A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)
A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)
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.
Participants who have completed participation in a Dermira- or Lilly-sponsored lebrikizumab study (parent study), DRM06-AD04 (NCT04146363), DRM06-AD05 (NCT04178967), DRM06-AD06 (NCT04250337), DRM06-AD17 (NCT04250350) or DRM06- AD18 (NCT04626297), will be offered the opportunity to enroll in this study. Participants may either be blinded or not blinded, depending on their parent study assignment.
This study will also be open to an additional approximately 100 participants in the United States (addendum) who have not completed participation in a Dermira- or Lilly-sponsored lebrikizumab study. Treatment will not be blinded.
This study will also include an Addendum to extend the study treatment period by an additional 32 weeks and to add a treatment arm testing dosing every 8 weeks. This Addendum will apply to existing study participants in selected countries. Treatment will not be blinded.
Inclusion Criteria for participants coming from a parent study:
Participants must meet all the following criteria to be eligible for this study:
Exclusion Criteria for participants coming from a parent study:
Participants meeting any of the criteria below will not be included in this study:
Open-Label Addendum Inclusion Criteria:
Participants must meet all the following criteria to be eligible for this study addendum:
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.
Treatment with the following prior to baseline:
Treatment with the following prior to baseline:
Regular use (more than 2 uses per week) of a tanning booth/parlor within 4 weeks of baseline.
Treatment with a live (attenuated) vaccine within 12 weeks of the baseline or planned during the study.
Uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma, (as defined by the investigator).
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
Evidence of active acute or chronic hepatitis
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
History of malignancy, including mycosis fungoides, within 5 years before screening, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
Open-Label Extension Addendum Inclusion Criteria:
Have completed Week 100 of Study KGAA and have not yet completed the safety follow-up visit for the main study.
Open-Label Extension Addendum Exclusion Criteria:
Have initiated treatment with a medication prohibited by Study KGAA before addendum baseline. This includes use of biologics for AD (for example, dupilumab and tralokinumab) during the safety follow-up period of Study KGAA.
Los Angeles, California 90025, United States
Los Angeles, California 90033, United States
San Diego, California 92123, United States
Washington D.C., District of Columbia 20037, United States
Hackensack, New Jersey 07601, United States
North York, Ontario M2M4J5, Canada
Talinn, 10134, Estonia
Münster, North Rhine-Westphalia 48149, Germany
Dresden, Saxony 01307, Germany
Vilnius, 08406, Lithuania
Iwonicz-Zdrój, Podkarpackie Voivodeship 38-440, Poland
Szczecin, West Pomeranian Voivodeship 70-332, Poland
Bialystok, 15-369, Poland
Lodz, Łódź Voivodeship 90-436, Poland
Poshtova Square 2, Zaporizhzhya 69063, Ukraine
Kharkiv, 61038, Ukraine