Upadacitinib

Generic Name: Upadacitinib

Brand Names: Rinvoq

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₉F_₃N_₆O

CAS Number: 1310726-60-3

Unique Ingredient Identifier: 4RA0KN46E0

Background: Upadacitinib is an oral Janus kinase (JAK)1-selective inhibitor and a disease-modifying antirheumatic drug (DMARD) used in the treatment of rheumatoid arthritis to slow down disease progression. Rheumatoid arthritis is a chronic autoimmune inflammatory disease affecting the peripheral joints. It is characterized by synovial inflammation and hyperplasia, auto...

Indication: Upadacitinib is indicated for the treatment of moderately to severely active rheumatoid arthritis or active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as TNF blockers. In Europe, upadacitinib may be used as monotherapy or in combination with met...

Associated Conditions: Ankylosing Spondylitis (AS), Moderately to Severely Active Rheumatoid Arthritis, Moderately to Severely Active Ulcerative Colitis, Severe Atopic Dermatitis, Active Ankylosing spondylitis, Active Non-radiographic Axial Spondyloarthritis, Active Psoriatic arthritis, Moderate, active Crohn´s Disease, Moderate, refractory Atopic dermatitis, Refractory, severe Atopic Dermatitis, Severe, active Crohn´s Disease

Associated Therapies: -

Clinical Trials

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Phase 3

Conditions: Atopic Dermatitis

Interventions: Drug: Placebo
Drug: Topical corticosteroids (TCS)
Drug: Upadacitinib

First Posted Date: 2018-06-26

Last Posted Date: 2024-04-12

Lead Sponsor: AbbVie

Target Recruit Count: 1500

Registration Number: NCT03568318

Locations: 🇺🇸
University of Pittsburgh MC /ID# 206057, Pittsburgh, Pennsylvania, United States
🇨🇦
Kirk Barber Research, CA /ID# 200329, Calgary, Alberta, Canada
🇧🇪
IMTR - Grand Hopital de Charleroi /ID# 202029, Loverval, Belgium

and more 190 locations

Molecular Signatures in Inflammatory Skin Disease

Recruiting

Conditions: Atopic Dermatitis
Psoriasis

Interventions: Drug: Ustekinumab
Drug: Brodalumab
Drug: Ixekizumab
Drug: Baricitinib
Drug: Infliximab
Drug: Secukinumab
Drug: Dupilumab
Drug: Tralokinumab
Drug: Abrocitinib
Drug: Upadacitinib

First Posted Date: 2017-11-30

Last Posted Date: 2024-12-04

Lead Sponsor: Prof. Dr. Stephan Weidinger

Target Recruit Count: 300

Registration Number: NCT03358693

Locations: 🇩🇪
Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel, Kiel, Germany

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Phase 3

Active, not recruiting

Conditions: Crohn's Disease

Interventions: Drug: Placebo for Upadacitinib
Drug: Upadacitinib

First Posted Date: 2017-11-17

Last Posted Date: 2024-06-17

Lead Sponsor: AbbVie

Target Recruit Count: 747

Registration Number: NCT03345823

Locations: 🇺🇸
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170161, Dallas, Texas, United States
🇺🇸
Duplicate_Rush University Medical Center /ID# 165470, Chicago, Illinois, United States
🇺🇸
University of Washington /ID# 164646, Seattle, Washington, United States

and more 463 locations

A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

Phase 3

Completed

Conditions: Crohn's Disease

Interventions: Drug: Upadacitinib
Drug: Placebo for Upadacitinib

First Posted Date: 2017-11-17

Last Posted Date: 2022-11-23

Lead Sponsor: AbbVie

Target Recruit Count: 526

Registration Number: NCT03345849

Locations: 🇦🇺
Fiona Stanley Hospital /ID# 171513, Murdoch, Western Australia, Australia
🇺🇸
Velocity Clinical Research - Salt Lake City /ID# 166076, West Jordan, Utah, United States
🇺🇸
Rush University Medical Center /ID# 165497, Chicago, Illinois, United States

