A Phase 3 interventional study of Upadacitinib in Atopic Dermatitis, sponsored by AbbVie. Completed at 116 sites in 22 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed.
Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.
1,443 studies on the registry are indexed under Dermatitis, Atopic; 253 are open to participants now.
This study's enrollment of 475 is above the median of 83 across 1,143 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →AbbVie is the lead sponsor of 967 studies on the registry; 132 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will be administered with upadacitinib once daily (QD)
Drug: Upadacitinib
Upadacitinib will be administered oral as tablet
Also known as: ABT-494, RINVOQ
Number of Participants With Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Lead-In Study M16-046 for the UPA/UPA arm or this Study M19-850 DUPI/UPA arm through 30 days following the last dose of upadacitinib.
Time frame: UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days).
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Treatment-emergent adverse events were monitored throughout the study to identify any adverse events of special interest that may indicate a trend or risk to participants. AESIs are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Study M16-046 for the UPA/UPA arm or Study M19-850 for the DUPI/UPA arm through 30 days following the last dose of upadacitinib.
Time frame: UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days).
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Clinical laboratory test values are considered PCI if they meet either the lower-limit or higher-limit PCI criteria defined in the categories below. Percentage of participants with PCI laboratory values are summarized for hematology and chemistry. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline. xULN = Times upper limit of the normal range.
Time frame: From Baseline to 30 days following last dose of study drug (Week 52)
Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator
PCI post-baseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting\], pulse rate \[sitting\], and weight. Only those categories where at least 1 person had a non-PCI value at Baseline and met the PCI criterion at least once during post-baseline are reported. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline.
Time frame: From Baseline to 30 days following last dose of study drug (Week 52)
A total of 475 participants were enrolled at 114 sites located in 22 countries (Australia, Canada, Croatia, Czechia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Taiwan, Ukraine, United Kingdom, and the US).
| Milestone | DUPI 300mg to UPA 30mg | UPA 30mg to UPA 30mg |
|---|---|---|
| Started | 239 | 236 |
| Completed | 214 | 197 |
| Not completed | 25 | 39 |
| Withdrew: Adverse event | 4 | 11 |
| Withdrew: Withdrawal by subject | 9 | 10 |
| Withdrew: Lost to follow-up | 5 | 4 |
| Withdrew: Lack of efficacy | 2 | 10 |
| Withdrew: Other | 5 | 4 |
Treatment-emergent adverse events (TEAEs) are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Lead-In Study M16-046 for the UPA/UPA arm or this Study M19-850 DUPI/UPA arm through 30 days following the last dose of upadacitinib.
| Participants | DUPI 300mg to UPA 30mg | UPA 30mg to UPA 30mg |
|---|---|---|
| Any TEAE | 205 | 223 |
| TESAE | 14 | 17 |
| TEAE leading to discontinuation of study drug | 12 | 18 |
Treatment-emergent adverse events were monitored throughout the study to identify any adverse events of special interest that may indicate a trend or risk to participants. AESIs are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Study M16-046 for the UPA/UPA arm or Study M19-850 for the DUPI/UPA arm through 30 days following the last dose of upadacitinib.
| Participants | DUPI 300mg to UPA 30mg | UPA 30mg to UPA 30mg |
|---|---|---|
| Serious infections | 7 | 8 |
| Opportunistic infection excluding Tuberculosis and Herpes Zoster | 6 | 4 |
| Malignancy | 1 | 0 |
| Non-melanoma skin cancer (NMSC) | 0 | 0 |
| Malignancy excluding NMSC | 1 | 0 |
| Lymphoma | 0 | 0 |
| Hepatic disorder | 19 | 15 |
| Adjudicated gastrointestinal perforations | 0 | 0 |
| Anemia | 7 | 8 |
| Neutropenia | 10 | 8 |
| Lymphopenia | 4 | 5 |
| Herpes zoster | 26 | 25 |
| Creatine phosphokinase (CPK) elevation | 31 | 44 |
| Renal dysfunction | 0 | 0 |
| Active tuberculosis | 0 | 1 |
| Adjudicated MACE | 0 | 0 |
| Adjudicated VTE | 0 | 0 |
Clinical laboratory test values are considered PCI if they meet either the lower-limit or higher-limit PCI criteria defined in the categories below. Percentage of participants with PCI laboratory values are summarized for hematology and chemistry. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline. xULN = Times upper limit of the normal range.
