Secukinumab for Giant Cell Arteritis

(GCAptAIN Trial)

Not currently recruiting at 147 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called secukinumab for giant cell arteritis (GCA), an inflammatory condition affecting blood vessels that often causes headaches, scalp pain, and vision problems. Researchers aim to determine if secukinumab, combined with a glucocorticoid medication, can manage GCA symptoms more effectively than a placebo. Participants will receive either secukinumab or a placebo, along with a controlled prednisone (a type of steroid) regimen. The study seeks individuals diagnosed with GCA who are experiencing active symptoms like new headaches or vision issues. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants the chance to contribute to the development of a promising new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that secukinumab is generally safe for patients with giant cell arteritis (GCA). In one study, patients who took secukinumab experienced better long-term symptom relief compared to those on a placebo, demonstrating its effectiveness in managing GCA. Although another study did not meet its primary goal, the safety profile of secukinumab remained consistent with previous findings. This indicates that while it may not have been effective for everyone, it was generally safe to use.

No unusual side effects were reported, suggesting that secukinumab is a safe option for many people. As with any treatment, participants should discuss potential risks with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about secukinumab for treating Giant Cell Arteritis because it targets interleukin-17A, a protein involved in inflammation, which is different from the standard corticosteroid treatment like prednisone. Secukinumab, administered via injection, could potentially reduce reliance on long-term steroid use and its associated side effects. This treatment also offers dosing flexibility with options of 150 mg or 300 mg, providing personalized approaches to managing the condition.

What evidence suggests that secukinumab might be an effective treatment for giant cell arteritis?

Research suggests that secukinumab might help treat giant cell arteritis (GCA). In this trial, participants will receive either secukinumab or a placebo. One study showed that 70% of patients taking secukinumab experienced a longer period without symptoms at 28 weeks, compared to 20% of those who took a placebo. Another study found that secukinumab helped patients achieve remission, confirmed by medical exams and imaging tests, especially for those unresponsive to treatments like tocilizumab. However, not all studies showed positive results, as some did not find significant improvements at 52 weeks. Despite these mixed results, secukinumab shows potential for some people with GCA. ^{1 2 3 6 7}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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, 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]

Citations

1. novartis.com novartis.com/us-en/news/media-releases/novartis-provides-update-phase-iii-gcaptain-study-cosentyx-giant-cell-arteritis-gca

Novartis provides update on Phase III GCAptAIN study of ... The GCAptAIN study did not meet its primary endpoint of sustained remission at Week 52 in adults with newly diagnosed or relapsing GCA1 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40366735/

Secukinumab is effective and safe for patients with giant ... Conclusions: Secukinumab demonstrated effectiveness in achieving clinical and imaging remission in patients with GCA failing tocilizumab. These preliminary real ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03765788

A Placebo-controlled Phase 2 Trial to Investigate the Safety ... This study was designed to evaluate the efficacy and safety of secukinumab compared to placebo to maintain disease remission up to 28 weeks.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496725011185

OP0062 Secukinumab in patients with giant cell arteritis ... Secukinumab treatment resulted in a higher sustained remission rate in GCA patients compared to placebo at week 28 (70% vs. 20%) with effects lasting 52 weeks ...

5. firstwordpharma.com firstwordpharma.com/story/5977909

Novartis' Cosentyx misses efficacy mark in Phase III giant ... Top-line results showed that Cosentyx failed to demonstrate a statistically significant improvement in sustained remission at week 52 compared ...

6. thelancet.com thelancet.com/journals/lanrhe/article/PIIS2665-9913(23)00101-7/abstract

Safety and efficacy of secukinumab in patients with giant ... Patients with active giant cell arteritis had a higher sustained remission rate in the secukinumab group than in the placebo group at week 28, in combination ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8369438/

Efficacy and safety of secukinumab in patients with giant ... There is anecdotal evidence of successful induction and maintenance of remission with the monoclonal anti-IL-17A antibody secukinumab.