and more 429 locations

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Phase 3

Completed

Conditions: Crohn's Disease

Interventions: Drug: Matching Placebo for Upadacitinib
Drug: Upadacitinib

First Posted Date: 2017-11-17

Last Posted Date: 2022-08-15

Lead Sponsor: AbbVie

Target Recruit Count: 624

Registration Number: NCT03345836

Locations: 🇦🇷
Cardio Alem /ID# 211284, San Isidro, Buenos Aires, Argentina
🇺🇸
Facey Medical Foundation /ID# 203137, Mission Hills, California, United States
🇺🇸
CB Flock Research Corporation /ID# 166220, Mobile, Alabama, United States

and more 425 locations

A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis

Phase 2

Completed

Conditions: Ankylosing Spondylitis (AS)

Interventions: Drug: Upadacitinib
Drug: Placebo

First Posted Date: 2017-06-07

Last Posted Date: 2023-03-07

Lead Sponsor: AbbVie

Target Recruit Count: 187

Registration Number: NCT03178487

Locations: 🇸🇪
Reumatologkliniken /ID# 165713, Vaesteras, Sweden
🇺🇸
Bay Area Arthritis and Osteo /ID# 165023, Brandon, Florida, United States
🇺🇸
St. Lukes Clinic /ID# 165827, Meridian, Idaho, United States

and more 98 locations

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

Phase 3

Completed

Conditions: Psoriatic Arthritis

Interventions: Drug: Upadacitinib
Drug: Adalimumab
Drug: Placebo to Upadacitinib
Drug: Placebo to Adalimumab

First Posted Date: 2017-04-07

Last Posted Date: 2024-10-01

Lead Sponsor: AbbVie

Target Recruit Count: 1705

Registration Number: NCT03104400

Locations: 🇺🇸
Great Lakes Clinical Trials /ID# 163435, Chicago, Illinois, United States
🇨🇳
1st Aff Hosp of Bengbu Medical College /ID# 201021, Bengbu, Anhui, China
🇨🇳
The First Affiliated Hospital of Shantou University Medical College /ID# 203371, Shantou, Guangdong, China

and more 342 locations

A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs

Phase 3

Completed

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion)
Drug: Abatacept
Drug: Upadacitinib
Drug: Placebo for upadacitinib

First Posted Date: 2017-03-22

Last Posted Date: 2024-07-18

Lead Sponsor: AbbVie

Target Recruit Count: 657

Registration Number: NCT03086343

Locations: 🇺🇸
SunValley Arthritis Center, Lt /ID# 154558, Peoria, Arizona, United States
🇺🇸
AZ Arthritis & Rheum Research /ID# 156539, Sun City, Arizona, United States
🇺🇸
CHI St. Vincent Medical Group /ID# 154561, Hot Springs, Arkansas, United States

and more 158 locations

A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)

Phase 3

Completed

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: Upadacitinib
Drug: Placebo

First Posted Date: 2016-11-04

Last Posted Date: 2021-09-27

Lead Sponsor: AbbVie

Target Recruit Count: 338

Registration Number: NCT02955212

Locations: 🇧🇷
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 152964, Curitiba, Parana, Brazil
🇰🇷
Kyungpook National Univ Hosp /ID# 166919, Daegu, Daegu Gwang Yeogsi, Korea, Republic of
🇨🇳
Anhui Provincial Hospital /ID# 161117, Hefei, Anhui, China

and more 40 locations

A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis

Phase 2

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: Upadacitinib
Drug: Placebo

First Posted Date: 2016-10-05

Last Posted Date: 2020-07-16

Lead Sponsor: AbbVie

Target Recruit Count: 167

Registration Number: NCT02925117

Locations: 🇺🇸
Advanced Medical Research /ID# 154516, Sandy Springs, Georgia, United States
🇺🇸
ForCare Clinical Research /ID# 157974, Tampa, Florida, United States
🇺🇸
DermAssociates /ID# 153584, Rockville, Maryland, United States

and more 31 locations

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