What Is Ixekizumab?
Ixekizumab is an FDA-approved medication for psoriasis. It is an anti-IL17A monoclonal antibody. This means it is a type of protein designed to specifically target and block interleukin-17A, a natural protein in the body. By blocking IL-17A, ixekizumab helps reduce inflammation and symptoms associated with certain immune-related conditions.
In clinical trials, ixekizumab has been studied for its use in various forms of psoriasis, including plaque psoriasis and psoriasis vulgaris. It is also being investigated for other inflammatory conditions such as psoriatic arthritis, spondyloarthritis, and axial spondyloarthritis. Some studies have explored its effects in healthy participants and individuals with obesity. The first trial for ixekizumab began on April 21, 2010, and the latest trial is expected to conclude on March 2, 2026. A total of 58 trials have investigated ixekizumab, enrolling 15,820 participants.
Uses and Conditions Under Study
Ixekizumab is primarily studied for inflammatory skin and joint conditions, with a focus on its ability to modulate the immune response.
- Psoriasis: This chronic autoimmune disease causes skin cells to build up rapidly on the surface of the skin, forming thick, silvery scales and itchy, dry, red patches. Ixekizumab, as an anti-IL17A antibody, targets a key inflammatory pathway involved in psoriasis. Various forms, including psoriasis (13 trials), plaque psoriasis (11 trials), psoriasis vulgaris (2 trials), and guttate psoriasis (1 trial), have been investigated in a combined total of 27 trials.
- Psoriatic Arthritis and Spondyloarthritis: Psoriatic arthritis is a type of arthritis that affects some people with psoriasis, causing joint pain, stiffness, and swelling. Spondyloarthritis and axial spondyloarthritis are inflammatory conditions primarily affecting the spine and other joints. Given ixekizumab's mechanism of action, it is being studied to reduce inflammation and symptoms in these related joint conditions. These conditions are being explored in a combined total of 13 trials (8 for psoriatic arthritis, 3 for spondyloarthritis, and 2 for axial spondyloarthritis).
- Other Conditions: Ixekizumab has also been studied in healthy participants (5 trials) to understand its effects and safety profile in individuals without the target conditions. Additionally, it has been investigated in obesity (2 trials), possibly exploring the link between inflammation and metabolic health.
Dosing
Ixekizumab is administered as an injection, typically subcutaneously (under the skin). It has been studied in various formulations, including prefilled syringes and auto-injectors.
Commonly studied dosing regimens for ixekizumab involve an initial higher dose followed by maintenance doses. For example, some trials have used an initial dose of 160 mg (given as two 80 mg injections) at Week 0, followed by 80 mg every two weeks (Q2W) up to Week 12. Other regimens include 80 mg every four weeks (Q4W).
A wide range of strengths have been investigated in clinical trials to determine optimal treatment. These include single doses of 80 mg, and various regimens using 80 mg, 10 mg, 25 mg, 75 mg, 120 mg, and 150 mg. Dosing frequencies have also varied, with studies exploring administration every 2 weeks (Q2W), every 4 weeks (Q4W), and even every 12 weeks (Q12W) in some investigational settings.
Side Effects
In clinical trials, the most common side effect reported by patients taking Ixekizumab was nasopharyngitis (common cold), affecting 10.5% of patients. This was comparable to 11.2% of patients receiving placebo.
Other common side effects included:
- Upper respiratory tract infection: 5.9% of patients on Ixekizumab experienced this, compared to 8.0% on placebo.
- Injection site reaction: Occurred in 4.7% of patients taking Ixekizumab, versus 3.7% on placebo.
- Headache: Reported by 3.3% of patients on Ixekizumab, compared to 3.5% on placebo.
- Arthralgia (joint pain): Affected 3.2% of patients on Ixekizumab, versus 2.7% on placebo.
- Bronchitis: Experienced by 3.0% of patients on Ixekizumab, compared to 1.6% on placebo.
- Sinusitis: Occurred in 2.8% of patients on Ixekizumab, versus 2.5% on placebo.
- Back pain: Reported by 2.5% of patients on Ixekizumab, compared to 2.2% on placebo.
