Drug Trials Snapshots: ANZUPGO

ANZUPGO (delgocitinib) (an-ZUP-go) Leo Pharma Inc. Approval date: July 23, 2025 DRUG TRIALS SNAPSHOT SUMMARY: What is the drug for? ANZUPGO is a Janus kinase inhibitor that is indicated for the treatment of adults with moderate to severe chronic hand eczema (CHE) who have had an inadequate response to, or for whom topical corticosteroids are not advisable. How is this drug used? ANZUPGO is a topical product that is taken twice a day. Who participated in the clinical trials? The FDA approved ANZUPGO based on evidence from two clinical trials of 960 adult patients with moderate to severe CHE who had a history of inadequate response to, or for whom topical corticosteroids were not advisable. The trials were conducted at 99 sites in 10 countries including Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, and the United Kingdom. Among the 960 enrolled patients, 959 were evaluated for efficacy (Full Analysis Set) and safety. How were the trials designed? ANZUPGO was evaluated in two clinical trials of 960 patients with moderate to severe CHE who had a history of inadequate response to, or for whom topical corticosteroids were not advisable. In both trials, patients were randomized to receive either ANZUPGO or vehicle. Patients applied study product twice daily to affected areas on the hands and wrists for 16 weeks. The primary efficacy endpoint was the proportion of patients who achieved Investigator’s Global Assessment for CHE (IGA-CHE) treatment success (IGA-CHE TS) at Week 16, defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline. DEMOGRAPHICS SNAPSHOT Figure 1 summarizes how many male and female patients were enrolled in the combined clinical trials used to evaluate the efficacy of ANZUPGO. Figure 1. Baseline Demographics by Sex, Full Analysis Set Source: Adapted from FDA Review Figure 2 summarizes how patients by race were enrolled in the combined clinical trials used to evaluate the efficacy of ANZUPGO. Figure 2. Baseline Demographics by Race, Full Analysis Set Source: Adapted from FDA Review Figure 3 summarizes how patients by age were enrolled in the combined clinical trials used to evaluate the efficacy of ANZUPGO. Figure 3. Baseline Demographics by Age, Full Analysis Set Source: Adapted from FDA Review Figure 4 summarizes how patients by ethnicity were enrolled in the combined clinical trials used to evaluate the efficacy of ANZUPGO. Figure 4. Baseline Demographics by Ethnicity, Full Analysis Set Source: Adapted from FDA Review What are the benefits of this drug? In two trials, more patients achieved clear or almost clear skin after 16 weeks of treatment with ANZUPGO compared to those who were treated with vehicle. Were there any differences in how well the drug worked in clinical trials among sex, race, and age? Sex: ANZUPGO worked similarly in males and females. Race: The number of patients of races other than White was limited; therefore, differences in response among races could not be determined. Age: The number of patients of older than 65 years of age was limited; therefore, differences in response among age groups could not be determined. What are the possible side effects? Most common side effects include application site pain, numbness (paresthesia), itchiness (pruritus), redness (erythema), and bacterial skin infections including finger cellulitis, paronychia, other skin infections, lower white blood cells (leukopenia) including decreased neutrophils (a type of white blood cell). ANZUPGO may increase the risk of infections. Were there any differences in side effects among sex, race and age? Sex: The occurrence of side effects was more common in females than males. Race: The occurrence of side effects was more common in White patients than Asian and Black or African American patients. The number of patients of other races was limited; therefore, differences in side effects among other races could not be determined. Age: The occurrence of side effects was more common in patients ≥65 years of age than patients between 18 to 64 years of age. GLOSSARY CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested. EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial. PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo. SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups. PRESCRIBING INFORMATION