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

NCT04930094 | Completed Phase 3 FDA Drug

• 2 other identifiers: CAIN457R123012024-510744-31-00
• Study Type: interventional
• Target: 354
• Locations: 25 countries
• Sites: 95

Brief 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)

Conditions

Giant Cell Arteritis (GCA)

Keywords

GCA; temporal arteritis; giant cell arteritis; vasculitis; secukinumab; monoclonal antibody; AIN457; prednisone taper regimen; glucocorticoid; GC

Outcome Measures

Primary Outcomes (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

  52 weeks

Secondary Outcomes (9)

• Cumulative GC Dose

  52 weeks

• Proportion of participants with sustained remission

  52 weeks

• Cumulative GC Dose

  52 Weeks

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

  52 weeks

• Change in SF-36 score (PCS)

  52 weeks

Study Arms (3)

Secukinumab 300 mg

EXPERIMENTAL

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.

Biological: Secukinumab 300 mg

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Secukinumab 150 mg

EXPERIMENTAL

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.

Biological: Secukinumab 150 mg

Interventions

Secukinumab 300 mg BIOLOGICAL

Secukinumab 300 mg

Also known as: AIN457

Secukinumab 300 mg

Placebo OTHER

Placebo

Also known as: Placebo Comparator

Placebo

Secukinumab 150 mg BIOLOGICAL

Secukinumab

Also known as: AIN457

Secukinumab 150 mg

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (104)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

IRIS Research and Development

Plantation, Florida, 33324, United States

Location

Sarasota Arthritis Res Ctr

Sarasota, Florida, 34239, United States

Location

Novartis Investigative Site

Iowa City, Iowa, 52242, United States

Location

University Of Iowa

Iowa City, Iowa, 52242, United States

Location

Osteoporosis and Clinical Trial Ctr

Hagerstown, Maryland, 21740, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Precision Comp Clin Research

Grapevine, Texas, 76051, United States

Location

Advanced Rheumatology of Houston

Spring, Texas, 77382, United States

Location

Novartis Investigative Site

La Plata, Buenos Aires, B1900AWT, Argentina

Location

Novartis Investigative Site

Capital Federal, C1023AAB, Argentina

Location

Novartis Investigative Site

Parramatta, New South Wales, 2150, Australia

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Novartis Investigative Site

Southport, Queensland, 4215, Australia

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Novartis Investigative Site

Hobart, Tasmania, 7000, Australia

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Novartis Investigative Site

Heidelberg Heights, Victoria, 3081, Australia

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Novartis Investigative Site

Malvern East, Victoria, 3145, Australia

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Novartis Investigative Site

Murdoch, Western Australia, 6150, Australia

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Novartis Investigative Site

Liverpool, 2170, Australia

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Novartis Investigative Site

Innsbruck, Tyrol, 6020, Austria

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Novartis Investigative Site

Graz, 8036, Austria

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Novartis Investigative Site

Leuven, 3000, Belgium

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Novartis Investigative Site

Liège, 4000, Belgium

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Novartis Investigative Site

Juiz de Fora, Minas Gerais, 36010 570, Brazil

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Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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Novartis Investigative Site