| percentage of participants | DUPI 300mg to UPA 30mg | UPA 30mg to UPA 30mg |
|---|---|---|
| Hemoglobin (G/L): Grade 3 (<80) | 0 | 0.8 |
| Hemoglobin (G/L): Grade 3 or above | 0 | 0.8 |
| Platelets (10^9/L): Grade 3 (25-<50) | 0 | 0.4 |
| Platelets (10^9/L): Grade 4 (<25) | 0 | 0 |
| Platelets (10^9/L): Grade 3 or above | 0 | 0.4 |
| Leukocytes (10^9/L): Grade 3 (1.0-<2.0) | 0 | 1.3 |
| Leukocytes (10^9/L): Grade 4 (<1.0) | 0 | 0 |
| Leukocytes (10^9/L): Grade 3 or above | 0 | 1.3 |
| Neutrophils(10^9/L): Grade 3 (0.5-<1.0) | 2.5 | 3.4 |
| Neutrophils(10^9/L): Grade 4 (<0.5) | 0.4 | 0.4 |
| Neutrophils(10^9/L): Grade 3 or above | 2.9 | 3.8 |
| Lymphocytes(10^9/L): Grade 3 (0.2-<0.5) | 0.8 | 3.4 |
| Lymphocytes(10^9/L): Grade 4 (<0.2) | 0 | 0.4 |
| Lymphocytes(10^9/L): Grade 3 or above | 0.8 | 3.8 |
| Alanine Aminotransferase (U/L): Grade 3 (>5.0-20.0 xULN) | 0.4 | 0.4 |
| Alanine Aminotransferase (U/L): Grade 4 (>20.0 xULN) | 0 | 0 |
| Alanine Aminotransferase (U/L): Grade 3 or above | 0.4 | 0.4 |
| Aspartate Aminotransferase (U/L): Grade 3 (>5.0-20.0 xULN) | 0 | 1.3 |
| Aspartate Aminotransferase (U/L): Grade 4 (>20.0 xULN) | 0 | 0 |
| Aspartate Aminotransferase (U/L): Grade 3 or above | 0 | 1.3 |
| Alkaline Phosphatase (U/L): Grade 3 (>5.0-20.0 xULN) | 0 | 0 |
| Alkaline Phosphatase (U/L): Grade 4 (>20.0 xULN) | 0 | 0 |
| Alkaline Phosphatase (U/L): Grade 3 or above | 0 | 0 |
| Creatine Kinase (U/L): Grade 3 (>5.0-10.0 xULN) | 4.2 | 8.1 |
| Creatine Kinase (U/L): Grade 4 (>10.0 xULN) | 3.8 | 5.1 |
| Creatine Kinase (U/L): Grade 3 or above | 8.0 | 13.1 |
| Creatinine (UMOL/L): Grade 3 (>3.0-6.0 xULN OR >3.0 xBaseline) | 0 | 0.8 |
| Creatinine (UMOL/L): Grade 4 (>6.0 xULN) | 0 | 0.4 |
| Creatinine (UMOL/L): Grade 3 or above | 0 | 1.3 |
| Phosphate (MMOL/L): Grade 3 (0.3-<0.6) | 1.7 | 1.3 |
| Phosphate (MMOL/L): Grade 4 (<0.3) | 0 | 0 |
| Phosphate (MMOL/L): Grade 3 or above | 1.7 | 1.3 |
| Calcium Hyper (MMOL/L): Grade 3 (>3.1-3.4) | 0 | 0.4 |
| Calcium Hyper (MMOL/L): Grade 4 (>3.4) | 0 | 0 |
| Calcium Hyper (MMOL/L): Grade 3 or above | 0 | 0.4 |
| Calcium Hypo (MMOL/L): Grade 3 (1.5-<1.75) | 0 | 0 |
| Calcium Hypo (MMOL/L): Grade 4 (<1.5) | 0 | 0.4 |
| Calcium Hypo (MMOL/L): Grade 3 or above | 0 | 0.4 |
| Sodium Hyper (MMOL/L): Grade 3 (>155-160) | 0.5 | 0 |
| Sodium Hyper (MMOL/L): Grade 4 (>160) | 0 | 0 |
| Sodium Hyper (MMOL/L): Grade 3 or above | 0.5 | 0 |
| Sodium Hypo (MMOL/L): Grade 3 (120-<130) | 0 | 0.4 |
| Sodium Hypo (MMOL/L): Grade 4 (<120) | 0 | 0 |
| Sodium Hypo (MMOL/L): Grade 3 or above | 0 | 0.4 |
| Potassium Hyper (MMOL/L): Grade 3 (>6.0-7.0) | 0 | 0 |
| Potassium Hyper (MMOL/L): Grade 4 (>7.0) | 0 | 0 |
| Potassium Hyper (MMOL/L): Grade 3 or above | 0 | 0 |
| Potassium Hypo (MMOL/L): Grade 3 (2.5-<3.0) | 0 | 0 |
| Potassium Hypo (MMOL/L): Grade 4 (<2.5) | 0 | 0 |
| Potassium Hypo (MMOL/L): Grade 3 or above | 0 | 0 |
