Secukinumab Clinical Trials

What Is Secukinumab?

Secukinumab, also known by the brand name Cosentyx, is an FDA-approved medication for psoriasis, hidradenitis suppurativa, pediatric plaque psoriasis, enthesitis-related arthritis, and juvenile psoriatic arthritis. It is a fully human monoclonal antibody that specifically targets interleukin-17A (IL-17A). IL-17A is a protein in the body that plays a key role in the inflammation seen in various autoimmune conditions. By blocking IL-17A, secukinumab helps reduce inflammation and improve symptoms.

Beyond its approved uses, secukinumab is currently being investigated in clinical trials for a range of other conditions. These include psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, axial spondyloarthritis, and various forms of psoriasis such as plaque psoriasis, psoriasis vulgaris, moderate to severe plaque-type psoriasis, and nail psoriasis. Researchers are also studying secukinumab for less common inflammatory conditions like Takayasu's arteritis, thyroid eye disease, discoid lupus erythematosus, and necrobiosis lipoidica diabeticorum.

Uses and Conditions Under Study

Secukinumab is being studied in a total of 170 clinical trials, with 11 trials currently recruiting participants. These studies involve a large number of participants, with a total enrollment of 76,752 individuals across all trials. The first trial for secukinumab began in 2010, and studies are ongoing with the latest projected completion date in 2026.

Many trials focus on inflammatory skin conditions. Psoriasis, including plaque psoriasis, psoriasis vulgaris, and moderate to severe plaque-type psoriasis, is being investigated in 37 trials. Secukinumab targets IL-17A, which is a key driver of the inflammation and rapid skin cell growth characteristic of psoriasis. Nail psoriasis is also a focus of study, with secukinumab being an FDA-approved treatment for psoriasis generally.

Another significant area of research is inflammatory joint conditions. Psoriatic arthritis is being studied in 21 trials, ankylosing spondylitis in 9 trials, and axial spondyloarthritis in 5 trials. These conditions involve inflammation of the joints and spine, and secukinumab's ability to reduce IL-17A may help alleviate pain and stiffness. Rheumatoid arthritis is also being explored in 5 trials.

Hidradenitis suppurativa (HS), a chronic inflammatory skin disease characterized by painful nodules and abscesses, is the subject of 6 trials. Secukinumab is approved for moderate to severe HS, with studies showing it can lead to clinical response in a significant percentage of patients. Other conditions under investigation include Takayasu's arteritis, a rare large vessel vasculitis; thyroid eye disease, an autoimmune disorder affecting the eyes; discoid lupus erythematosus, a chronic skin manifestation of lupus; and necrobiosis lipoidica diabeticorum, a rare skin condition often associated with diabetes.

Dosing

Secukinumab is typically administered as a subcutaneous injection. It has been studied in various forms, including auto-injectors and prefilled syringes. Intravenous (I.V.) administration has also been investigated in some trials.

Commonly studied strengths for secukinumab include 300 mg, 150 mg, and 75 mg. The dosing schedule often involves an initial induction period with more frequent injections, followed by a maintenance phase with less frequent dosing. For example, in some studies, secukinumab 300 mg is administered weekly during the first 4-5 weeks (Weeks 0, 1, 2, 3, and 4), followed by maintenance dosing every 4 weeks (Q4W).

For conditions like moderate to severe hidradenitis suppurativa, secukinumab 300 mg subcutaneous injection every 2 weeks (Q2W) has been studied. Other regimens include secukinumab 300 mg every 4 weeks, with options for up-titration in non-responders. In some trials, different doses such as 150 mg or 75 mg have been explored, sometimes with or without a loading dose. Pediatric plaque psoriasis and juvenile psoriatic arthritis are among the approved indications, and specific dosing for these populations would be determined by a healthcare provider based on the approved prescribing information.

