CLINICAL TRIALS PROFILE FOR BRODALUMAB

All Clinical Trials for brodalumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01708590 ↗	Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects	Terminated	Amgen	Phase 3	2012-08-01	The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.
NCT01708590 ↗	Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects	Terminated	Bausch Health Americas, Inc.	Phase 3	2012-08-01	The purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.
NCT01708603 ↗	P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis	Terminated	Amgen	Phase 3	2012-08-01	The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses
NCT01708603 ↗	P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis	Terminated	Bausch Health Americas, Inc.	Phase 3	2012-08-01	The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses
NCT01708629 ↗	Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects	Terminated	Amgen	Phase 3	2012-09-01	The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.
NCT01708629 ↗	Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects	Terminated	Bausch Health Americas, Inc.	Phase 3	2012-09-01	The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis. A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis. A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

Clinical Trial Conditions for brodalumab

Condition Name

Condition Name for brodalumab
Intervention	Trials
Psoriasis	9
Moderate to Severe Plaque Psoriasis	5
Hidradenitis Suppurativa	4
Psoriatic Arthritis	4

Condition MeSH

Condition MeSH for brodalumab
Intervention	Trials
Psoriasis	15
Arthritis, Psoriatic	4
Hidradenitis Suppurativa	4
Hidradenitis	4

Clinical Trial Locations for brodalumab

Trials by Country

Trials by Country for brodalumab
Location	Trials
United States	136
Canada	33
Spain	14
Australia	11
Mexico	10

Trials by US State

Trials by US State for brodalumab
Location	Trials
New York	11
Texas	8
Florida	7
California	7
Arizona	6

Clinical Trial Progress for brodalumab

Clinical Trial Phase

Clinical Trial Phase for brodalumab
Clinical Trial Phase	Trials
PHASE4	1
PHASE1	1
Phase 4	6

Clinical Trial Status

Clinical Trial Status for brodalumab
Clinical Trial Phase	Trials
Completed	10
Recruiting	5
Terminated	4

Clinical Trial Sponsors for brodalumab

Sponsor Name

Sponsor Name for brodalumab
Sponsor	Trials
Amgen	8
Bausch Health Americas, Inc.	8
Kyowa Kirin Co., Ltd.	3

Sponsor Type

Sponsor Type for brodalumab
Sponsor	Trials
Industry	29
Other	14
UNKNOWN	1

Brodalumab: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 5, 2026

What is the current status of brodalumab clinical trials?

Brodalumab, developed by AstraZeneca and Amgen, is an interleukin-17 receptor A (IL-17RA) antagonist approved for moderate to severe plaque psoriasis in the US and some regions globally. Its primary indication is plaque psoriasis, with ongoing investigations into other autoimmune conditions.

Clinical Trials Overview:

• Approved Use: U.S. FDA approved in 2017 (under the name Siliq) for psoriasis.
• Phase III Trials: Completed or ongoing to evaluate efficacy in psoriatic arthritis and Crohn's disease.
• Recent Trials:
  • NCT03022052: Evaluates brodalumab in axial spondyloarthritis.
  • NCT04503405: Examines its role in generalized pustular psoriasis.
• Downsides in Trials: Some trials, including for Crohn's disease, were halted due to adverse events or lack of efficacy.

Regulatory Status:

• Approved in the U.S., Japan, and South Korea.
• Not approved in the European Union due to safety concerns related to suicidal ideation (noted in post-marketing surveillance).

What are the key indications and recent developments?

Approved Indications:

• Moderate to severe plaque psoriasis.
• Psoriatic arthritis (pending regional approval in select Markets).

Recent Research:

• Focuses on expanding indications to other IL-17 mediated conditions.
• Trials for generalized pustular psoriasis and axial spondyloarthritis show promise but remain under review.
• Ongoing studies aim to address safety concerns, especially neuropsychiatric adverse events.

How does brodalumab compare to other IL-17 inhibitors?

Drug	Year Approved	Indications	Market Share	Dosage Frequency	Major Side Effects
Brodalumab	2017	Psoriasis, Psoriatic arthritis	Moderate	Subcutaneous every 2 weeks	Suicidal ideation, neutropenia
Secukinumab	2015	Psoriasis, psoriatic arthritis, ankylosing spondylitis	High	Weekly or monthly	Same as brodalumab, lower psychiatric risks
Ixekizumab	2016	Psoriasis, psoriatic arthritis	High	Every 2-4 weeks	Injection site reactions

Market Position: Brodalumab targets the IL-17 pathway differently by inhibiting IL-17RA, potentially affecting a wider cytokine subset than IL-17A inhibitors (secukinumab, ixekizumab). Its market share remains limited due to safety concerns and competitive pressure.

What is the market outlook for brodalumab over the next five years?

Market Size:

• Estimated global psoriasis therapeutics market projected to reach USD 40 billion by 2028, growing at 9% CAGR (BCC Research).
• Brodalumab's segment remains a fraction of this, primarily in the North American and Japanese markets.

Market Drivers:

• Increasing prevalence of psoriasis and psoriatic arthritis.
• The potential to expand into other indications such as inflammatory bowel disease (IBD) and ankylosing spondylitis.
• The development of safer formulations and dosing schedules.

Market Challenges:

• Safety profile concerns, specifically psychiatric side effects.
• Competition from other IL-17 inhibitors with broader approval and established safety records.
• Limited approval outside the US and select Asian countries, restricting market penetration.

Future Projections:

• Moderate growth expected over the next five years.
• Possible expansion if ongoing trials demonstrate safety and efficacy in new indications.
• Potential market share gains if Amgen and AstraZeneca mitigate safety concerns through formulation or patient selection strategies.

What are the regulatory and commercial risks?

• Regulatory: Post-marketing safety issues, especially suicidal ideation, need ongoing surveillance.
• Commercial: Competition from other biologics with better safety profiles or longer track records.
• Development: Failure in upcoming trials for additional indications may limit growth.

Key Takeaways

• Brodalumab's approval status remains regional; it faces safety issues impacting global reach.
• Its mechanism of IL-17RA inhibition offers a competitive edge but has safety trade-offs.
• Market growth depends heavily on safety profile improvements and approval expansion.
• The competitive landscape is crowded, with secukinumab and ixekizumab dominating the IL-17 space.
• Ongoing trials for new indications could influence long-term market potential.

FAQs

1. Will brodalumab receive approval for other autoimmune conditions?
Pending positive trial results and regulatory review, brodalumab may receive approval for conditions like axial spondyloarthritis and pustular psoriasis, but safety concerns could delay or limit approvals.

2. How significant are safety concerns related to psychiatric adverse events?
Post-marketing data indicate an increased risk of suicidal ideation, influencing regulatory decisions, particularly outside the US. This remains a key development and marketing risk.

3. What is the competitive advantage of brodalumab over IL-17A inhibitors?
Brodalumab blocks IL-17RA, inhibiting multiple IL-17 cytokines, potentially offering broader immunomodulation. However, safety concerns restrict its widespread use.

4. What regions show the strongest adoption of brodalumab?
The US, Japan, and South Korea exhibit the highest market penetration, with limited acceptance elsewhere due to safety profiles.

5. How could biosimilars influence brodalumab's market?
Biosimilars are unlikely in the near term due to biological complexity and the relatively recent patent expiration; however, if global approvals expand, biosimilars could increase competition.

References

1. FDA approves brodalumab for psoriasis. 2017.
2. BCC Research, 2022. Global psoriasis therapeutics market forecast.
3. Amgen, Brodalumab prescribing information.
4. EMA safety review of IL-17 inhibitors.
5. ClinicalTrials.gov. Various trials on brodalumab.