New drug aims to tame giant cell arteritis with fewer steroids

NCT ID NCT04930094

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested secukinumab, a biologic drug, in 354 people with giant cell arteritis (GCA), a condition causing inflamed arteries. Participants received either secukinumab or a placebo, along with a steroid taper. The goal was to see if secukinumab could help more people achieve sustained remission while reducing their total steroid use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Secukinumab
What this could lead to: If successful, this could offer a new treatment option for giant cell arteritis that helps patients achieve remission with less reliance on steroids.
What could go wrong: This is a phase 3 trial, but results are not yet published. The drug may not prove superior to placebo, and side effects like infections are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

354 people

The number who actually took part.

Started

Oct 2021

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study. 2. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study. 3. Male or non-pregnant, non-lactating female patients at least 50 years of age. 4. Diagnosis of GCA based on meeting all of the following criteria: * Age at onset of disease ≥ 50 years. * Unequivocal cranial symptoms of GCA (e.g., new-onset localized headache, scalp or temporal artery tenderness, permanent or temporary ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication), and/or unequivocal symptoms of polymyalgia rheumatica (PMR) (defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness) and/or symptoms of limb ischemia (claudication). * TAB revealing features of GCA and/or cross-sectional imaging study such as ultrasound (e.g., cranial or axillary), MRI/MRA, CTA, or PET-CT with evidence of vasculitis. 5. Active disease as defined by meeting both of the following within 6 weeks of BSL (see Section 8.1 for details) * Presence of signs or symptoms attributed to active GCA and not related to prior damage (e.g., visual loss that occurred prior to 6 weeks before BSL without new findings occurring within 6 weeks of BSL) * Elevated ESR ≥ 30 mm/hr or CRP ≥ 10 mg/L attributed to active GCA or active GCA on TAB or on imaging study. 6. Patients to meet definition of new-onset GCA or relapsing GCA: * Definition of new-onset GCA\*: GCA that is diagnosed within 6 weeks of BSL visit * Definition relapsing GCA: GCA diagnosed \> 6 weeks before BSL visit and following institution of an appropriate treatment course for GCA, participant has experienced recurrence of active symptoms or signs of disease after resolution. * The 6-week timeframe is to be calculated from the date of suspected GCA diagnosis. Suspected diagnosis is defined as date when GC therapy was initiated. 7. Patients' current GCA episode should be treatable with a dose of prednisone (or equivalent) designed to adequately achieve disease control in accordance with international guidelines. If this is not possible due to concerns regarding GC toxicity, the patient should not be enrolled. It must be medically appropriate for the patient to receive prednisone (or equivalent) 20 mg-60 mg daily (or equivalent) at BSL. 8. Patients taking MTX (≤ 25 mg/week) are allowed to continue their medication provided they have taken it for at least 2 months and are on a stable dose for at least 4 weeks prior to randomization and if they are on stable folic acid treatment before randomization. Exclusion Criteria: 1. Pregnant or nursing (lactating) women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test. 2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during study treatment or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks after treatment discontinuation). Also, contraception should be used in accordance with locally approved prescribing information of concomitant medications administered (e.g., Rescue Treatment). Effective contraception methods include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. * Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment are they not considered to be of child-bearing potential. * Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks before taking study treatment. * Male sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to screening. * Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). NOTE: for United Kingdom: with spermicidal foam/gel/film/cream/vaginal suppository. * Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example, hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS). In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. * Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms). Women participants are considered not of child-bearing potential if they are post-menopausal or have had, surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks prior to first dose of study treatment in the study . In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered to be not of child-bearing potential. If local regulations are more stringent than the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the Informed Consent Form (ICF). 3. Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor. 4. Patients treated with any cell-depleting therapies. 