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

Official Summary

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.

Eligibility Requirements

• Minimum Age: 18 Years
• Maximum Age: 75 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 475 participants

Study Arms

• Upadacitinib (EXPERIMENTAL)
  Participants will be administered with upadacitinib once daily (QD)

Interventions

• DRUG: Upadacitinib — Upadacitinib will be administered oral as tablet

Primary Outcomes

• Number of Participants With Treatment-Emergent Adverse Events (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) (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 (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 (From Baseline to 30 days following last dose of study drug (Week 52))

Eligibility Criteria

Inclusion Criteria:

* Participants should have successfully completed treatment in the M16-046 study, without meeting any permanent discontinuation criteria.
* Participant is judged to be in general good health (other than AD) as determined by the Principal Investigator and remains eligible as per the criteria for the study M16-046 to continue treatment in the long term extension study.

Exclusion Criteria:

* Requirement of prohibited medications during the study treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
* Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Trial Locations

• University of Arkansas for Medical Sciences /ID# 221021, Little Rock, Arkansas, United States
• Duplicate_First OC Dermatology Research Inc /ID# 218619, Fountain Valley, California, United States
• UCSF Fresno /ID# 218453, Fresno, California, United States
• California Allergy and Asthma Medical Group /ID# 218635, Los Angeles, California, United States
• Dermatology Research Associates /ID# 218637, Los Angeles, California, United States
• Dermatology Clinical Trials /ID# 218627, Newport Beach, California, United States
• Duplicate_UC Davis Health /ID# 218582, Sacramento, California, United States
• Ucsd /Id# 218629, San Diego, California, United States
• Clinical Science Institute /ID# 218632, Santa Monica, California, United States
• Miami Dermatology and Laser Institute /ID# 218664, Miami, Florida, United States
• ...and 10 more locations

Study Officials

• ABBVIE INC. — STUDY_DIRECTOR
  AbbVie

More Atopic Dermatitis Trials

View all Atopic Dermatitis clinical trials