Trial · NCT05601882
A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
NCT05601882, Phase 3, Completed, AbbVie; results first posted 2025-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis. Trials, record NCT05601882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05601882
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
- NCT number
- NCT05601882
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 920 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Atopic Dermatitis
- Interventions
- Dupilumab, Upadacitinib
- First posted
- 2022-11-01
- Last updated
- 2025-02-14
- Other registries' IDs
- eudract:2022-002482-15
- Results first posted
- 2025-02-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 | Baseline and Week 16 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). |
| Secondary | Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 16 | Baseline and Week 16 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). |
| Secondary | Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Among Participants With Baseline WP-NRS > 1 | Baseline and Week 16 | The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). |
| Secondary | Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 Among Those With Baseline WP-NRS ≥ 4 | Baseline and Week 16 | The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). |
| Secondary | Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 Among Participants With Baseline WP-NRS > 1 | Baseline and Week 4 | The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). |
| Secondary | Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 2 Among Participants With Baseline WP-NRS > 1 | Baseline and Week 2 | The Worst Pruritus NRS is an assessment tool that participants used to report the intensity of their pruritus during a 24-hour recall period using an electronic hand-held device. Participants rated itch (pruritus) intensity at its worst during the past 24 hours on an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). |
| Secondary | Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 4 | Baseline and Week 4 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). |
| Secondary | Percentage of Participants Achieving a ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 2 | Baseline and Week 2 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). |
| Secondary | Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 16 | Baseline and Week 16 | The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) assessed for severity on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement is assessed as a percentage by body area of head, trunk (including the genital area), upper extremities, and lower extremities (including the buttocks), and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 | Baseline and Week 16 | Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 16 | Baseline and Week 16 | Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Among Participants With Baseline WP-NRS > 1 | Baseline and Week 16 | Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 Among Those With Baseline WP-NRS ≥ 4 | Baseline and Week 16 | Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 Among Participants With Baseline WP-NRS > 1 | Baseline and Week 4 | Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 2 Among Participants With Baseline WP-NRS > 1 | Baseline and Week 2 | Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 4 | Baseline and Week 4 | Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 2 | Baseline and Week 2 | Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a 100% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 100) at Week 16 | Baseline and Week 16 | Intent-to-Treat (ITT) Population of Period 1 (ITT\_1 Population): all participants who were randomized at Baseline; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or any other missing data that can be reasonably assumed to be Missing at Random (NRI-MI) was used. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 | Dupilumab (Period 1) | 8.9 | 95% Confidence Interval 6.3 to 11.5 | percentage of participants | |
| Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 | Upadacitinib (Period 1) | 19.9 | 95% Confidence Interval 16.2 to 23.5 | percentage of participants | |
| Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 16 | Dupilumab (Period 1) | 22.5 | 95% Confidence Interval 18.7 to 26.3 | percentage of participants | |
| Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) at Week 16 | Upadacitinib (Period 1) | 40.8 | 95% Confidence Interval 36.3 to 45.3 | percentage of participants | |
| Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Among Participants With Baseline WP-NRS > 1 | Dupilumab (Period 1) | 15.5 | 95% Confidence Interval 12.2 to 18.8 | percentage of participants | |
| Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Among Participants With Baseline WP-NRS > 1 | Upadacitinib (Period 1) | 30.2 | 95% Confidence Interval 26.0 to 34.4 | percentage of participants | |
| Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 Among Those With Baseline WP-NRS ≥ 4 | Dupilumab (Period 1) | 38.1 | 95% Confidence Interval 33.6 to 42.5 | percentage of participants | |
| Percentage of Participants Achieving an Improvement (Reduction) in Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at Week 16 Among Those With Baseline WP-NRS ≥ 4 | Upadacitinib (Period 1) | 54.7 | 95% Confidence Interval 50.1 to 59.3 | percentage of participants | |
| Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 Among Participants With Baseline WP-NRS > 1 | Dupilumab (Period 1) | 2.8 | 95% Confidence Interval 1.3 to 4.3 | percentage of participants | |
| Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 4 Among Participants With Baseline WP-NRS > 1 | Upadacitinib (Period 1) | 16.1 | 95% Confidence Interval 12.7 to 19.5 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (Baseline - Week 16) | STARTED | Dupilumab (Period 1) | 462 | |
| Period 1 (Baseline - Week 16) | STARTED | Upadacitinib (Period 1) | 458 | |
| Period 1 (Baseline - Week 16) | STARTED | Dupilumab -> Upadacitinib (Period 2) | 0 | |
| Period 1 (Baseline - Week 16) | STARTED | Upadacitinib -> Upadacitinib 30 mg (Period 2) | 0 | |
| Period 1 (Baseline - Week 16) | COMPLETED | Dupilumab (Period 1) | 423 | |
| Period 1 (Baseline - Week 16) | COMPLETED | Upadacitinib (Period 1) | 418 | |
| Period 1 (Baseline - Week 16) | COMPLETED | Dupilumab -> Upadacitinib (Period 2) | 0 | |
| Period 1 (Baseline - Week 16) | COMPLETED | Upadacitinib -> Upadacitinib 30 mg (Period 2) | 0 | |
| Period 1 (Baseline - Week 16) | NOT COMPLETED | Dupilumab (Period 1) | 39 | |
| Period 1 (Baseline - Week 16) | NOT COMPLETED | Upadacitinib (Period 1) | 40 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | NASOPHARYNGITIS | Infections and infestations | Dupilumab (Period 1) | 35 | 462 | 43 |
| other | NASOPHARYNGITIS | Infections and infestations | Upadacitinib (Period 1) | 58 | 458 | 74 |
| other | NASOPHARYNGITIS | Infections and infestations | Dupilumab -> Upadacitinib (Period 2) | 18 | 208 | 20 |
| other | NASOPHARYNGITIS | Infections and infestations | Upadacitinib -> Upadacitinib 30 mg (Period 2) | 12 | 147 | 13 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Dupilumab (Period 1) | 22 | 462 | 28 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Upadacitinib (Period 1) | 27 | 458 | 33 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Dupilumab -> Upadacitinib (Period 2) | 12 | 208 | 12 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Upadacitinib -> Upadacitinib 30 mg (Period 2) | 7 | 147 | 9 |
| other | HEADACHE | Nervous system disorders | Dupilumab (Period 1) | 16 | 462 | 20 |
| other | HEADACHE | Nervous system disorders | Upadacitinib (Period 1) | 27 | 458 | 32 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dupilumab (Period 1) | 0 | 462 |
| Total, all-cause mortality | Upadacitinib (Period 1) | 0 | 458 |
| Total, all-cause mortality | Dupilumab -> Upadacitinib (Period 2) | 0 | 208 |
| Total, all-cause mortality | Upadacitinib -> Upadacitinib 30 mg (Period 2) | 0 | 147 |
| Total, other adverse events | Dupilumab (Period 1) | 87 | 462 |
| Total, other adverse events | Upadacitinib (Period 1) | 156 | 458 |
| Total, other adverse events | Dupilumab -> Upadacitinib (Period 2) | 57 | 208 |
| Total, other adverse events | Upadacitinib -> Upadacitinib 30 mg (Period 2) | 30 | 147 |
| Total, serious adverse events | Dupilumab (Period 1) | 5 | 462 |
| Total, serious adverse events | Upadacitinib (Period 1) | 4 | 458 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41533220 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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