CLINICAL TRIALS PROFILE FOR UPADACITINIB

All Clinical Trials for UPADACITINIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02706847 ↗	A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs	Active, not recruiting	AbbVie	Phase 3	2016-03-15	The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of 30 mg once daily (QD) and 15 mg QD upadacitinib versus placebo for the treatment of signs and symptoms of participants with moderately to severely active RA who were on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.
NCT02706873 ↗	A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate	Active, not recruiting	AbbVie	Phase 3	2016-02-23	The objectives of Period 1 were the following: - To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA; - To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA. The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.
NCT02675426 ↗	A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone	Active, not recruiting	AbbVie	Phase 3	2015-12-17	The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.
NCT02629159 ↗	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate	Active, not recruiting	AbbVie	Phase 3	2015-12-01	The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX and who have an inadequate response to MTX.
NCT02365649 ↗	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intoleran	Completed	AbbVie	Phase 2	2015-03-17	To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.
NCT02066389 ↗	A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone	Completed	AbbVie	Phase 2	2014-03-26	The primary objective of the study was to compare the safety and efficacy of multiple doses of upadacitinib versus placebo in adults with moderately to severely active rheumatoid arthritis (RA) on stable background methotrexate therapy who had not shown an adequate response to methotrexate alone.
NCT02049138 ↗	An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Rheumatoid Arthritis Subjects	Completed	AbbVie	Phase 2	2014-01-24	This is a Phase 2, multicenter, open-label extension study in RA subjects. The sub-study is to assess the impact of upadacitinib treatment (15 mg QD and 30 mg QD) with background MTX on immunological responses to Prevnar 13® in RA patients.

Clinical Trial Conditions for UPADACITINIB

Condition Name

Condition Name for UPADACITINIB
Intervention	Trials
Rheumatoid Arthritis	15
Atopic Dermatitis	10
Rheumatoid Arthritis (RA)	4
Crohn's Disease	4

Condition MeSH

Condition MeSH for UPADACITINIB
Intervention	Trials
Arthritis	21
Arthritis, Rheumatoid	17
Eczema	11
Dermatitis, Atopic	11

Clinical Trial Locations for UPADACITINIB

Trials by Country

+

−

Trials by Country for UPADACITINIB
Location	Trials
United States	899
Japan	387
China	150
Canada	143
Poland	142

Trials by US State

+

−

Trials by US State for UPADACITINIB
Location	Trials
Texas	38
Florida	38
California	38
Ohio	36
Illinois	32

Clinical Trial Progress for UPADACITINIB

Clinical Trial Phase

Clinical Trial Phase for UPADACITINIB
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	34
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for UPADACITINIB
Clinical Trial Phase	Trials
Active, not recruiting	21
Not yet recruiting	11
Completed	9

Clinical Trial Sponsors for UPADACITINIB

Sponsor Name

Sponsor Name for UPADACITINIB
Sponsor	Trials
AbbVie	50
Eli Lilly and Company	1
Ottawa Hospital Research Institute	1

Sponsor Type

Sponsor Type for UPADACITINIB
Sponsor	Trials
Industry	54
Other	15

Upadacitinib: Clinical Trials Update, Market Analysis, and Projections

Introduction

Upadacitinib, marketed under the brand name RINVOQ, is a selective Janus kinase (JAK) inhibitor that has been gaining significant attention for its efficacy in treating various autoimmune and inflammatory conditions. Here, we will delve into the latest updates from clinical trials, market analysis, and projections for this promising drug.

Clinical Trials Update

Atopic Dermatitis

Recent clinical trials, including the Measure Up 1, Measure Up 2, and AD Up studies, have demonstrated the efficacy and safety of upadacitinib in adolescents and adults with moderate to severe atopic dermatitis (AD). These phase 3 randomized clinical trials showed sustained efficacy responses through 76 weeks, with a favorable long-term benefit-risk profile[1].

A new post-hoc analysis from the Measure Up 1 and Measure Up 2 studies highlighted the drug's efficacy in patients with varying degrees of head and neck involvement, further solidifying its position as a treatment option for AD[4].

Other Indications

Upadacitinib is also being studied in Phase 3 clinical trials for other conditions such as alopecia areata, giant cell arteritis, and hidradenitis suppurativa. These ongoing trials aim to expand the therapeutic indications of upadacitinib, potentially increasing its market reach[4].