Side Effects

The most common side effect reported in clinical trials for Secukinumab was nasopharyngitis (common cold). Across 46 trials involving 24,813 patients, 18.0% of patients taking Secukinumab experienced nasopharyngitis, compared to 10.3% of patients on placebo. Other common side effects observed with Secukinumab, compared to placebo, included:

• Upper respiratory tract infection: 10.9% on Secukinumab vs 5.8% on placebo
• Headache: 8.0% on Secukinumab vs 5.8% on placebo
• Diarrhea: 6.1% on Secukinumab vs 4.0% on placebo
• Arthralgia (joint pain): 5.2% on Secukinumab vs 4.0% on placebo
• Back pain: 5.2% on Secukinumab vs 3.0% on placebo
• Hypertension (high blood pressure): 4.9% on Secukinumab vs 2.6% on placebo
• Bronchitis: 4.8% on Secukinumab vs 1.9% on placebo

Clinical Trial Results

Ankylosing Spondylitis

In a 16-week study (NCT01358175) evaluating Secukinumab in patients with active ankylosing spondylitis, Secukinumab demonstrated significant improvements in disease activity and quality of life compared to placebo. For instance, 60.8% of patients receiving Secukinumab 150 mg achieved an ASAS 20 response (a measure of improvement in disease activity), compared to 28.7% on placebo. Similarly, 41.6% of patients on Secukinumab 150 mg achieved an ASAS 40 response, versus 13.1% on placebo. Patients treated with Secukinumab also experienced greater reductions in disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), with a mean reduction of 2.32 units for Secukinumab 150 mg compared to 0.59 units for placebo. Improvements were also seen in physical function and quality of life.

Plaque-Type Psoriasis

Two studies investigated Secukinumab for moderate to severe chronic plaque-type psoriasis. In one trial (NCT01358578) comparing Secukinumab to Etanercept and placebo, Secukinumab showed superior efficacy. At Week 12, 58.3% of patients on Secukinumab 300 mg achieved a PASI 90 response (90% reduction in Psoriasis Area and Severity Index), compared to 22.3% on Etanercept and 1.7% on placebo. For an IGA (Investigator's Global Assessment) score of 0 or 1 (clear or almost clear skin), 67.3% of patients on Secukinumab 300 mg achieved this goal, versus 29.3% on Etanercept and 3.0% on placebo.

Another study (NCT01365455) further confirmed the efficacy of subcutaneous Secukinumab. At Week 12, 81.6% of patients on Secukinumab 300 mg achieved a PASI 75 response, compared to 4.5% on placebo. A PASI 90 response was achieved by 59.2% of patients on Secukinumab 300 mg, versus 1.2% on placebo. Patients on Secukinumab 300 mg also saw a median reduction of 86.4% in their Dermatology Life Quality Index (DLQI) score, indicating a significant improvement in quality of life, compared to a 9.1% reduction for placebo. The median time to achieve a PASI 75 response was 57 days for both Secukinumab 150 mg and 300 mg doses.

Rheumatoid Arthritis

A study (NCT01359943) in patients with rheumatoid arthritis taking methotrexate showed that Secukinumab improved disease activity.

Currently Recruiting Trials

Researchers are actively seeking participants for several clinical trials involving secukinumab, known commercially as Cosentyx®. These studies aim to further understand its effects across a range of inflammatory conditions, from skin disorders to joint diseases, and to explore new ways to optimize treatment.

