Drug Trials Snapshots: ANZUPGO
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the ANZUPGO Prescribing Information for all of the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
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.
How were the trials designed?
ANZUPGO was evaluated in two randomized, double-blind, vehicle-controlled, 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.
Disease severity of enrolled patients was defined using the IGA-CHE score and the Hand Eczema Symptom Diary (HESD) itch score (weekly average). The IGA-CHE is the investigator’s overall assessment of CHE at a given time point on a scale ranging from 0 (clear) to 4 (severe). The HESD itch score assesses disease severity of pruritus using a scale ranging from 0 (no symptoms) to 10 (severe symptoms). Patients enrolled in these three trials had an IGA-CHE score of 3 or 4 (moderate or severe, respectively) and a HESD itch score (weekly average) of ≥4 points at baseline.
The primary efficacy endpoint was the proportion of patients who achieved 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
Who participated in the trials?
Table 1. Baseline Demographics of Efficacy Trials by Demographic, FAS1
| Demographic | DELTA 1 | DELTA 2 | ||
|---|---|---|---|---|
| ANZUPGO N=325 |
Vehicle N=162 |
ANZUPGO N=313 |
Vehicle N=159 |
|
| Age, years | ||||
| Mean (SD) | 44.3 (14.3) | 42.9 (14.1) | 45.3 (14.6) | 42.6 (14.3) |
| Median | 45.0 | 42.5 | 46.0 | 42.0 |
| Min, max | 19, 87 | 20, 73 | 18, 83 | 18, 86 |
| Age group, years, n (%) | ||||
| 18 to <65 | 297 (91.4) | 154 (95.1) | 285 (91.1) | 150 (94.3) |
| 65 to <85 | 27 (8.3) | 8 (4.9) | 28 (8.9) | 8 (5.0) |
| ≥85 | 1 (0.3) | 0 | 0 | 1 (0.6) |
| Sex, n (%) | ||||
| Female | 202 (62.2) | 104 (64.2) | 203 (64.9) | 108 (67.9) |
| Male | 123 (37.8) | 58 (35.8) | 110 (35.1) | 51 (32.1) |
| Race, n (%) | ||||
| White | 283 (87.1) | 144 (88.9) | 294 (93.9) | 146 (91.8) |
| American Indian or Alaska Native | 1 (0.3) | 0 | 0 | 0 |
| Asian | 14 (4.3) | 5 (3.1) | 8 (2.6) | 7 (4.4) |
| Black or African American | 3 (0.9) | 1 (0.6) | 2 (0.6) | 1 (0.6) |
| Multiple2 | 2 (0.6) | 1 (0.6) | 1 (0.3) | 3 (1.9) |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 1 (0.3) | 0 |
| Not reported | 20 (6.2) | 11 (6.8) | 2 (0.6) | 1 (0.6) |
| Other | 2 (0.6) | 0 | 5 (1.6) | 1 (0.6) |
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 14 (4.3) | 4 (2.5) | 2 (0.6) | 5 (3.1) |
| Not Hispanic or Latino | 292 (89.8) | 147 (90.7) | 309 (98.7) | 152 (95.6) |
| Not reported | 19 (5.8) | 11 (6.8) | 2 (0.6) | 2 (1.3) |
| Region, n (%) | ||||
| Europe | 260 (80.0) | 130 (80.2) | 249 (79.6) | 126 (79.2) |
| North America | 65 (20.0) | 32 (19.8) | 64 (20.4) | 33 (20.8) |
Source: Adapted from FDA Review
1 FAS: all subjects randomized and dosed.
Abbreviations: FAS, full analysis set; SD, standard deviation
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.
What are the benefits of this drug (results of trials used to assess efficacy)?
Table 2 summarizes efficacy results in the clinical trials. Efficacy was assessed at Week 16 with the proportion of patients with an IGA-CHE of 0 (clear) or 1 (almost clear).