Ulcerative Colitis

In the context of ulcerative colitis (UC), upadacitinib has shown promise in inducing and maintaining clinical remission and response compared to placebo. However, there is a need for more comparative data with other advanced therapies to fully understand its efficacy and safety profile in UC[2].

Safety Profile

Adverse Events

The long-term safety data from the Measure Up trials indicate that the adverse event profile of upadacitinib is consistent with its known safety profile. This includes herpetic infections, creatine kinase elevation, and other events, with no new safety signals observed[1].

Comparative Safety

Drug plans and regulatory bodies have expressed concerns about the safety of upadacitinib relative to other JAK inhibitors, such as tofacitinib, particularly regarding risks of serious infections, malignancy, and thrombosis. These concerns highlight the need for ongoing monitoring and comparison with other treatments[2].

Market Analysis

Current Market Size and Growth

The global upadacitinib market was valued at USD 1.18 billion in 2023 and is projected to reach USD 3.83 billion by 2031, growing at a compound annual growth rate (CAGR) of 18% from 2024 to 2031. This rapid growth is driven by the drug's effectiveness in treating autoimmune conditions like rheumatoid arthritis and the increasing prevalence of these diseases[3].

Market Drivers

Several factors are driving the growth of the upadacitinib market:

• Rising Prevalence of Autoimmune Diseases: The increasing incidence of conditions such as rheumatoid arthritis and ulcerative colitis is creating a higher demand for effective treatments.
• Advances in Biopharmaceutical Research: Improved understanding of immune system dysregulation and inflammatory pathways supports the development of specific JAK inhibitors like upadacitinib.
• Regulatory Approvals: Positive regulatory approvals in various countries have facilitated market expansion.
• Patient Demand: There is a growing demand for biologic medicines and customized treatment alternatives, which upadacitinib addresses[3].

Market Projections

Sales Guidance

AbbVie, the manufacturer of upadacitinib, has confirmed revenue guidance of greater than $7.5 billion in risk-adjusted sales for RINVOQ in 2025. This projection is supported by higher anticipated sales in international markets and global sales in conditions like Crohn's disease[5].

Competitive Landscape

The market for upadacitinib is also influenced by the presence of other treatments, including biologics and small-molecule drugs. The upcoming availability of generic tofacitinib, another JAK inhibitor, may impact the pricing and market share of upadacitinib. However, upadacitinib's unique efficacy profile and expanding therapeutic indications are expected to maintain its competitive edge[2][3].

Key Takeaways

• Clinical Efficacy: Upadacitinib has demonstrated sustained efficacy in treating moderate to severe atopic dermatitis and other autoimmune conditions.
• Safety Profile: The drug's long-term safety profile is consistent with known adverse events, but ongoing monitoring is necessary.
• Market Growth: The global upadacitinib market is expected to grow significantly, driven by the rising prevalence of autoimmune diseases and advances in biopharmaceutical research.
• Sales Projections: AbbVie projects over $7.5 billion in risk-adjusted sales for RINVOQ in 2025, reflecting strong market demand.

FAQs

What is upadacitinib used for?

Upadacitinib is used to treat various autoimmune and inflammatory conditions, including moderate to severe atopic dermatitis, rheumatoid arthritis, and ulcerative colitis.

What are the key findings from the Measure Up trials?

The Measure Up trials demonstrated the efficacy and safety of upadacitinib in adolescents and adults with moderate to severe atopic dermatitis, showing sustained efficacy responses through 76 weeks.

What are the safety concerns associated with upadacitinib?

Safety concerns include the risk of serious infections, malignancy, and thrombosis, which are being closely monitored and compared with other JAK inhibitors.

How is the market for upadacitinib expected to grow?

The global upadacitinib market is projected to grow at a CAGR of 18% from 2024 to 2031, reaching USD 3.83 billion by 2031.

What is AbbVie's sales guidance for RINVOQ in 2025?

AbbVie expects risk-adjusted sales of greater than $7.5 billion for RINVOQ in 2025, driven by higher sales in international markets and other indications.

Sources

1. Upadacitinib in Adolescents With Moderate to Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatology.
2. Pharmacoeconomic Review - Upadacitinib (Rinvoq). NCBI Bookshelf.
3. Global Upadacitinib Market Size, Scope And Forecast Report. Market Research Intellect.
4. New Analysis Demonstrates the Efficacy of RINVOQ® (upadacitinib) in Atopic Dermatitis. AbbVie News.
5. AbbVie Confirms Guidance of Greater Than $15 Billion in Combined Risk-Adjusted Sales for Rinvoq and Skyrizi in 2025. AbbVie News.