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Giant Cell Arteritis (GCA)Phase 3GCAptAINNCT04930094

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)

A Phase 3 study testing Secukinumab 300 mg and Secukinumab 150 mg in people with Giant Cell Arteritis (GCA), run by Novartis Pharmaceuticals at 104 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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) Read more about this study

Who is it for?
Ages 50 to 100 years
Conditions the study is for
Giant Cell Arteritis (GCA)
What is being tested?
Secukinumab 300 mg and Secukinumab 150 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
354 participants
Where
104 sitesin 27 countries
Study dates
6 Oct 2021to 18 Feb 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent must be obtained prior to participation in the study.
  • Patient must be able to understand and communicate with the investigator and comply with the requirements of the study.
  • Male or non-pregnant, non-lactating female patients at least 50 years of age.
  • 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).
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  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Who cannot join

  • 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.
  • 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.
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  • 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).
  • Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor.
  • Patients treated with any cell-depleting therapies.
  • 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
  • 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.
  • 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.
  • 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.
  • Patients treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to BSL.
  • 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.
  • 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.
  • Patients treated with an alkylating agent within 5 years prior to BSL, unless specified in other exclusion criteria.
  • 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.
  • Criterion removed in protocol V01.
  • Patients requiring chronic (i.e., not occasional "prn") high potency opioid analgesics for pain management.
  • 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.
  • History of hypersensitivity or contraindication to any of the study treatments or its excipients or to drugs of similar chemical classes.
  • 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.
  • 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.
  • Confirmed diagnosis of any primary form of systemic vasculitis, other than GCA.
  • 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
  • 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.
  • 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.
  • 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.
  • Criterion removed in protocol V01
  • 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).
  • Active infections during the last 2 weeks prior to randomization.
  • 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.
  • Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C (if not treated and cured) at screening or randomization
  • 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).
  • 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.
  • Current severe progressive or uncontrolled disease, which in the judgment of the clinical investigator renders the patient unsuitable for the trial.
  • 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.
  • Donation or loss of 400 mL or more of blood within 8 weeks before randomization.
  • History or evidence of ongoing alcohol or drug abuse, within the last 6 months before randomization.

Trial locations and contacts

104 sites in 27 countries.

104 sites in 27 countries

Spain11 sites

  • Novartis Investigative Site

    Badalona, Barcelona, 08916

  • Novartis Investigative Site

    Barcelona, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Bilbao, Bizkaia, 48013

  • Novartis Investigative Site

    Madrid, 28009

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    Santander, Cantabria, 39008

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706

  • Novartis Investigative Site

    Valencia, 46026

Other trials in Spain

United States10 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Precision Comp Clin Research

    Grapevine, Texas, 76051

  • Osteoporosis and Clinical Trial Ctr

    Hagerstown, Maryland, 21740

  • Novartis Investigative Site

    Iowa City, Iowa, 52242

  • University Of Iowa

    Iowa City, Iowa, 52242

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • IRIS Research and Development