Table 2. Efficacy Results of ANZUPGO in Adults With Moderate to Severe CHE at Week 16 in DELTA 1 and DELTA 2
| Endpoint | DELTA 1 | DELTA 2 | ||
|---|---|---|---|---|
| ANZUPGO N=325 |
Vehicle N=162 |
ANZUPGO N=313 |
Vehicle N=159 |
|
| IGA-CHE TS, % (n/Ns) respondersa,b | 20 (64/325) | 10 (16/162) | 29 (91/313) | 7 (11/159) |
| Difference from Vehicle, % (95% CI) | 10 (4, 16) | 22 (16, 29) | ||
Source: Adapted from ANZUPGO Prescribing Information
a Data after initiation of rescue treatment, permanent discontinuation of treatment, or missing data were considered non-response.
b IGA-CHE TS was defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline.
Abbreviations: CHE, chronic hand eczema; CI, confidence interval; IGA-CHE TS, Investigator’s Global Assessment for chronic hand eczema treatment success; N, number of subjects in the full analysis set (all subjects randomized and dosed; n, number of patients meeting criteria; Ns, total number of patients for each specific subgroup and were assigned to that specific arm
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.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Table 3 and Table 4 summarize the results of the primary efficacy endpoint at Week 16 by age, sex, race, and ethnicity.
Table 3. Results for IGA-CHE Treatment Success1 at Week 16 by Subgroup, Trial DELTA 1, FAS2
| Subgroup (NA, NV) | ANZUPGO N=325 % |
Vehicle N=162 % |
Difference % (95% CI)3 |
|---|---|---|---|
| Age, years | |||
| <65 (297, 154) | 20.5 | 10.4 | 10.1 (3.5, 16.8) |
| ≥65 (28, 8) | 10.7 | 0 | 10.7 (−0.7, 22.2) |
| Sex | |||
| Female (202, 104) | 19.8 | 14.4 | 5.4 (−3.3, 14.1) |
| Male (123, 58) | 19.5 | 1.7 | 17.8 (10.0, 25.6) |
| Race | |||
| White (283, 144) | 19.8 | 11.1 | 8.7 (1.8, 15.6) |
| Asian (14, 5) | 28.6 | 0 | 28.6 (4.9, 52.2) |
| Black or African American (3,1) | 0 | 0 | Not estimable |
| Other (2, 0) | 0 | - | Not estimable |
| American Indian or Alaska Native (1, 0) | 0 | - | Not estimable |
| Ethnicity | |||
| Hispanic or Latino (14, 4) | 7.1 | 0 | 7.1 (−6.3, 20.6) |
| Non-Hispanic or Latino (292, 147) | 20.5 | 10.9 | 9.7 (2.8, 16.5) |
Source: Adapted from FDA Review
1 IGA-CHE treatment success is defined as IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.
2 FAS: all subjects randomized and dosed. Data after initiation of rescue treatment, permanent discontinuation of treatment, or missing data were considered nonresponse.
3 Difference and 95% CI are from Cochran-Mantel-Haenszel test for general association.
Abbreviations: CI, confidence interval; FAS, full analysis set; IGA-CHE, Investigator’s Global Assessment for chronic hand eczema; N, number of subjects in treatment arm; NA, number of subjects who received ANZUPGO in the subgroup, NV, number of subjects who received vehicle cream in the subgroup
Table 4. Results for IGA-CHE Treatment Success1 at Week 16 by Subgroup, Trial DELTA 2, FAS2
| Subgroup (NA, NV) | ANZUPGO N=313 % |
Vehicle N=159 % |
Difference % (95 CI)3 |
|---|---|---|---|
| Age, years | |||
| <65 (285, 150) | 29.1 | 6.7 | 22.5 (15.8, 29.1) |
| ≥65 (28, 9) | 28.6 | 11.1 | 17.5 (−9.0, 43.9) |
| Sex | |||
| Female (203, 108) | 31.5 | 8.3 | 23.2 (14.9, 31.4) |
| Male (110, 51) | 24.5 | 3.9 | 20.6 (11.0, 30.3) |
| Race | |||
| White (294, 146) | 29.9 | 7.5 | 22.4 (15.6, 29.2) |
| Asian (8, 7) | 0 | 0 | Not estimable |
| Black or African American (2,1) | 50.0 | 0 | 50.0 (−19.3, 119.3) |
| Native Hawaiian or other Pacific Islander (1, 0) | 0 | - | Not estimable |
| Other (5, 1) | 20.0 | 0 | 20.0 (−15.1, 55.1) |
| Ethnicity | |||
| Hispanic or Latino (2, 5) | 0 | 0 | Not estimable |
| Non-Hispanic or Latino (309, 152) | 29.4 | 7.2 | 22.2 (15.7, 28.8) |
Source: Adapted from FDA Review
1 IGA-CHE treatment success is defined as IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.
2 FAS: all subjects randomized and dosed. Data after initiation of rescue treatment, permanent discontinuation of treatment, or missing data were considered nonresponse.
3 Difference and 95% CI are from Cochran-Mantel-Haenszel test for general association.
Abbreviations: CI, confidence interval; FAS, full analysis set; IGA-CHE, Investigator’s Global Assessment for chronic hand eczema; N, number of subjects in treatment arm; NA, number of subjects who received ANZUPGO in the subgroup, NV, number of subjects who received vehicle cream in the subgroup
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.
What are the possible side effects (results of trials used to assess safety)?
In DELTA 1 and DELTA 2, adverse reactions that were reported in ≤1% of subjects in the ANZUPGO group were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections including finger cellulitis, paronychia, other skin infections, leukopenia, and neutropenia.
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.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
There were no substantial differences in the risk of treatment-emergent adverse events (TEAEs) in any subgroup. However, the overall safety database and individual subgroup sample sizes were not sufficient to detect clinically meaningful differences in the frequency of TEAEs between individual subgroups.
TEAEs by Sex subgroup: A higher proportion of female (6.4%) than male (3.4%) subjects in the ANZUPGO group and more female (9.9%) than male (2.8%) subjects in the vehicle group were reported with TEAEs during the overall period.
TEAEs by Race and Ethnicity: A higher proportion of White (5.5%) compared to Asian (4.5%) and Black or African American (0%) subjects in ANZUPGO group and more Asian (8.3%) than White (7.2%) and Black or African American (0%) subjects in vehicle group were reported with TEAEs during the overall period. A higher proportion of Hispanic (12.5%) compared to Not Hispanic (5.3%) subjects in ANZUPGO group and more Not Hispanic (23.1%) than Hispanic (0%) subjects in vehicle group were reported with TEAEs during the overall period.
TEAEs by Age Group: A higher proportion of subjects ≥65 years of age (9.1%) compared to subjects <65 years of age (5.0%) in the ANZUPGO group and more subjects <65 years of age (7.6%) compared to subjects ≥65 years of age in the vehicle group (6.2%) were reported with TEAEs during the overall period.
Table 5. Number of Subjects Experiencing Side Effects by Subgroup, Trials DELTA 1 and DELTA 2, Safety Population
| Subgroup | ANZUPGO N=683 n/Ns (%) |
Vehicle N=321 n/Ns (%) |
|---|---|---|
| Age group, years | ||
| 18 to <65 | 29/582 (5.0) | 23/304 (7.6) |
| ≥65 to <85 | 5/55 (9.1) | 1/16 (6.2) |
| ≥85 | 0/1 (0) | 0/1 (0) |
| Sex | ||
| Female | 26/405 (6.4) | 21/212 (9.9) |
| Male | 8/233 (3.4) | 3/109 (2.8) |
| Race | ||
| White | 32/577 (5.5) | 21/290 (7.2) |
| Asian | 1/22 (4.5) | 1/12 (8.3) |
| Black or African American | 0/5 (0) | 0/2 (0) |
| American Indian or Alaska Native | 0/1 (0) | 0/0 (NA) |
| Native Hawaiian or other Pacific Islander | 0/1 (0) | 0/0 (NA) |
| Other | 0/7 (0) | 0/1 (0) |
| Multiple | 0/3 (0) | 0/4 (0) |
| Not reported | 1/22 (4.5) | 2/12 (16.7) |
| Ethnicity | ||
| Hispanic or Latino | 2/16 (12.5) | 0/9 (0) |
| Not Hispanic or Latino | 32/601 (5.3) | 21/299 (7.0) |
| Not reported | 0/21 (0) | 3/13 (23.1) |
Source: Adapted from FDA Review
Table includes adverse events determined to be “possibly related” or “probably related” to treatment.
Abbreviations: N, number of patients in treatment arm; n, number of patients with adverse event; NA, not applicable; Ns, total number of patients for each specific subgroup and were assigned to that specific arm
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.
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