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.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients
