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

Expanded Access to Upadacitinib

Conditions: Atopic Dermatitis (AD)

First Posted Date: 2019-11-12

Last Posted Date: 2021-08-09

Lead Sponsor: AbbVie

Registration Number: NCT04159597

A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

Phase 2

Completed

Conditions: Systemic Lupus Erythematosus (SLE)

Interventions: Drug: Placebo for elsubrutinib
Drug: Elsubrutinib
Drug: Placebo for upadacitinib
Drug: Upadacitinib

First Posted Date: 2019-06-07

Last Posted Date: 2023-07-21

Lead Sponsor: AbbVie

Target Recruit Count: 341

Registration Number: NCT03978520

Locations: 🇺🇸
Medvin Clinical Research /ID# 211996, Tujunga, California, United States
🇺🇸
Arizona Arthritis & Rheumatology Research, PLLC /ID# 214522, Mesa, Arizona, United States
🇨🇳
Shanghai Changhai Hospital /ID# 211819, Shanghai, Shanghai, China

and more 157 locations

A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib

Phase 2

Terminated

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: Elsubrutinib
Drug: Placebo for upadacitinib
Drug: Placebo for elsubrutinib
Drug: Upadacitinib

First Posted Date: 2019-01-30

Last Posted Date: 2021-09-16

Lead Sponsor: AbbVie

Target Recruit Count: 97

Registration Number: NCT03823378

Locations: 🇵🇱
ClinicMed Daniluk, Nowak Sp.j. /ID# 212578, Białystok, Podlaskie, Poland
🇭🇺
CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 208188, Szekesfehervar, Hungary
🇵🇱
NBR Polska /ID# 209904, Warsaw, Mazowieckie, Poland

and more 27 locations

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

Phase 1

Active, not recruiting

Conditions: Juvenile Idiopathic Arthritis (JIA)

Interventions: Drug: Upadacitinib

First Posted Date: 2018-10-30

Last Posted Date: 2024-06-20

Lead Sponsor: AbbVie

Target Recruit Count: 122

Registration Number: NCT03725007

Locations: 🇺🇸
Cincinnati Childrens Hospital Medical Center /ID# 209697, Cincinnati, Ohio, United States
🇵🇷
Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406, Bayamon, Puerto Rico
🇵🇷
Mindful Medical Research /ID# 204488, San Juan, Puerto Rico

and more 32 locations

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

Phase 3

Active, not recruiting

Conditions: Giant Cell Arteritis (GCA)

Interventions: Drug: Upadacitinib
Drug: Corticosteroid (CS)
Other: Placebo

First Posted Date: 2018-10-30

Last Posted Date: 2024-02-23

Lead Sponsor: AbbVie

Target Recruit Count: 429

Registration Number: NCT03725202

Locations: 🇺🇸
University of Vermont Medical Center /ID# 211179, Burlington, Vermont, United States
🇺🇸
Omega Research Group /ID# 201903, Orlando, Florida, United States
🇺🇸
IRIS Research and Development, LLC /ID# 169406, Plantation, Florida, United States

and more 169 locations

A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis

Phase 2

Completed

Conditions: Rheumatoid Arthritis (RA)

Interventions: Drug: Elsubrutinib
Drug: Placebo for elsubrutinib
Drug: Placebo for upadacitinib
Drug: Upadacitinib

First Posted Date: 2018-09-25

Last Posted Date: 2021-05-03

Lead Sponsor: AbbVie

Target Recruit Count: 242

Registration Number: NCT03682705

Locations: 🇺🇸
Tekton Research, Inc. /ID# 167475, Austin, Texas, United States
🇺🇸
Institute of Arthritis Researc /ID# 170694, Idaho Falls, Idaho, United States
🇺🇸
DM Clinical Research /ID# 167444, Tomball, Texas, United States

and more 112 locations

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

Phase 3

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: Upadacitinib
Drug: Topical Corticosteroids (TCS)
Drug: Placebo for upadacitinib

First Posted Date: 2018-09-07

Last Posted Date: 2023-03-01

Lead Sponsor: AbbVie

Target Recruit Count: 272

Registration Number: NCT03661138

Locations: 🇯🇵
Fukuyama City Hospital /ID# 206761, Fukuyama-shi, Hiroshima, Japan
🇯🇵
Nagoya City University Hospital /ID# 207566, Nagoya shi, Aichi, Japan
🇯🇵
Central Clinic /ID# 206558, Nagoya-shi, Aichi, Japan

and more 40 locations

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

Phase 3

Completed

Conditions: Ulcerative Colitis (UC)

Interventions: Drug: Placebo
Drug: Upadacitinib

First Posted Date: 2018-08-31

Last Posted Date: 2022-03-02

Lead Sponsor: AbbVie

Target Recruit Count: 522

Registration Number: NCT03653026

Locations: 🇺🇸
TLC Clinical Research Inc /ID# 216831, Los Angeles, California, United States
🇺🇸
Universal Axon Clinical Research /ID# 213462, Doral, Florida, United States
🇺🇸
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 205314, Los Angeles, California, United States

and more 376 locations

A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

Phase 3

Active, not recruiting

Conditions: Atopic Dermatitis

Interventions: Drug: Placebo for Upadacitinib
Drug: Upadacitinib

First Posted Date: 2018-07-31

Last Posted Date: 2024-03-05

Lead Sponsor: AbbVie

Target Recruit Count: 912

Registration Number: NCT03607422

Locations: 🇺🇸
Dermatology Treatment and Research Center, PA /ID# 205473, Dallas, Texas, United States
🇺🇸
Arkansas Research Trials /ID# 218469, North Little Rock, Arkansas, United States
🇺🇸
Floridian Clinical Research /ID# 207433, Miami Lakes, Florida, United States

and more 193 locations

Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

Phase 3

Active, not recruiting

Conditions: Atopic Dermatitis

Interventions: Drug: Placebo for Upadacitinib
Drug: Upadacitinib

First Posted Date: 2018-06-26

Last Posted Date: 2024-03-05

Lead Sponsor: AbbVie

Target Recruit Count: 912

Registration Number: NCT03569293

Locations: 🇺🇸
Massachusetts General Hospital /ID# 200474, Boston, Massachusetts, United States
🇺🇸
Dawes Fretzin, LLC /ID# 200366, Indianapolis, Indiana, United States
🇹🇷
Erciyes University Medical Fac /ID# 204098, Melikgazi, Kayseri, Turkey

and more 177 locations

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