| Glucose Hyper (MMOL/L): Grade 3 (>13.9-27.8) | 1.3 | 0.4 |
| Glucose Hyper (MMOL/L): Grade 4 (>27.8) | 0 | 0 |
| Glucose Hyper (MMOL/L): Grade 3 or above | 1.3 | 0.4 |
| Glucose Hypo (MMOL/L): Grade 3 (1.7-<2.2) | 0 | 0 |
| Glucose Hypo (MMOL/L): Grade 4 (<1.7) | 0 | 0 |
| Glucose Hypo (MMOL/L): Grade 3 or above | 0 | 0 |
| Albumin (G/L): Grade 3 (<20) | 0 | 0 |
| Albumin (G/L): Grade 3 or above | 0 | 0 |
| Cholesterol (MMOL/L): Grade 3 (10.34<-12.92) | 1.3 | 0 |
| Cholesterol (MMOL/L): Grade 4 (>12.92) | 0 | 0 |
| Cholesterol (MMOL/L): Grade 3 or above | 1.3 | 0 |
| Triglycerides (MMOL/L): Grade 3 (>5.7-11.4) | 3.4 | 5.1 |
| Triglycerides (MMOL/L): Grade 4 (>11.4) | 0 | 0 |
| Triglycerides (MMOL/L): Grade 3 or above | 3.4 | 5.1 |
PCI post-baseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting\], pulse rate \[sitting\], and weight. Only those categories where at least 1 person had a non-PCI value at Baseline and met the PCI criterion at least once during post-baseline are reported. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline.
| percentage of participants | DUPI 300mg to UPA 30mg | UPA 30mg to UPA 30mg |
|---|---|---|
| Sitting Systolic Blood Pressure (MMHG): ≤90 and ≥20 Decrease | 0.4 | 0.8 |
| Sitting Systolic Blood Pressure (MMHG): ≥160 and ≥20 Increase | 2.5 | 5.5 |
| Sitting Diastolic Blood Pressure (MMHG): ≤50 and ≥10 Decrease | 0.4 | 1.3 |
| Sitting Diastolic Blood Pressure (MMHG): ≥100 and ≥10 Increase | 2.1 | 9.3 |
| Sitting Pulse Rate (BEATS/MIN): ≤50 and ≥15 Decrease | 1.7 | 4.7 |
| Sitting Pulse Rate (BEATS/MIN): ≥120 and ≥15 Increase | 0 | 2.1 |
| Weight (KG): >7% Decrease | 5.5 | 7.6 |
| Weight (KG): >7% Increase | 22.5 | 39.0 |
Collected over All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| UPA 30mg to UPA 30mg | 1/236 (0.4%) | 13/236 (5.5%) | 154/236 (65.3%) |
| DUPI 300mg to UPA 30mg | 0/239 (0%) | 14/239 (5.9%) | 149/239 (62.3%) |
| Total | 1/475 (0.2%) | 27/475 (5.7%) | 303/475 (63.8%) |
| Event | UPA 30mg to UPA 30mg | DUPI 300mg to UPA 30mg | Total |
|---|---|---|---|
| COVID-19 PNEUMONIAInfections and infestations | 3/236 | 0/239 | 3/475 |
| ECZEMA HERPETICUMInfections and infestations | 1/236 | 2/239 | 3/475 |
| UTERINE LEIOMYOMANeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/236 | 2/239 | 2/475 |
| PANCREATITISGastrointestinal disorders | 1/236 | 0/239 | 1/475 |
| FOOD ALLERGYImmune system disorders | 1/236 | 0/239 | 1/475 |
| BONE TUBERCULOSISInfections and infestations | 1/236 | 0/239 | 1/475 |
| BULLOUS IMPETIGOInfections and infestations | 1/236 | 0/239 | 1/475 |
| PILONIDAL DISEASEInfections and infestations | 1/236 | 0/239 | 1/475 |
| PNEUMONIAInfections and infestations | 1/236 | 0/239 | 1/475 |
| HAEMOGLOBIN DECREASEDInvestigations | 1/236 | 0/239 | 1/475 |
| Event | UPA 30mg to UPA 30mg | DUPI 300mg to UPA 30mg | Total |
|---|---|---|---|
| ACNESkin and subcutaneous tissue disorders | 54/236 | 49/239 | 103/475 |
