CLINICAL TRIALS PROFILE FOR RINVOQ LQ

All Clinical Trials for Rinvoq Lq

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
NCT02706951 ↗	A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)	Active, not recruiting	AbbVie	Phase 3	2016-03-23	The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX. The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.
NCT02782663 ↗	A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease	Active, not recruiting	AbbVie	Phase 2	2016-05-18	This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

Clinical Trial Conditions for Rinvoq Lq

Condition Name

Condition Name for Rinvoq Lq
Intervention	Trials
Rheumatoid Arthritis	8
Atopic Dermatitis	8
Crohn's Disease	3
Ulcerative Colitis (UC)	3

Condition MeSH

Condition MeSH for Rinvoq Lq
Intervention	Trials
Arthritis	10
Dermatitis, Atopic	9
Dermatitis	9
Eczema	9

Clinical Trial Locations for Rinvoq Lq

Trials by Country

Trials by Country for Rinvoq Lq
Location	Trials
United States	731
Japan	330
China	138
Canada	116
Poland	107

Trials by US State

Trials by US State for Rinvoq Lq
Location	Trials
Ohio	31
Florida	30
California	30
Texas	30
Michigan	27

Clinical Trial Progress for Rinvoq Lq

Clinical Trial Phase

Clinical Trial Phase for Rinvoq Lq
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	28
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Rinvoq Lq
Clinical Trial Phase	Trials
Active, not recruiting	15
Not yet recruiting	10
Recruiting	5

Clinical Trial Sponsors for Rinvoq Lq

Sponsor Name

Sponsor Name for Rinvoq Lq
Sponsor	Trials
AbbVie	37
University of Pennsylvania	1
Jeffrey Curtis	1

Sponsor Type

Sponsor Type for Rinvoq Lq
Sponsor	Trials
Industry	41
Other	8

RINVOQ (Upadacitinib): A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

RINVOQ (upadacitinib) is a Janus kinase (JAK) inhibitor that has been making significant strides in the treatment of various autoimmune and inflammatory diseases. This article provides an in-depth look at the clinical trials, market analysis, and future projections for RINVOQ.

Clinical Trials Overview

Rheumatoid Arthritis (RA)

Clinical trials for RINVOQ in RA have shown promising results. In Phase 3 studies, RINVOQ demonstrated efficacy in reducing the signs and symptoms of RA, with a greater proportion of patients achieving an ACR20 response compared to placebo or comparator drugs[3].

• Durable Remission: RINVOQ achieved durable remission and low disease activity rates, with patients maintaining DAS28-CRP <2.6 and DAS28-CRP ≤3.2 at Week 12 or 14, and these effects were sustained up to approximately 5 years[2].
• Primary Endpoints: The co-primary endpoints included the percentage of patients achieving EASI 75 and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 after 16 weeks of treatment, which were met in several studies[1].

Atopic Dermatitis

In the treatment of moderate to severe atopic dermatitis, RINVOQ has shown significant efficacy, particularly in areas difficult to treat such as the head and neck.

• Measure Up 1 and Measure Up 2: These Phase 3 studies demonstrated that RINVOQ achieved optimal treatment targets with combined measures of EASI 90 and WP-NRS 0/1, along with improvements in patients' quality of life measured by DLQI 0/1[1].
• Response Rates: Treatment with RINVOQ led to reduced extent and severity of the disease in 60-80% of patients, compared to 13-16% of patients on placebo[5].

Crohn’s Disease

For moderately to severely active Crohn’s disease, RINVOQ has been effective in improving symptoms and reducing inflammation.

• Clinical Response: After 12 weeks, 40-51% of patients on RINVOQ achieved clinical response, compared to 14-22% on placebo. At 52 weeks, symptoms were gone or almost gone in 36-46% of patients on RINVOQ, compared to 14% on placebo[4].
• Endoscopic Control: RINVOQ achieved significant endoscopic control, with visible mucosal improvement and endoscopic remission at Weeks 12 and 52[4].

Other Indications

RINVOQ has also shown efficacy in psoriatic arthritis, axial spondyloarthritis, and ulcerative colitis.

