Secukinumab for Giant Cell Arteritis

(GCAptAIN Trial)

Recruiting at 124 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must be taking: Glucocorticoids, Methotrexate

Must not be taking: Biologics, JAK inhibitors

Disqualifiers: Pregnancy, Uncontrolled hypertension, Active infections, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

354 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a phase III study of efficacy and safety of secukinumab versus placebo, in combination with glucocorticoid taper regimen, in patients with giant cell arteritis (GCA)

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you can continue taking methotrexate (MTX) if you've been on a stable dose for at least 4 weeks. Some medications, like certain biologics and immunosuppressants, must be stopped before joining the trial.

How is the drug secukinumab unique for treating giant cell arteritis?

Secukinumab is unique because it is an interleukin-17A (IL-17A) inhibitor, which is a different mechanism of action compared to other treatments for giant cell arteritis. It is administered as an injection under the skin and has been used successfully for conditions like psoriasis and psoriatic arthritis, making it a novel option for this condition. ^{1 2 3 4 5}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for patients at least 50 years old with Giant Cell Arteritis (GCA), who can be treated with prednisone. They must understand the study and follow its requirements, not be pregnant or breastfeeding, use effective contraception if applicable, and may continue using methotrexate under certain conditions. Exclusions include previous biologic drug exposure, significant health issues like uncontrolled diabetes or heart failure, recent blood donation, substance abuse history within six months, and certain infections.

Inclusion Criteria

I can understand and follow the study's requirements.

I am a man or a woman not pregnant or breastfeeding, and I am 50 years old or older.

I was diagnosed with GCA recently and meet all the specific criteria.

Exclusion Criteria

I have a history of chronic or recurrent infections, including tuberculosis.

You cannot have an MRI/MRA imaging sub-study due to specific health reasons.

I have not taken specific medications recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive secukinumab 300 mg or 150 mg subcutaneously at baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4, in combination with a glucocorticoid taper regimen

52 weeks

Weekly visits initially, then every four weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Secukinumab

Trial Overview The trial tests the effectiveness and safety of Secukinumab (at doses of either 300 mg or 150 mg) versus a placebo in managing GCA symptoms while tapering off glucocorticoids like prednisone. It's a phase III study where participants are randomly assigned to receive either the medication or a placebo alongside their standard treatment regimen.

Participant Groups

Group I: Secukinumab 300 mg Experimental Treatment 1 Intervention

Secukinumab 300 mg s.c. at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4. Secukinumab will be given in combination with a specified 26-week prednisone taper regimen. After the 26-week prednisone taper, participants will continue to receive placebo to prednisone until Week 52.

Group II: Secukinumab 150 mg Experimental Treatment 1 Intervention

Secukinumab 150 mg s.c. at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4. Secukinumab will be given in combination with a specified 26-week prednisone taper regimen. After the 26-week prednisone taper, participants will continue to receive placebo to prednisone until Week 52.

Group III: Placebo Placebo Group 1 Intervention

Placebo to secukinumab s.c. at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4. Placebo will be given in combination with a specified 52-week prednisone taper regimen.

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

Secukinumab demonstrated significant efficacy in treating psoriatic arthritis (PsA), showing robust improvements across all core domains, including joint counts, enthesitis, and skin severity, in a pooled analysis of 2049 patients from multiple phase III studies.

At a dosage of 300 mg, secukinumab led to complete resolution of swollen joints in 34.3% of patients and significant improvements in other symptoms, indicating its potential as an effective treatment option for various manifestations of PsA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients. Orbai, AM., McInnes, IB., Coates, LC., et al.[2021]

Secukinumab is an effective treatment for psoriatic arthritis (PsA), showing improvements in skin symptoms, enthesitis, dactylitis, and preventing the progression of joint damage, based on clinical studies.

The treatment is generally well tolerated, with common side effects including nasopharyngitis, headache, and upper respiratory infections, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab for the treatment of psoriatic arthritis. Baronaite Hansen, R., Kavanaugh, A.[2019]

In a 52-week study involving 237 patients with rheumatoid arthritis, those treated with 150 mg of secukinumab showed sustained improvements in disease activity scores from Week 20 to Week 52, indicating its long-term efficacy.

The safety profile of secukinumab remained consistent over the study period, with a 64.8% rate of adverse events, mostly mild to moderate, and no deaths reported, suggesting it is a relatively safe option for patients who do not respond to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year efficacy and safety results of secukinumab in patients with rheumatoid arthritis: phase II, dose-finding, double-blind, randomized, placebo-controlled study. Genovese, MC., Durez, P., Richards, HB., et al.[2019]

Secukinumab, a monoclonal antibody targeting IL-17A, has shown significant efficacy in improving symptoms of psoriatic arthritis in Phase III clinical trials, even in patients who had previously not responded to other treatments like NSAIDs or DMARDs.

The treatment is generally well tolerated, with mild to moderate infections being the most common side effects, making it a viable alternative to existing therapies such as tumor necrosis factor inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secukinumab: A Review in Psoriatic Arthritis. Shirley, M., Scott, LJ.[2019]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Effect of Secukinumab on the Different GRAPPA-OMERACT Core Domains in Psoriatic Arthritis: A Pooled Analysis of 2049 Patients. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Secukinumab for the treatment of psoriatic arthritis. [2019]

3. Italy pubmed.ncbi.nlm.nih.gov

Cutaneous Vasculitis During Secukinumab Treatment. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

One-year efficacy and safety results of secukinumab in patients with rheumatoid arthritis: phase II, dose-finding, double-blind, randomized, placebo-controlled study. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Secukinumab: A Review in Psoriatic Arthritis. [2019]