    Plantation, Florida, 33324

  • Sarasota Arthritis Res Ctr

    Sarasota, Florida, 34239

  • Advanced Rheumatology of Houston

    Spring, Texas, 77382

Other trials in United States

France10 sites

  • Novartis Investigative Site

    Brest, 29200

  • Novartis Investigative Site

    Dijon, 21000

  • Novartis Investigative Site

    Le Mans, 72000

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Marseille, 13008

  • Novartis Investigative Site

    Nantes, 44093

  • Novartis Investigative Site

    Paris, 75013

  • Novartis Investigative Site

    Paris, 75014

  • Novartis Investigative Site

    Strasbourg, 67000

  • Novartis Investigative Site

    Toulouse, 31059

Other trials in France

Germany9 sites

  • Novartis Investigative Site

    Berlin, 13125

  • Novartis Investigative Site

    Bonn, 53105

  • Novartis Investigative Site

    Dresden, Saxony, 01307

  • Novartis Investigative Site

    Dresden, 01067

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Novartis Investigative Site

    Herne, 44649

  • Novartis Investigative Site

    Ludwigshafen, 67063

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080

Other trials in Germany

Australia7 sites

  • Novartis Investigative Site

    Heidelberg Heights, Victoria, 3081

  • Novartis Investigative Site

    Hobart, Tasmania, 7000

  • Novartis Investigative Site

    Liverpool, 2170

  • Novartis Investigative Site

    Malvern East, Victoria, 3145

  • Novartis Investigative Site

    Murdoch, Western Australia, 6150

  • Novartis Investigative Site

    Parramatta, New South Wales, 2150

  • Novartis Investigative Site

    Southport, Queensland, 4215

Other trials in Australia

Italy5 sites

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Cona, FE, 44124

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Siena, SI, 53100

Other trials in Italy

Czechia4 sites

  • Novartis Investigative Site

    Brno, 625 00

  • Novartis Investigative Site

    Prague, 128 00

  • Novartis Investigative Site

    Prague, 148 00

  • Novartis Investigative Site

    Uherské Hradiště, 686 01

Other trials in Czechia

Finland4 sites

  • Novartis Investigative Site

    Helsinki, 00290

  • Novartis Investigative Site

    Kuopio, 70100

  • Novartis Investigative Site

    Lahti, 15850

  • Novartis Investigative Site

    Turku, 20520

Other trials in Finland

Hungary4 sites

  • Novartis Investigative Site

    Budapest, H-1083

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032

  • Novartis Investigative Site

    Pécs, Baranya, 7623

  • Novartis Investigative Site

    Szeged, 6725

Other trials in Hungary

Switzerland4 sites

  • Novartis Investigative Site

    Basel, 4031

  • Novartis Investigative Site

    Geneva, 1211

  • Novartis Investigative Site

    Sankt Gallen, 9007

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

United Kingdom4 sites

  • Novartis Investigative Site

    Dundee, DD1 9SY

  • Novartis Investigative Site

    Edinburgh, Scotland, EH4 2XU

  • Novartis Investigative Site

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

  • Novartis Investigative Site

    Stoke-on-Trent, Staffordshire, ST6 7AG

Other trials in United Kingdom

Brazil3 sites

  • Novartis Investigative Site

    Juiz de Fora, Minas Gerais, 36010 570

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Novartis Investigative Site

    Sao Jose Rio Preto, São Paulo, 15090 000

Other trials in Brazil

Canada3 sites

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1G 2E8

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G9A 3X2

Other trials in Canada

Denmark3 sites

  • Novartis Investigative Site

    Aarhus N, 8200

  • Novartis Investigative Site

    Esbjerg, 6700

  • Novartis Investigative Site

    Vejle, DK-7100

Other trials in Denmark

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Ankara, Sihhiye-Altindag, 06230

  • Novartis Investigative Site

    Istanbul, Fatih, 34098

  • Novartis Investigative Site

    Istanbul, Pendik, 34899

Other trials in Turkey (Türkiye)

Argentina2 sites

  • Novartis Investigative Site

    Capital Federal, C1023AAB

  • Novartis Investigative Site

    La Plata, Buenos Aires, B1900AWT

Other trials in Argentina

Austria2 sites

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020

Other trials in Austria

Belgium2 sites

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

Other trials in Belgium

Bulgaria2 sites

  • Novartis Investigative Site

    Plovdiv, 4000

  • Novartis Investigative Site

    Plovdiv, 4002

Other trials in Bulgaria

Estonia2 sites

  • Novartis Investigative Site

    Tallinn, 10138

  • Novartis Investigative Site

    Tartu, 50708

Other trials in Estonia

Norway2 sites

  • Novartis Investigative Site

    Gjettum, 1346

  • Novartis Investigative Site

    Moss, 1538

Other trials in Norway

Poland2 sites

  • Novartis Investigative Site

    Bydgoszcz, 85-168

  • Novartis Investigative Site

    Krakow, 30-002

Other trials in Poland

Portugal2 sites

  • Novartis Investigative Site

    Lisbon, 1649-035

  • Novartis Investigative Site

    Ponte de Lima, 4990-041

Other trials in Portugal

Greece1 site

  • Novartis Investigative Site

    Athens, 115 27

Other trials in Greece

Guatemala1 site

  • Novartis Investigative Site

    Guatemala City, 01010

Other trials in Guatemala

Israel1 site

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Sweden1 site

  • Novartis Investigative Site

    Malmö, 221 85

Other trials in Sweden

About this study

Official title: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Investigate the Efficacy and Safety of Secukinumab 300 mg and 150 mg Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA) (GCAptAIN)

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)

Read the detailed description

Randomized, parallel-group, double-blind, placebo-controlled, multi-center, Phase III study to evaluate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper regimen, in patients with giant cell arteritis (GCA) (GCAptAIN)