Clinical Trial Results
Clinical trials evaluated the effectiveness of Ixekizumab in treating moderate to severe psoriasis, assessing improvements in skin clearance, quality of life, and other related symptoms.
Study NCT01107457: Moderate to Severe Psoriasis
This study investigated various doses of Ixekizumab. At Week 12, a significant percentage of patients achieved at least 75% improvement in their Psoriasis Area and Severity Index (PASI 75) score:
- 82.8% of patients on 75 mg Ixekizumab achieved PASI 75, compared to 7.7% on placebo.
- 82.1% of patients on 150 mg Ixekizumab achieved PASI 75.
- Patients on 150 mg Ixekizumab experienced a mean reduction of -8.17 units in their Dermatology Life Quality Index (DLQI) score at Week 16, indicating improved quality of life, versus a -1.24 unit reduction on placebo.
- Nail psoriasis also showed improvement; patients on 150 mg Ixekizumab had a mean reduction of -19.91 units in their Nail Psoriasis Severity Index (NAPSI) score at Week 12, while placebo patients saw a 2.21 unit increase (worsening).
- Pain, measured by a Visual Analog Scale (VAS), decreased by a mean of -34.24 mm for patients on 150 mg Ixekizumab at Week 12, compared to a 3.87 mm increase on placebo.
- Anti-Ixekizumab antibodies were detected in 22.2% of patients on 150 mg and 17.2% of patients on 75 mg.
- 89.1% of patients on Ixekizumab Q2W achieved PASI 75, compared to 3.9% on placebo. For Ixekizumab Q4W, 82.6% achieved PASI 75.
- A Static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (minimal) was achieved by 81.8% of patients on Ixekizumab Q2W, versus 3.2% on placebo.
- 85.9% of patients on Ixekizumab Q2W experienced a significant reduction (at least 4 points) in itch severity, compared to 15.5% on placebo.
- Anti-Ixekizumab antibodies were found in 10.3% of patients on Q2W and 12.5% on Q4W.
- 89.7% of patients on Ixekizumab Q2W achieved PASI 75, significantly higher than 41.6% on etanercept and 2.4% on placebo.
- 83.2% of patients on Ixekizumab Q2W achieved an sPGA score of 0 or 1, compared to 36.0% on etanercept and 2.4% on placebo.
- A reduction of at least 4 points in itch severity was achieved by 85.1% of patients on Ixekizumab Q2W, versus 57.8% on etanercept and 14.1% on placebo.
- 98.7% of participants achieved PASI 75 improvement.
- 89.7% of participants achieved an sPGA score of 0 or 1.
- Participants experienced a mean reduction of -4.9 units in itch severity.
- Nail psoriasis improved with a mean reduction of -23.4 units in NAPSI score.
- 89.7% of patients on 80 mg Ixekizumab Q2W achieved PASI 75, compared to 41.6% on etanercept and 2.4% on placebo.
- 83.2% of patients on 80 mg Ixekizumab Q2W achieved an sPGA score of 0 or 1, versus 36.0% on etanercept and 2.4% on placebo.
- Approximately 88% of patients on 80 mg Ixekizumab Q2W experienced a significant reduction in itch severity (at least 4 points), compared to approximately 66.7% on etanercept and 11% on placebo.
- Anti-Ixekizumab antibodies were observed in approximately 7.7% of patients on Q2W and approximately 17.3% on Q4W.
- Obesity and Overweight
- Major Depressive Disorder
- Juvenile Psoriatic Arthritis
- Lichen Planus and Lichen Planopilaris
- Uveitis (Anterior, Intermediate, Posterior)
- Rheumatoid Arthritis and other Rheumatic Diseases
- Atopic Dermatitis and Bullous Pemphigoid
- Conditions like Covid19, Depression, and Generalized Pustular Psoriasis
Study NCT01474512: Moderate to Severe Plaque Psoriasis
This study compared Ixekizumab administered every two weeks (Q2W) or every four weeks (Q4W) to placebo. At Week 12:
Study NCT01597245 (UNCOVER-2): Moderate to Severe Chronic Plaque Psoriasis
This trial included an active comparator, etanercept. At Week 12:
Study NCT01624233: Japanese Participants with Moderate-to-Severe Psoriasis
In this study of Japanese patients, 80 mg Ixekizumab demonstrated high efficacy:
Study NCT01646177 (UNCOVER-3): Moderate to Severe Chronic Plaque Psoriasis
Similar to UNCOVER-2, this trial also included etanercept as a comparator. At Week 12:
Currently Recruiting Trials
Researchers are actively seeking participants for several clinical trials involving Ixekizumab, exploring its potential benefits across various conditions. These studies aim to deepen our understanding of how Ixekizumab works, optimize its use, and investigate its effects in new contexts, often in combination with other therapies.