• A study in Korea, NCT07243782, is conducting post-marketing surveillance for individuals with Hidradenitis Suppurativa, Pediatric Plaque Psoriasis, and Juvenile Idiopathic Arthritis. This observational study by Novartis Pharmaceuticals is enrolling 76 participants.
• For pediatric participants with Juvenile Psoriatic Arthritis, a Phase 1 study, NCT06751238, is evaluating the pharmacokinetics, safety, and tolerability of intravenous secukinumab over up to 6 years. Novartis Pharmaceuticals is sponsoring this study, which aims to enroll 20 children.
• Another trial, NCT06786936, is exploring the connection between IL-17 and depressive symptoms in people with Psoriatic Arthritis and Psoriatic Plaque. This study, sponsored by NHS Greater Glasgow and Clyde, is recruiting 50 participants.
• Peking Union Medical College is conducting an observational study, NCT07109765, to assess the efficacy and safety of secukinumab for moderate to severe Hidradenitis Suppurativa, with an enrollment target of 50 participants.
• In Korea, Novartis Pharmaceuticals is sponsoring a real-world observational study, NCT06905288, to evaluate secukinumab's effectiveness and safety in 70 biologic-naïve Ankylosing Spondylitis patients.
• The University Hospital, Ghent, is leading a Phase 4 study, NCT06398106, comparing proactive therapeutic drug monitoring with standard biologic dosing for Psoriasis Vulgaris. This study seeks 210 participants.
• A randomized trial, NCT06707246, is comparing the efficacy and safety of secukinumab with tofacitinib for moderate to severe Hidradenitis Suppurativa in Chinese patients. This study, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University, plans to enroll 60 individuals.
• Tongji Hospital is conducting a Phase 4 study, NCT05303285, to evaluate the safety and efficacy of secukinumab 300mg in Chinese adults with active Ankylosing Spondylitis. This study aims for 100 participants.
• An observational study, NCT05503875, is focusing on the immunoclassification of Psoriasis to guide precision medicine. Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University, it is recruiting 100 participants.
• Novartis Pharmaceuticals is sponsoring a large Phase 4 open-label extension study, NCT04638647, to assess the long-term safety of secukinumab in participants who have completed previous Novartis trials. This study has an enrollment target of 1000 individuals.
• Peking Union Medical College is also conducting an observational study, NCT06926192, to analyze the efficacy and safety of secukinumab when combined with surgery for moderate to severe Hidradenitis Suppurativa, with 100 participants.

Where to Participate

Clinical trials for secukinumab are being conducted across a wide geographic area, offering opportunities for participation in various locations. Currently, there are 35 sites across 18 states in the United States, as well as international locations mentioned in specific trials.

Top recruiting locations include:

• Portland, Oregon (2 sites)
• La Mesa, California (1 site)
• San Leandro, California (1 site)
• Santa Monica, California (1 site)
• Upland, California (1 site)
• Van Nuys, California (1 site)
• West Hills, California (1 site)
• Denver, Colorado (1 site)
• Boca Raton, Florida (1 site)
• Gainesville, Florida (1 site)

Eligibility criteria for these trials are broad, generally accepting participants aged 2 to 100 years, of all genders. Some studies also welcome healthy volunteers, and many are specifically designed for children.

Development Timeline

The journey of secukinumab, also known as Cosentyx®, in clinical development began on November 30, 2010. Since then, a robust research program has unfolded, encompassing a total of 170 trials and enrolling over 76,752 participants.

Novartis Pharmaceuticals has been the primary driver of this extensive research, sponsoring 103 trials. Early development phases included a mix of Phase 1, Phase 2, and Early Phase 1 studies, gradually progressing to larger Phase 3 and Phase 4 trials, which account for the majority of studies with 79 and 37 trials respectively.

Initially, research explored conditions such as IBS-C and hyperphosphatemia. However, the pipeline quickly expanded to focus on immune-mediated inflammatory diseases. Key milestones included the investigation of Plaque Psoriasis, Ankylosing Spondylitis, and Hidradenitis Suppurativa. Over time, the scope broadened significantly to include a diverse array of conditions such as Psoriasis Vulgaris, Rheumatoid Arthritis, Juvenile Psoriatic Arthritis, Giant Cell Arteritis, and various forms of Ichthyosis. Recent trials continue to explore new applications, including the role of IL-17 in depression associated with Psoriatic Arthritis, and the efficacy of secukinumab in combination with surgery for Hidradenitis Suppurativa, demonstrating ongoing commitment to understanding and expanding the therapeutic potential of this drug.