5. Previous participation in a clinical trial where the outcome of treatment with the GCA drug is unknown. This does not include trials where the treatment for GCA was GCs, MTX, leflunomide or azathioprine 6. Patients who have been treated with inhibitors directly targeting IL-1, or IL-1 receptor, IL-12 and IL-23, or abatacept within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL. 7. Treatment with tocilizumab, other IL-6/IL6-R inhibitor or JAK inhibitor within 12 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL, or if the patient did not respond to or experienced a relapse during treatment any time before BSL. 8. Any treatment received for GCA in which patient did not respond to treatment or experienced a relapse while on that treatment any time before BSL. This also includes patients who were treated in a clinical trial for GCA. Patients who failed on treatment with GCs, MTX, leflunomide and/or azathioprine may be included. 9. Patients treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to BSL. 10. Patients treated (i.e. systemic therapy) with cyclophosphamide or hydroxychloroquine within 6 months prior to BSL, or tacrolimus, everolimus, cyclosporine A, azathioprine, sulfasalazine, mycophenolate mofetil within 4 weeks prior to BSL. 11. Patients treated with leflunomide within 8 weeks of BSL unless a cholestyramine washout has been performed in which case the patient must be treated within 4 weeks of BSL. 12. Patients treated with an alkylating agent within 5 years prior to BSL, unless specified in other exclusion criteria. 13. Patients requiring or anticipated to require systemic chronic glucocorticoid therapy or pulses of glucocorticoids for reasons other than GCA (e.g., COPD, asthma, planned surgery) at screening or randomization. 14. Criterion removed in protocol V01. 15. Patients requiring chronic (i.e., not occasional "prn") high potency opioid analgesics for pain management. 16. Use of other investigational drugs within 5 half-lives of enrollment or within 30 days (e.g. small molecules) or until the expected pharmacodynamic effect has returned to BSL (e.g., biologics), whichever is longer; or longer if required by local regulations. 17. History of hypersensitivity or contraindication to any of the study treatments or its excipients or to drugs of similar chemical classes. 18. Active IBD or other ongoing inflammatory diseases other than GCA that might confound the evaluation of the benefit of secukinumab therapy, including uveitis at screening or randomization. 19. Major ischemic event (e.g., myocardial infarction, stroke, etc.) or transient ischemic attack (TIA) (except ischemia-related vision loss), related or unrelated to GCA, within 12 weeks of screening. 20. Confirmed diagnosis of any primary form of systemic vasculitis, other than GCA. 21. Any other systemic biologics (e.g., denosumab, TNFα inhibitors) within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL, or anticipated use of a systemic biologic prior to EOS 22. Active ongoing diseases which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for treatment with immunomodulatory therapy. 23. Significant medical problems or diseases, including but not limited to the following: uncontrolled hypertension (≥ 160/95 mmHg), congestive heart failure (New York Heart Association (NYHA) status of class III or IV) and uncontrolled diabetes mellitus. 24. History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests (LFTs) such as Aspartate Aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) or serum bilirubin. The investigator should be guided by the following criteria: * SGOT (AST) and SGPT (ALT) may not exceed 3 × the upper limit of normal (ULN). A single parameter elevated up to and including 3 × ULN should be re-checked once more as soon as possible, and in all cases, at least prior to randomization, to rule-out laboratory error. * Alkaline phosphatase may not exceed 2 × ULN. An elevation up to and including 2 × ULN should be re-checked once more as soon as possible, and in all cases, at least prior to randomization, to rule-out laboratory error. * Total bilirubin may not exceed 2 × ULN. If the total bilirubin concentration is increased above 2 × ULN, total bilirubin should be differentiated into the direct and indirect reacting bilirubin. 25. Criterion removed in protocol V01 26. Screening total WBC count \< 3,000/μL, or platelets \< 100,000/μL or neutrophils \< 1,500/μL or Hgb \< 8.3 g/dL (83 g/L). 27. Active infections during the last 2 weeks prior to randomization. 28. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold Plus test. Patients with a positive test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active TB. If the test result is indeterminate, the investigator may repeat the test once or may proceed directly to perform the work-up for TB as per local procedures. If presence of latent TB is established then treatment according to local country guidelines must be initiated prior to randomization. 29. Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C (if not treated and cured) at screening or randomization 30. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed). 31. Live vaccinations (e.g., monkey pox vaccine, oral polio vaccine, varicella/zoster vaccines) within 6 weeks prior to BSL, or planned or anticipated potential need for live vaccination during study participation until 12 weeks after last study treatment administration. 32. Current severe progressive or uncontrolled disease, which in the judgment of the clinical investigator renders the patient unsuitable for the trial. 33. Any medical or psychiatric condition, which, in the investigator's opinion, would preclude the patient from adhering to the protocol or completing the study per protocol. 34. Donation or loss of 400 mL or more of blood within 8 weeks before randomization. 35. History or evidence of ongoing alcohol or drug abuse, within the last 6 months before randomization.

