CLINICAL TRIALS PROFILE FOR SKYRIZI

All Clinical Trials for SKYRIZI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02684357 ↗	BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis	Completed	Boehringer Ingelheim	Phase 3	2016-03-01	This is a randomized double blind, double dummy, placebo and active comparator controlled, parallel design study that is being performed to assess the safety and efficacy of risankizumab (BI 655066) to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.
NCT02672852 ↗	BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment	Completed	Boehringer Ingelheim	Phase 3	2016-02-29	This was a multinational, multicenter, randomized, double-blind, placebo controlled study with randomized withdrawal and retreatment, evaluating the safety and efficacy of risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque psoriasis.
NCT02672852 ↗	BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment	Completed	AbbVie	Phase 3	2016-02-29	This was a multinational, multicenter, randomized, double-blind, placebo controlled study with randomized withdrawal and retreatment, evaluating the safety and efficacy of risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque psoriasis.
NCT02203851 ↗	Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis	Completed	Boehringer Ingelheim	Phase 2	2014-11-20	The primary objective of Study M16-009 was to investigate the safety of risankizumab in participants with moderate to severe chronic plaque psoriasis who were receiving long-term treatment. Additional study objectives were to further investigate the long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of risankizumab.
NCT02203851 ↗	Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis	Completed	AbbVie	Phase 2	2014-11-20	The primary objective of Study M16-009 was to investigate the safety of risankizumab in participants with moderate to severe chronic plaque psoriasis who were receiving long-term treatment. Additional study objectives were to further investigate the long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of risankizumab.
NCT02047110 ↗	BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)	Completed	Boehringer Ingelheim	Phase 2	2014-01-28	The overall purpose of the trial is to assess the clinical efficacy of three different subcutaneous doses of BI 655066 (risankizumab) in adult patients with AS, in order to provide clinical proof of concept and to select dose (s) for confirmatory clinical trials.
NCT02047110 ↗	BI 655066 (Risankizumab) Proof of Concept Dose Finding Study in Ankylosing Spondylitis (AS)	Completed	AbbVie	Phase 2	2014-01-28	The overall purpose of the trial is to assess the clinical efficacy of three different subcutaneous doses of BI 655066 (risankizumab) in adult patients with AS, in order to provide clinical proof of concept and to select dose (s) for confirmatory clinical trials.

Clinical Trial Conditions for SKYRIZI

Condition Name

Condition Name for SKYRIZI
Intervention	Trials
Psoriasis	15
Crohn's Disease	6
Healthy Volunteers	6
Arthritis, Psoriatic	2

Condition MeSH

Condition MeSH for SKYRIZI
Intervention	Trials
Psoriasis	18
Crohn Disease	7
Arthritis, Psoriatic	3
Arthritis	3

Clinical Trial Locations for SKYRIZI

Trials by Country

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Trials by Country for SKYRIZI
Location	Trials
United States	402
Japan	102
Canada	72
Germany	72
Italy	58

Trials by US State

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−

Trials by US State for SKYRIZI
Location	Trials
Illinois	23
California	23
Texas	22
Florida	22
New York	17

Clinical Trial Progress for SKYRIZI

Clinical Trial Phase

Clinical Trial Phase for SKYRIZI
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	20
Phase 2	5

Clinical Trial Status

Clinical Trial Status for SKYRIZI
Clinical Trial Phase	Trials
Completed	18
Recruiting	11
Not yet recruiting	3

Clinical Trial Sponsors for SKYRIZI

Sponsor Name

Sponsor Name for SKYRIZI
Sponsor	Trials
AbbVie	34
Boehringer Ingelheim	7
Istituto Clinico Humanitas	1

Sponsor Type

Sponsor Type for SKYRIZI
Sponsor	Trials
Industry	42
Other	7

SKYRIZI: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to SKYRIZI

SKYRIZI, also known as risankizumab, is a humanized IgG1 monoclonal antibody developed by AbbVie. It targets the inflammatory IL-23 cytokine, blocking its interaction with its corresponding receptor and thereby dampening the inflammation process. This mechanism makes SKYRIZI effective in treating various immune-mediated diseases, including ulcerative colitis, plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

Clinical Trials for Ulcerative Colitis

The approval of SKYRIZI for ulcerative colitis is backed by robust clinical trial data from the Phase III INSPIRE and COMMAND studies.

INSPIRE Study

In the INSPIRE study, patients treated with intravenous SKYRIZI showed significant clinical remission rates. At 12 weeks, 20% of patients treated with SKYRIZI achieved clinical remission, as determined by the Adapted Mayo Score, compared to 6% in the placebo group. Additionally, 36% of patients treated with SKYRIZI achieved endoscopic improvement at week 12, versus 12.1% in the placebo group[1][4].

