
  • Regular use (more than 2 uses per week) of a tanning booth/parlor within 4 weeks of baseline.
  • Treatment with a
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04392154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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