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Conditions

The condition(s) this trial relates to.

Giant Cell Arteritis temporal arteritis vasculitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Giant cell arteritis (GCA)

Contacts and locations

Locations

Advanced Rheumatology of Houston

Spring, Texas, 77382, United States
Cedars Sinai Medical Center

Los Angeles, California, 90048, United States
IRIS Research and Development

Plantation, Florida, 33324, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Novartis Investigative Site

Iowa City, Iowa, 52242, United States
Novartis Investigative Site

La Plata, Buenos Aires, B1900AWT, Argentina
Novartis Investigative Site

Capital Federal, C1023AAB, Argentina
Novartis Investigative Site

Parramatta, New South Wales, 2150, Australia
Novartis Investigative Site

Southport, Queensland, 4215, Australia
Novartis Investigative Site

Hobart, Tasmania, 7000, Australia
Novartis Investigative Site

Heidelberg Heights, Victoria, 3081, Australia
Novartis Investigative Site

Malvern East, Victoria, 3145, Australia
Novartis Investigative Site

Murdoch, Western Australia, 6150, Australia
Novartis Investigative Site

Liverpool, 2170, Australia
Novartis Investigative Site

Innsbruck, Tyrol, 6020, Austria
Novartis Investigative Site

Graz, 8036, Austria
Novartis Investigative Site

Leuven, 3000, Belgium
Novartis Investigative Site

Liège, 4000, Belgium
Novartis Investigative Site

Juiz de Fora, Minas Gerais, 36010 570, Brazil
Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Novartis Investigative Site

Sao Jose Rio Preto, São Paulo, 15090 000, Brazil
Novartis Investigative Site

Plovdiv, 4000, Bulgaria
Novartis Investigative Site

Plovdiv, 4002, Bulgaria
Novartis Investigative Site

Montreal, Quebec, H1T 2M4, Canada
Novartis Investigative Site

Sherbrooke, Quebec, J1G 2E8, Canada
Novartis Investigative Site

Trois-Rivières, Quebec, G9A 3X2, Canada
Novartis Investigative Site

Brno, 625 00, Czechia
Novartis Investigative Site

Prague, 128 00, Czechia
Novartis Investigative Site

Prague, 148 00, Czechia
Novartis Investigative Site

Uherské Hradiště, 686 01, Czechia
Novartis Investigative Site

Aarhus N, 8200, Denmark
Novartis Investigative Site

Esbjerg, 6700, Denmark
Novartis Investigative Site

Vejle, DK-7100, Denmark
Novartis Investigative Site

Tallinn, 10138, Estonia
Novartis Investigative Site

Tartu, 50708, Estonia
Novartis Investigative Site

Helsinki, 00290, Finland
Novartis Investigative Site

Kuopio, 70100, Finland
Novartis Investigative Site

Lahti, 15850, Finland
Novartis Investigative Site

Turku, 20520, Finland
Novartis Investigative Site

Brest, 29200, France
Novartis Investigative Site

Dijon, 21000, France
Novartis Investigative Site

Le Mans, 72000, France
Novartis Investigative Site

Lille, 59037, France
Novartis Investigative Site

Marseille, 13008, France
Novartis Investigative Site

Nantes, 44093, France
Novartis Investigative Site

Paris, 75013, France
Novartis Investigative Site

Paris, 75014, France
Novartis Investigative Site

Strasbourg, 67000, France
Novartis Investigative Site

Toulouse, 31059, France
Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Novartis Investigative Site

