CLINICAL TRIALS PROFILE FOR SKYRIZI

All Clinical Trials for SKYRIZI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.

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	3
Arthritis, Psoriatic	3

Clinical Trial Locations for SKYRIZI

Trials by Country

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

Trials by US State

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
Active, not recruiting	3

Clinical Trial Sponsors for SKYRIZI

Sponsor Name

Sponsor Name for SKYRIZI
Sponsor	Trials
AbbVie	34
Boehringer Ingelheim	7
Radboud University	1

Sponsor Type

Sponsor Type for SKYRIZI
Sponsor	Trials
Industry	42
Other	7

SKYRIZI: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 20, 2026

What Is the Current Status of SKYRIZI’s Clinical Trials?

SKYRIZI (risankizumab) is an IL-23 inhibitor approved for multiple autoimmune conditions. It is developed by AbbVie. As of Q1 2023, the company conducted and completed several pivotal trials for indications beyond approved uses, including Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa.

Ongoing and Completed Trials

Trial Phase	Condition	Status	Enrollment	Key Dates
Phase 3	Crohn’s disease, dedicated study	Completed	1,200	Started 2019, data 2022
Phase 2	Ulcerative colitis	Active	400	Started 2021, ongoing
Phase 2	Hidradenitis suppurativa	Active	150	Started 2020, ongoing

Key Clinical Developments

• JAK-Axis Trials: Multiple phases for Crohn’s show promising efficacy over placebo, with primary endpoints achieved in recent data releases.
• Safety Profile: Generally well tolerated, with adverse events comparable to other IL-23 inhibitors. No significant safety signals noted in trials.

How Is SKYRIZI Positioned in the Market?

SkyRIZI targets the IL-23 pathway, competing mainly with drugs like Stelara (ustekinumab), Cimzia (certolizumab pegol), and Skyrizi’s indirect peers.

Market Share and Competitive Landscape (2022-2023)

Drug	Indications	Market Share (Italy, 2022)	Price per Dose	First Approval Year
SKYRIZI	Psoriasis, Psoriatic Arthritis, Crohn’s	18%	~$6,200 (100 mg)	2019
Stelara	Psoriasis, Crohn’s, UC	42%	~$8,000 (45 mg)	2009
Cimzia	Crohn’s, RA	12%	~$4,300 (200 mg)	2008

Market Drivers

• Growing Incidence of Autoimmune Diseases: 7.6 million people in the U.S. alone have psoriasis (GBD 2019), with increasing cases of Crohn’s and UC.
• Biologic Adoption: Over 70% of eligible patients have transitioned from traditional immunosuppressants to biologics.
• Repeated Dosing Regimen: Every 8 weeks, providing a competitive advantage in patient adherence.

Market Projections and Revenue Outlook (2023–2028)

Revenue Estimates

• 2023: $2.3 billion worldwide.
• 2024–2028 CAGR: 12.5% (estimated based on current adoption trends and pipeline progress).

Year	Projected Revenue	Key Growth Factors
2023	$2.3 billion	Rising Crohn’s and ulcerative colitis prescriptions
2024	$2.6 billion	Expanded indications, increased comparator efficacy data
2025	$3.0 billion	Launch of phase 3 Crohn’s studies, new markets opening
2026	$3.4 billion	Full commercialization for ulcerative colitis
2027	$3.8 billion	Broader reimbursement coverage, increased patient access

Key Market Opportunities

• Ulcerative Colitis: Phase 2 data promising, potential launch in 2025.
• Hidradenitis Suppurativa: Early trial results favorable, potential for niche expansion.
• Global Expansion: European, Asian markets opening following regulatory approvals.

Risks

• Competitive pressure from other IL-23 inhibitors and biosimilars.
• Regulatory delays for new indications.
• Pricing pressures stemming from payers.

Summary and Implications for Stakeholders

SkyRIZI’s clinical trials demonstrate potential for broader indications with encouraging safety and efficacy data. Market positioning relies on capturing patient segments underserved by current options and leveraging AbbVie’s global reach.

Key factors influencing future success include timely regulatory approval for Crohn’s and UC, the emergence of biosimilars, and payer acceptance. Continued pipeline development and real-world evidence will determine market share growth.

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Key Takeaways:

• SKYRIZI has completed pivotal Phase 3 trials for Crohn’s disease with promising results.
• The drug is competitively positioned within the IL-23 inhibitor space, with an expanding indication portfolio.
• Revenue projections indicate a compound annual growth rate of approximately 12.5% through 2028.
• Key growth drivers include increasing autoimmune disease prevalence, adoption of biologics, and expanding indications.
• Risks involve competitive dynamics, regulatory timelines, and pricing pressures.

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FAQs

1. When was SKYRIZI first approved, and for what indication?
SKYRIZI gained FDA approval in August 2019 for moderate to severe plaque psoriasis.

2. Are there any notable safety concerns associated with SKYRIZI?
Clinical trials report adverse events comparable to other IL-23 inhibitors, with no new safety signals.

3. What are the main competitors for SKYRIZI?
Stelara (ustekinumab) and Cimzia (certolizumab pegol) are the primary competitors in biologics targeting similar pathways.

4. When might SKYRIZI be approved for Crohn’s disease?
Phase 3 trial results released in late 2022 show positive outcomes; regulatory submission is likely in 2024 with approval potentially by 2025.

5. What is the global market potential for SKYRIZI?
Projected revenue growth indicates significant potential, especially in Europe and Asia where autoimmune conditions are increasing and biologic use is expanding.

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References

[1] Global Burden of Disease Study. (2019). Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries, 1990–2019. The Lancet, 396(10258), 1204-1219.

[2] AbbVie. (2023). SkyRIZI (risankizumab) Prescribing Information. Retrieved from https://www.abbvie.com

[3] IQVIA. (2022). The global market for autoimmune biologics.

[4] EvaluatePharma. (2023). Top-selling drugs forecast, 2023–2028.