COMMAND Study

The COMMAND study evaluated the efficacy of subcutaneous SKYRIZI in maintaining clinical remission. The study found that 40% and 38% of patients treated with 180 mg and 360 mg of SKYRIZI, respectively, achieved clinical remission at 52 weeks, compared to 25% in the induction-only control group. Furthermore, 51% of patients treated with SKYRIZI 180 mg and 48% treated with SKYRIZI 360 mg achieved endoscopic improvement at week 52, versus 32% in the induction-only control group[1][4].

Regulatory Approvals

SKYRIZI has received significant regulatory approvals in recent times:

• European Union: The European Commission approved SKYRIZI for the treatment of adults with moderately to severely active ulcerative colitis in July 2024. This approval is limited to patients who have had an inadequate response to prior conventional or biologic therapies or have lost response to, or are intolerant of, these treatments[1].
• United States: The FDA approved SKYRIZI for ulcerative colitis in June 2024, marking its fourth indication in the U.S.[4].

Market Analysis and Projections

Current Market Performance

SKYRIZI has been performing strongly in the market, particularly in the psoriasis segment. In Q2 2024, Skyrizi's sales grew by almost 45% year-over-year to $2.7 billion, contributing significantly to AbbVie's revenue[1].

Sales Projections

AbbVie has adjusted its sales projections for SKYRIZI and Rinvoq, another key immunology drug. For 2025, AbbVie expects SKYRIZI to generate more than $7.5 billion in sales, matching the projected sales for Rinvoq. The combined sales of these two drugs are expected to exceed $15 billion in 2025[2][5].

Global Market Forecast

The market forecast for SKYRIZI in ulcerative colitis is promising. A detailed market assessment report predicts significant growth in the seven major markets (the United States, EU4, the United Kingdom, and Japan) from 2024 to 2032. The report highlights that extensive research and increased healthcare spending will expand the market size, allowing drug manufacturers to penetrate deeper into the market[3].

Competitive Landscape

SKYRIZI faces competition from other emerging therapies for ulcerative colitis. However, its strong clinical trial data and regulatory approvals position it as a leading treatment option. AbbVie's strategy to leverage SKYRIZI and Rinvoq to mitigate the impact of Humira's patent cliff is expected to drive growth and maintain market dominance[2][3].

Impact of Humira’s Patent Cliff

Humira, AbbVie's blockbuster drug, is facing biosimilar competition, which has led to a significant drop in sales. In Q2 2024, Humira's sales dropped by almost 30%. However, AbbVie's overall revenue still beat analysts’ expectations due to the strong performance of SKYRIZI and Rinvoq. These drugs are expected to cover all of Humira's indications plus atopic dermatitis, ensuring sustained revenue growth for AbbVie[1][2].

Key Takeaways

• Clinical Efficacy: SKYRIZI has demonstrated high remission rates and significant mucosal healing in clinical trials for ulcerative colitis.
• Regulatory Approvals: Approved in the EU and U.S. for ulcerative colitis, with additional indications for psoriasis, psoriatic arthritis, and Crohn’s disease.
• Market Performance: Strong sales growth, with projected sales of over $7.5 billion in 2025.
• Market Forecast: Expected to grow significantly in the seven major markets from 2024 to 2032.
• Competitive Landscape: Faces competition but remains a leading treatment option due to its clinical trial data and regulatory approvals.

FAQs

What is SKYRIZI and how does it work?

SKYRIZI is a humanized IgG1 monoclonal antibody that targets the inflammatory IL-23 cytokine, blocking its interaction with its corresponding receptor and thereby reducing inflammation.

What are the approved indications for SKYRIZI?

SKYRIZI is approved for the treatment of adults with moderately to severely active ulcerative colitis, plaque psoriasis, psoriatic arthritis, and Crohn’s disease.

What were the key findings from the INSPIRE and COMMAND clinical trials?

The INSPIRE study showed that 20% of patients treated with SKYRIZI achieved clinical remission at 12 weeks, and the COMMAND study found that 40% and 38% of patients treated with SKYRIZI achieved clinical remission at 52 weeks.

How does SKYRIZI’s market performance impact AbbVie’s revenue?

SKYRIZI’s strong sales growth, along with Rinvoq, is expected to help AbbVie mitigate the revenue loss from Humira’s patent cliff, with combined sales projected to exceed $15 billion in 2025.

What is the forecasted market scenario for SKYRIZI in ulcerative colitis?

The market is expected to grow significantly from 2024 to 2032, driven by extensive research, increased healthcare spending, and strong clinical trial data.

Sources

1. BioSpace: AbbVie's Skyrizi Wins EU Nod for Ulcerative Colitis, Helps to Weather Humira Patent Cliff.
2. FiercePharma: AbbVie adjusts 2025 individual sales projections for Rinvoq, Skyrizi, but not their combined total.
3. MarketResearch.com: SKYRIZI Emerging Drug Insight and Market Forecast – 2032.
4. Managed Healthcare Executive: FDA Expands Skyrizi's Indications to Include Ulcerative Colitis.
5. PR Newswire: AbbVie Confirms Guidance of Greater Than $15 Billion in Combined Risk-Adjusted Sales for Rinvoq and Skyrizi in 2025.