• Psoriatic Arthritis: RINVOQ was more effective than adalimumab or placebo in reducing symptoms, with 57-71% of patients achieving a reduction in symptoms after 12 weeks[5].
• Axial Spondyloarthritis: RINVOQ reduced symptoms in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis, with 52% and 45% of patients showing improvement, respectively[5].
• Ulcerative Colitis: RINVOQ cleared symptoms and improved inflammation in the bowel lining, with 26-34% of patients achieving clinical remission after 8 weeks, compared to 4-5% on placebo[5].

Market Analysis

Current Market Position

RINVOQ is currently approved for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, atopic dermatitis, Crohn’s disease, and ulcerative colitis. Its efficacy and safety profile have positioned it as a strong competitor in the JAK inhibitor market.

Market Size and Growth

The global JAK inhibitors market is expected to grow significantly, driven by the increasing prevalence of autoimmune diseases and the need for effective treatments. RINVOQ, with its broad range of indications, is poised to capture a substantial share of this growing market.

Competitive Landscape

RINVOQ competes with other JAK inhibitors such as tofacitinib (Xeljanz) and baricitinib (Olumiant). However, its unique dosing regimen and efficacy in various indications have helped it differentiate itself in the market.

Safety and Side Effects

Key Safety Concerns

While RINVOQ has shown significant efficacy, it also comes with important safety considerations.

• Malignancies: There is an increased risk of malignancies, particularly lung cancer, lymphoma, and non-melanoma skin cancer, especially at the 30 mg dose[1][5].
• Infections: RINVOQ can increase the risk of serious infections, including tuberculosis and herpes zoster[5].
• Cardiovascular Risks: There is a potential increased risk of major adverse cardiovascular events (MACE) associated with JAK inhibitors, including RINVOQ[5].

Future Projections

Ongoing and Planned Trials

RINVOQ is being studied in additional Phase 3 clinical trials for conditions such as alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. These trials are expected to further expand its therapeutic scope[1].

Market Expansion

Given its broad efficacy and the growing demand for effective treatments for autoimmune diseases, RINVOQ is projected to see significant market expansion. The drug's ability to treat multiple conditions will likely increase its prescription rates and market share.

Regulatory Approvals

As RINVOQ continues to demonstrate efficacy in new indications, it is expected to receive additional regulatory approvals, further solidifying its position in the market.

Key Takeaways

• Efficacy Across Multiple Indications: RINVOQ has shown significant efficacy in treating various autoimmune and inflammatory diseases, including RA, atopic dermatitis, Crohn’s disease, and others.
• Durable Remission: The drug has demonstrated durable remission and low disease activity rates in long-term studies.
• Market Growth: The global JAK inhibitors market is expected to grow, with RINVOQ poised to capture a substantial share.
• Safety Considerations: While effective, RINVOQ comes with important safety concerns, including increased risks of malignancies and infections.

FAQs

What is RINVOQ used for?

RINVOQ (upadacitinib) is used for the treatment of various autoimmune and inflammatory diseases, including moderate to severe rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, Crohn’s disease, and ulcerative colitis.

What are the key benefits of RINVOQ in clinical trials?

RINVOQ has demonstrated significant efficacy in reducing symptoms and achieving durable remission in various diseases, with a higher proportion of patients achieving clinical response compared to placebo or comparator drugs.

What are the major safety concerns associated with RINVOQ?

Major safety concerns include an increased risk of malignancies, serious infections, and potential cardiovascular risks.

Is RINVOQ approved for use in children?

RINVOQ is approved for use in adolescents aged 12 years and older with moderate to severe atopic dermatitis, but its use in younger children is not currently approved.

What are the ongoing and planned clinical trials for RINVOQ?

RINVOQ is being studied in Phase 3 clinical trials for conditions such as alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.

Sources

1. New Analysis Demonstrates the Efficacy of RINVOQ® (upadacitinib) in Atopic Dermatitis with Varying Degrees of Severity in Head and Neck Involvement. AbbVie News.
2. RINVOQ® (upadacitinib) Efficacy for Rheumatoid Arthritis. Rinvoqhcp.com.
3. Drug Trials Snapshots: RINVOQ. FDA.
4. RINVOQ® (upadacitinib) Efficacy for Crohn's Disease. Rinvoqhcp.com.
5. Rinvoq | European Medicines Agency (EMA). EMA.europa.eu.