Being tested
Secukinumab 300 mg, Placebo, Secukinumab 150 mg
Keywords
GCA, temporal arteritis, giant cell arteritis, vasculitis, secukinumab, monoclonal antibody, AIN457, prednisone taper regimen, glucocorticoid, GC
Medical subject headings
Giant Cell Arteritis, Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Secukinumab 300 mgBiological

    Also called AIN457

    Secukinumab 300 mg

  • PlaceboOther

    Also called Placebo Comparator

    Placebo

  • Secukinumab 150 mgBiological

    Also called AIN457

    Secukinumab

Study groups in NCT04930094
Study groupRoleWhat they receive
Secukinumab 300 mgExperimentalSecukinumab 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.
Receives: Biological: Secukinumab 300 mg
PlaceboPlacebo comparatorPlacebo 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.
Receives: Other: Placebo
Secukinumab 150 mgExperimentalSecukinumab 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.
Receives: Biological: Secukinumab 150 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with sustained remission

    Primary objective is to determine whether the efficacy of secukinumab 300 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week glucocorticoids (GC) taper regimen in participants with giant cell arteritis (GCA) based on sustained remission at Week 52

    Measured: 52 weeks

Secondary outcomes (9)

  1. Cumulative GC Dose

    To demonstrate that the efficacy of secukinumab 300 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen, in participants with GCA, based on cumulative GC dose through Week 52

    Measured: 52 weeks

  2. Proportion of participants with sustained remission

    To demonstrate that the efficacy of secukinumab 150 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen in participants with GCA based on sustained remission at Week 52

    Measured: 52 weeks

  3. Cumulative GC Dose

    To demonstrate that the efficacy of secukinumab 150 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen, in participants with GCA, based on cumulative GC dose through Week 52

    Measured: 52 Weeks

  4. Time to first use of Escape or Rescue Treatment due to GCA as measured in days

    To demonstrate that the efficacy of secukinumab 300 mg s.c. or 150 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen in participants with GCA based on time to first use of Escape Treatment or Rescue Treatment due to GCA

    Measured: 52 weeks

  5. Change in SF-36 score (PCS)

    To demonstrate that the effect on participant's QoL of secukinumab 300 mg s.c. or 150 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen, in participants with GCA based on change of SF-36 score (PCS) at Week 52

    Measured: 52 weeks

  6. Glucocorticoid Toxicity Index (GTI) as measured by the Aggregate Improvement Score (AIS)

    To demonstrate that the effect of secukinumab 300 mg s.c. or 150 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen, in participants with GCA based on Glucocorticoid Toxicity Index (GTI)

    Measured: 52 weeks

  7. Change in FACIT-Fatigue Score

    To demonstrate that the effect on participant's QoL of secukinumab 300 mg s.c. or 150 mg s.c. in combination with a 26-week GC taper regimen is superior to placebo in combination with a 52-week GC taper regimen, in participants with GCA based on change in FACIT-Fatigue score at Week 52

    Measured: 52 weeks

  8. Number of participants with Adverse events (AEs) and Serious AEs (SAEs)

    Number of participants with AEs and SAEs as a measure of safety and tolerability

    Measured: 52 weeks

  9. Number of participants with clinically significant changes in clinical laboratory measures and vital signs

    Number of participants with clinically significant changes in clinical laboratory measures and vital signs, as assessed by the Investigator

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2021
  2. Study start6 Oct 2021
  3. Primary completion11 Apr 2025
  4. Study completion18 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04930094
Sponsor's protocol ID
CAIN457R12301
Other IDs
2024-510744-31-00
Acronym
GCAptAIN
Status last verified
Mar 2026
First submitted
15 Jun 2021
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Stone JH, Venhoff N, Buttgereit F, Dejaco C, Schmidt WA, Spiera R, Blanco R, Rubbert-Roth A, Von Frenckell C, Blockmans D, Terrier B, Tracey G, Hauge EM, Keyport MP, Ng J, Hiremath R, Fu R, Cho G, Bacher G, Thiel J, Mendelson MH. Secukinumab for Giant Cell Arteritis. NEJM Evid. 2026 Jul;5(7):EVIDoa2600112. doi: 10.1056/EVIDoa2600112. Epub 2026 Jun 3.

    PubMed 42234457

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Secukinumab 300 mg and Secukinumab 150 mg in people with Giant Cell Arteritis (GCA), run by Novartis Pharmaceuticals at 104 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in Spain, United States, France, Germany, Australia and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with sustained remission (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04930094, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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