Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT04195698|
Recruitment Status : Active, not recruiting
First Posted : December 12, 2019
Last Update Posted : September 2, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Upadacitinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||485 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3b, Open-Label Treatment Extension Study of Upadacitinib For the Treatment of Adult Subjects With Moderate to Severe Atopic Dermatitis Who Completed Treatment in Study M16-046|
|Actual Study Start Date :||January 15, 2020|
|Estimated Primary Completion Date :||March 2, 2023|
|Estimated Study Completion Date :||March 2, 2023|
Participants will be administered with upadacitinib once daily (QD)
Upadacitinib will be administered oral as tablet
- Number of Participants With Adverse Events [ Time Frame: From Baseline to 30 days following last dose of study drug (Week 52) ]An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195698
|Study Director:||ABBVIE INC.||AbbVie|