One ongoing study, NCT07443956, is investigating the "Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis." This trial, sponsored by NHS Greater Glasgow and Clyde, aims to understand how weight loss (achieved with tirzepatide) or Ixekizumab treatment, or a combination of both, affects skin, joint, and fat tissues in patients with Psoriatic Arthritis, Psoriasis, and obesity or overweight BMI of 27 or higher. It plans to enroll 45 participants.
Another study from NHS Greater Glasgow and Clyde, NCT06786936, is "Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms." This trial seeks to understand the mechanisms underlying depression in immune-mediated inflammatory diseases, such as Psoriatic Arthritis and Psoriatic Plaque, using advanced brain imaging. It targets an enrollment of 50 participants.
The University Hospital, Ghent, is sponsoring a Phase 4 study, NCT06398106, on "Proactive TDM Versus Standard Use of Biologics in Psoriasis." This trial compares proactive therapeutic drug monitoring (TDM) to standard fixed dosing of biologics, including those that block interleukin 17 and 23, for Psoriasis Vulgaris. The goal is to optimize treatment and prevent under- or overdosing for 210 participants.
A study titled "Immunoclassification of Psoriasis: a Strategy for Precision Medicine," NCT05503875, is being conducted by the Second Affiliated Hospital, School of Medicine, Zhejiang University. This research aims to combine clinical manifestations and 'omics' data to explore skin cell changes in different stages of psoriasis lesions, establish new classification standards, and guide precise treatment for 100 participants.
Finally, Singapore General Hospital is conducting a Phase 4 trial, NCT04537689, on "Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis." This study is investigating the outcomes of Ixekizumab treatment and withdrawal in patients with Plaque Psoriasis, a systemic immune disease that can significantly impact quality of life. This trial plans to enroll 40 participants.
Where to Participate
While several clinical trials for Ixekizumab are actively recruiting, specific site locations are not detailed in the available data. This means that while studies are underway, information on particular cities or states where these trials are being conducted is not provided.
Generally, participants in clinical trials for Ixekizumab are typically between the ages of 18 and 90 years. These studies welcome individuals of all genders. Some trials may also include healthy volunteers, depending on the specific research questions being asked. Children are not eligible to participate in these particular studies.
Development Timeline
The journey of Ixekizumab in clinical development began on 2010-04-21, marking the start of its extensive research pipeline. Since then, a total of 58 clinical trials have been initiated, enrolling a substantial 15,820 participants to date, with the latest trial projected to conclude by 2026-03-02.
Eli Lilly and Company has been the primary driving force behind Ixekizumab's development, sponsoring 35 of these trials. The drug's development has progressed through various phases, with a significant focus on later-stage research, including 27 Phase 3 trials and 10 Phase 4 trials, alongside earlier-stage investigations.
Initially, Ixekizumab's exploration began with conditions such as IBS-C and hyperphosphatemia. Over time, the development pipeline expanded considerably, reflecting a growing understanding of its therapeutic potential. The focus broadened to include a wide range of immune-mediated inflammatory diseases. Key areas of expansion included Psoriatic Arthritis, Spondyloarthritis, and various forms of Psoriasis, such as Psoriasis Vulgaris, Guttate Psoriasis, and Plaque Psoriasis. The drug's investigation also extended to more diverse conditions, including:
This broad exploration highlights Ixekizumab's journey from initial indications to a comprehensive investigation across numerous inflammatory and immune-related conditions.