| DERMATITIS ATOPICSkin and subcutaneous tissue disorders | 45/236 | 30/239 | 75/475 |
| BLOOD CREATINE PHOSPHOKINASE INCREASEDInvestigations | 35/236 | 31/239 | 66/475 |
| COVID-19Infections and infestations | 31/236 | 32/239 | 63/475 |
| NASOPHARYNGITISInfections and infestations | 15/236 | 26/239 | 41/475 |
| HERPES ZOSTERInfections and infestations | 19/236 | 25/239 | 44/475 |
| HEADACHENervous system disorders | 15/236 | 14/239 | 29/475 |
| ECZEMASkin and subcutaneous tissue disorders | 14/236 | 13/239 | 27/475 |
| HYPERTENSIONVascular disorders | 14/236 | 4/239 | 18/475 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 12/236 | 14/239 | 26/475 |
The Baseline visit for this study was the Week 24 visit of Parent Study M16-046.
| Age, Continuous(years) | DUPI 300mg to UPA 30mg | UPA 30mg to UPA 30mg | Total |
|---|---|---|---|
| Mean | 35.3 ± 12.90 | 36.1 ± 14.41 | 35.7 ± 13.66 |
| Age, Customized(Participants) | DUPI 300mg to UPA 30mg | UPA 30mg to UPA 30mg | Total |
|---|---|---|---|
| Not Specified — < 40 years | 167 | 156 | 323 |
| Not Specified — ≥ 40 to < 65 years | 66 | 70 | 136 |
| Not Specified — ≥ 65 years | 6 | 10 | 16 |
| Sex: Female, Male(Participants) | DUPI 300mg to UPA 30mg | UPA 30mg to UPA 30mg | Total |
|---|---|---|---|
| Female | 100 | 104 | 204 |
| Male | 139 | 132 | 271 |
| Ethnicity (NIH/OMB)(Participants) | DUPI 300mg to UPA 30mg | UPA 30mg to UPA 30mg | Total |
|---|---|---|---|
| Hispanic or Latino | 17 | 16 | 33 |
| Not Hispanic or Latino | 222 | 220 | 442 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | DUPI 300mg to UPA 30mg | UPA 30mg to UPA 30mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 49 | 46 | 95 |
| Native Hawaiian or Other Pacific Islander | 1 | 2 | 3 |
| Black or African American | 11 | 14 | 25 |
| White | 172 | 170 | 342 |
| More than one race | 5 | 3 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Eczema Area and Severity Index (EASI) Score(score on a scale) | DUPI 300mg to UPA 30mg | UPA 30mg to UPA 30mg | Total |
|---|---|---|---|
| Mean | 3.26 ± 4.172 | 2.51 ± 4.274 | 2.89 ± 4.236 |
| Duration Since AD Diagnosis(years) | DUPI 300mg to UPA 30mg | UPA 30mg to UPA 30mg | Total |
|---|---|---|---|
| Mean | 25.141 ± 13.6369 | 23.938 ± 14.9433 | 24.543 ± 14.2985 |
Showing the first 100 of 116 sites across 22 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Data sharing details ↗ · vivli.org
Ran from Jan 2020 to primary completion in Sep 2023, 43 months.
Results were first posted in Jan 2025, 1 year 3 months after primary completion.
Of 132 industry-sponsored phase 3 interventional studies under Dermatitis, Atopic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 26. This study's 43 months is above that.
Counting every sponsor, half of 139 studies reached it within 18 months; a quarter within 13 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Upadacitinib