Trial · NCT03568318
A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
NCT03568318, Phase 3, Active not recruiting, AbbVie; results first posted 2022-03-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis. Trials, record NCT03568318. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03568318
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
- NCT number
- NCT03568318
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,533 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Atopic Dermatitis
- Interventions
- Placebo, Upadacitinib, Topical corticosteroids (TCS)
- First posted
- 2018-06-26
- Last updated
- 2025-12-23
- Other registries' IDs
- eudract:2017-005126-37
- Results first posted
- 2022-03-31
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 | Baseline and Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. |
| Primary | Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 | Baseline and Week 16 | The vIGA-AD is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: * 0 - Clear: No inflammatory signs of AD; * 1 - Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification; * 2 - Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification. No oozing or crusting; * 3 - Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present; * 4 - Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. |
| Secondary | Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16 | Baseline (last available rolling average before the first dose of study drug) and Week 16 | Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. |
| Secondary | Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16 | Baseline and Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. |
| Secondary | Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4 | Baseline (last available rolling average before the first dose of study drug) and Week 4 | Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. |
| Secondary | Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 4 | Baseline and Week 4 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score. |
| Secondary | Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2 | Baseline and Week 2 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. An EASI 75 response is defined as at least a 75% reduction (improvement) from Baseline in EASI score. |
| Secondary | Main Study: Percentage of Participants Achieving an EASI 90 Response at Week 4 | Baseline and Week 4 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. |
| Secondary | Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16 | Baseline and Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored from 0 \[none\], to 3 \[severe\]) for redness, thickness, scratching, and lichenification. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. The percentage of participants with an EASI 100 response at Week 16 was pre-specified as a ranked secondary endpoint for participants in the Upadacitinib 30 mg + Topical Corticosteroids group versus Placebo + Topical Corticosteroids group only. |
| Secondary | Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1 | Baseline (last available rolling average before the first dose of study drug) and Week 1 | Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). Pruritus NRS was analyzed based on weekly rolling averages of daily scores. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 | Baseline and Week 16 | The intent-to-treat population for the main study (ITT\_M) includes all participants who were randomized in the main study (adults and adolescents). Non-responder imputation incorporating multiple imputation to handle missing data due to coronavirus disease 2019 pandemic (COVID-19) (NRI-C) was used.~The pre-specified primary analysis included participants enrolled in the main study only; Efficacy analyses of adolescent participants were conducted separately and are reported below. | percentage of participants | NUMBER |
| PRIMARY | Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 | Baseline and Week 16 | Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16 | Baseline (last available rolling average before the first dose of study drug) and Week 16 | Intent-to-treat population for the main study with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16 | Baseline and Week 16 | Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 4 | Baseline (last available rolling average before the first dose of study drug) and Week 4 | Intent-to-treat population for the main study with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 4 | Baseline and Week 4 | Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving an EASI 75 Response at Week 2 | Baseline and Week 2 | Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving an EASI 90 Response at Week 4 | Baseline and Week 4 | Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16 | Baseline and Week 16 | Intent-to-treat population for the main study; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | percentage of participants | NUMBER |
| SECONDARY | Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 1 | Baseline (last available rolling average before the first dose of study drug) and Week 1 | Intent-to-treat population for the main study with Worst Pruritus NRS (weekly average) ≥ 4 at Baseline; Non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C) was used. | percentage of participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 | Placebo + Topical Corticosteroids | 26.4 | 95% Confidence Interval 21.5 to 31.4 | percentage of participants | |
| Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 | Upadacitinib 15 mg + Topical Corticosteroids | 64.6 | 95% Confidence Interval 59.1 to 70.0 | percentage of participants | |
| Main Study: Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 | Upadacitinib 30 mg + Topical Corticosteroids | 77.1 | 95% Confidence Interval 72.3 to 81.9 | percentage of participants | |
| Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 | Placebo + Topical Corticosteroids | 10.9 | 95% Confidence Interval 7.4 to 14.4 | percentage of participants | |
| Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 | Upadacitinib 15 mg + Topical Corticosteroids | 39.6 | 95% Confidence Interval 34.1 to 45.2 | percentage of participants | |
| Main Study: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 With a Reduction From Baseline of ≥ 2 Points at Week 16 | Upadacitinib 30 mg + Topical Corticosteroids | 58.6 | 95% Confidence Interval 53.0 to 64.2 | percentage of participants | |
| Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16 | Placebo + Topical Corticosteroids | 15.0 | 95% Confidence Interval 10.9 to 19.0 | percentage of participants | |
| Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16 | Upadacitinib 15 mg + Topical Corticosteroids | 51.7 | 95% Confidence Interval 46.0 to 57.5 | percentage of participants | |
| Main Study: Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus Numerical Rating Scale (NRS) at Week 16 | Upadacitinib 30 mg + Topical Corticosteroids | 63.9 | 95% Confidence Interval 58.4 to 69.4 | percentage of participants | |
| Main Study: Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16 | Placebo + Topical Corticosteroids | 13.2 | 95% Confidence Interval 9.4 to 17.0 | percentage of participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adults: Placebo + Topical Corticosteroids | 264 | |
| Overall Study | STARTED | Adults: Upadacitinib 15 mg + Topical Corticosteroids | 261 | |
| Overall Study | STARTED | Adults: Upadacitinib 30 mg + Topical Corticosteroids | 260 | |
| Overall Study | STARTED | Adolescents: Placebo + Topical Corticosteroids | 63 | |
| Overall Study | STARTED | Adolescents: Upadacitinib 15 mg + Topical Corticosteroids | 60 | |
| Overall Study | STARTED | Adolescents: Upadacitinib 30 mg + Topical Corticosteroids | 60 | |
| Overall Study | Received Study Drug | Adults: Placebo + Topical Corticosteroids | 264 | |
| Overall Study | Received Study Drug | Adults: Upadacitinib 15 mg + Topical Corticosteroids | 261 | |
| Overall Study | Received Study Drug | Adults: Upadacitinib 30 mg + Topical Corticosteroids | 260 | |
| Overall Study | Received Study Drug | Adolescents: Placebo + Topical Corticosteroids | 62 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events252
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 | ABDOMINAL PAIN | Gastrointestinal disorders | Adults: Placebo + Topical Corticosteroids | 0 | 264 | 0 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Adults: Upadacitinib 15 mg + Topical Corticosteroids | 6 | 261 | 7 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Adults: Upadacitinib 30 mg + Topical Corticosteroids | 2 | 260 | 3 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Adolescents: Placebo + Topical Corticosteroids | 1 | 62 | 1 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Adolescents: Upadacitinib 15 mg + Topical Corticosteroids | 0 | 60 | 0 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Adolescents: Upadacitinib 30 mg + Topical Corticosteroids | 3 | 60 | 3 |
| other | DIARRHOEA | Gastrointestinal disorders | Adults: Placebo + Topical Corticosteroids | 4 | 264 | 4 |
| other | DIARRHOEA | Gastrointestinal disorders | Adults: Upadacitinib 15 mg + Topical Corticosteroids | 10 | 261 | 10 |
| other | DIARRHOEA | Gastrointestinal disorders | Adults: Upadacitinib 30 mg + Topical Corticosteroids | 9 | 260 | 10 |
| other | DIARRHOEA | Gastrointestinal disorders | Adolescents: Placebo + Topical Corticosteroids | 4 | 62 | 4 |
1 to 10 of 252Source ClinicalTrials.gov
See all 252 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adults: Placebo + Topical Corticosteroids | 0 | 264 |
| Total, all-cause mortality | Adults: Upadacitinib 15 mg + Topical Corticosteroids | 0 | 261 |
| Total, all-cause mortality | Adults: Upadacitinib 30 mg + Topical Corticosteroids | 0 | 260 |
| Total, all-cause mortality | Adolescents: Placebo + Topical Corticosteroids | 0 | 62 |
| Total, all-cause mortality | Adolescents: Upadacitinib 15 mg + Topical Corticosteroids | 0 | 60 |
| Total, all-cause mortality | Adolescents: Upadacitinib 30 mg + Topical Corticosteroids | 0 | 60 |
| Total, other adverse events | Adults: Placebo + Topical Corticosteroids | 99 | 264 |
| Total, other adverse events | Adults: Upadacitinib 15 mg + Topical Corticosteroids | 111 | 261 |
| Total, other adverse events | Adults: Upadacitinib 30 mg + Topical Corticosteroids | 123 | 260 |
| Total, other adverse events | Adolescents: Placebo + Topical Corticosteroids | 21 | 62 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers11
The papers the trial lists on ClinicalTrials.gov.
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.
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