Würzburg, Bavaria, 97080, Germany
Novartis Investigative Site

Dresden, Saxony, 01307, Germany
Novartis Investigative Site

Berlin, 13125, Germany
Novartis Investigative Site

Bonn, 53105, Germany
Novartis Investigative Site

Dresden, 01067, Germany
Novartis Investigative Site

Erlangen, 91054, Germany
Novartis Investigative Site

Herne, 44649, Germany
Novartis Investigative Site

Ludwigshafen, 67063, Germany
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Athens, 115 27, Greece
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Guatemala City, 01010, Guatemala
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Pécs, Baranya, 7623, Hungary
Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, 4032, Hungary
Novartis Investigative Site

Budapest, H-1083, Hungary
Novartis Investigative Site

Szeged, 6725, Hungary
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Tel Aviv, 6423906, Israel
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Brescia, BS, 25123, Italy
Novartis Investigative Site

Cona, FE, 44124, Italy
Novartis Investigative Site

Florence, FI, 50134, Italy
Novartis Investigative Site

Milan, MI, 20132, Italy
Novartis Investigative Site

Siena, SI, 53100, Italy
Novartis Investigative Site

Gjettum, 1346, Norway
Novartis Investigative Site

Moss, 1538, Norway
Novartis Investigative Site

Bydgoszcz, 85-168, Poland
Novartis Investigative Site

Krakow, 30-002, Poland
Novartis Investigative Site

Lisbon, 1649-035, Portugal
Novartis Investigative Site

Ponte de Lima, 4990-041, Portugal
Novartis Investigative Site

Santiago Compostela, A Coruna, 15706, Spain
Novartis Investigative Site

Badalona, Barcelona, 08916, Spain
Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain
Novartis Investigative Site

Bilbao, Bizkaia, 48013, Spain
Novartis Investigative Site

Santander, Cantabria, 39008, Spain
Novartis Investigative Site

Pamplona, Navarre, 31008, Spain
Novartis Investigative Site

Barcelona, 08036, Spain
Novartis Investigative Site

Barcelona, 08041, Spain
Novartis Investigative Site

Madrid, 28009, Spain
Novartis Investigative Site

Madrid, 28046, Spain
Novartis Investigative Site

Valencia, 46026, Spain
Novartis Investigative Site

Malmö, 221 85, Sweden
Novartis Investigative Site

Basel, 4031, Switzerland
Novartis Investigative Site

Geneva, 1211, Switzerland
Novartis Investigative Site

Sankt Gallen, 9007, Switzerland
Novartis Investigative Site

Zurich, 8091, Switzerland
Novartis Investigative Site

Istanbul, Fatih, 34098, Turkey (Türkiye)
Novartis Investigative Site

Istanbul, Pendik, 34899, Turkey (Türkiye)
Novartis Investigative Site

Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)
Novartis Investigative Site

Edinburgh, Scotland, EH4 2XU, United Kingdom
Novartis Investigative Site

Stoke-on-Trent, Staffordshire, ST6 7AG, United Kingdom
Novartis Investigative Site

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
Novartis Investigative Site

Dundee, DD1 9SY, United Kingdom
Osteoporosis and Clinical Trial Ctr

Hagerstown, Maryland, 21740, United States
Precision Comp Clin Research

Grapevine, Texas, 76051, United States
Sarasota Arthritis Res Ctr

Sarasota, Florida, 34239, United States
University Of Iowa

Iowa City, Iowa, 52242, United States
West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

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