Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients

Evaluating the Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients: A 24-Week Study

The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).

This study is a Phase II, single center, open-label, single-arm clinical trial. Study participation will last up to 32 weeks, including a 4-week screening period, a 24-week treatment period with all participants receiving lebrikizumab injections, and a 4-week safety follow up period.

Inclusion Criteria:

• Age 18-80
• Diagnosis of Prurigo Nodularis (PN) for at least 1 year
• Active PN with moderate-to-severe itch, several nodules, and presence of nodules in more than one part of the body
• Women of childbearing potential must agree to remain abstinent or use a highly effective contraceptive method during treatment and for at least 18 weeks after the last dose of study drug
• Male participants must agree to use an effective barrier contraceptive if sexually active with a woman of childbearing potential during treatment and for at least 18 weeks after the last dose of study drug

Exclusion Criteria:

• Prior participation in a lebrikizumab study
• History of anaphylaxis
• History of or active HIV
• Active hepatitis or known liver cirrhosis
• History of cancer in the past 5 years, except for fully treated early cervical cancer in situ or non-melanoma skin cancers (basal cell or squamous cell skin cancer) that have been successfully treated and resolved. This includes certain skin lymphomas such as mycosis fungoides.
• Uncontrolled chronic conditions that may require intermittent oral steroid use, such as severe uncontrolled asthma
• Current or recent parasitic infection
• Immunocompromised individuals
• Pregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study period
• Use of other treatments for PN during the study, such as topical, systemic, or light-based treatments
• Current or recent treatment with biologic drugs
• Use of drugs that have an effect on the immune system during the study and within 4 weeks of starting the study
• Receipt of phototherapy or light-based therapy within 4 weeks before starting the study
• Regular use of tanning booths or parlors within 4 weeks before starting the study
• Receipt of a live vaccine within 12 weeks before starting the study or planned receipt during the study
• Recent use of an experimental drug

Other protocol-defined Inclusion/Exclusion Criteria apply.