Sao Jose Rio Preto, São Paulo, 15090 000, Brazil

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Novartis Investigative Site

Plovdiv, 4000, Bulgaria

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Novartis Investigative Site

Plovdiv, 4002, Bulgaria

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Novartis Investigative Site

Montreal, Quebec, H1T 2M4, Canada

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Novartis Investigative Site

Sherbrooke, Quebec, J1G 2E8, Canada

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Novartis Investigative Site

Trois-Rivières, Quebec, G9A 3X2, Canada

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Novartis Investigative Site

Brno, 625 00, Czechia

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Novartis Investigative Site

Prague, 128 00, Czechia

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Novartis Investigative Site

Prague, 148 00, Czechia

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Novartis Investigative Site

Uherské Hradiště, 686 01, Czechia

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Novartis Investigative Site

Aarhus N, 8200, Denmark

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Novartis Investigative Site

Esbjerg, 6700, Denmark

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Novartis Investigative Site

Vejle, DK-7100, Denmark

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Novartis Investigative Site

Tallinn, 10138, Estonia

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Novartis Investigative Site

Tartu, 50708, Estonia

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Novartis Investigative Site

Helsinki, 00290, Finland

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Novartis Investigative Site

Kuopio, 70100, Finland

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Novartis Investigative Site

Lahti, 15850, Finland

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Novartis Investigative Site

Turku, 20520, Finland

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Novartis Investigative Site

Brest, 29200, France

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Novartis Investigative Site

Dijon, 21000, France

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Novartis Investigative Site

Le Mans, 72000, France

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Novartis Investigative Site

Lille, 59037, France

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Marseille, 13008, France

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Novartis Investigative Site

Nantes, 44093, France

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Novartis Investigative Site

Paris, 75013, France

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Novartis Investigative Site

Paris, 75014, France

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Novartis Investigative Site

Strasbourg, 67000, France

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Novartis Investigative Site

Toulouse, 31059, France

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Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Novartis Investigative Site

Würzburg, Bavaria, 97080, Germany

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Dresden, Saxony, 01307, Germany

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Berlin, 13125, Germany

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Bonn, 53105, Germany

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Dresden, 01067, Germany

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Novartis Investigative Site

Erlangen, 91054, Germany

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Novartis Investigative Site

Herne, 44649, Germany

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Novartis Investigative Site

Ludwigshafen, 67063, Germany

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Novartis Investigative Site

Athens, 115 27, Greece

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Guatemala City, 01010, Guatemala

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Novartis Investigative Site

Pécs, Baranya, 7623, Hungary

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Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, 4032, Hungary

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Budapest, H-1083, Hungary

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Szeged, 6725, Hungary

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Novartis Investigative Site

Tel Aviv, 6423906, Israel

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Novartis Investigative Site

Brescia, BS, 25123, Italy

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Novartis Investigative Site

Cona, FE, 44124, Italy

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Novartis Investigative Site

Florence, FI, 50134, Italy

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Novartis Investigative Site

Milan, MI, 20132, Italy

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Novartis Investigative Site

Siena, SI, 53100, Italy

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Novartis Investigative Site

Gjettum, 1346, Norway

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Novartis Investigative Site

Moss, 1538, Norway

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Novartis Investigative Site

Bydgoszcz, 85-168, Poland

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Novartis Investigative Site

Krakow, 30-002, Poland

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Novartis Investigative Site

Lisbon, 1649-035, Portugal

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Novartis Investigative Site

Ponte de Lima, 4990-041, Portugal

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Novartis Investigative Site

Santiago Compostela, A Coruna, 15706, Spain

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Novartis Investigative Site

Badalona, Barcelona, 08916, Spain

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Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

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Novartis Investigative Site

Bilbao, Bizkaia, 48013, Spain

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Novartis Investigative Site

Santander, Cantabria, 39008, Spain

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Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

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Novartis Investigative Site

Barcelona, 08036, Spain

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Novartis Investigative Site

Barcelona, 08041, Spain

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Novartis Investigative Site

Madrid, 28009, Spain

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Novartis Investigative Site

Madrid, 28046, Spain

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Valencia, 46026, Spain

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Novartis Investigative Site

Malmo, 221 85, Sweden

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Novartis Investigative Site

Basel, 4031, Switzerland

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Novartis Investigative Site

Geneva, 1211, Switzerland

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Novartis Investigative Site

Sankt Gallen, 9007, Switzerland

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Novartis Investigative Site

Zurich, 8091, Switzerland

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Novartis Investigative Site

Istanbul, Fatih, 34098, Turkey (Türkiye)

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Novartis Investigative Site

Istanbul, Pendik, 34899, Turkey (Türkiye)

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Novartis Investigative Site

Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

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Novartis Investigative Site

Edinburgh, Scotland, EH4 2XU, United Kingdom

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Novartis Investigative Site

Stoke-on-Trent, Staffordshire, ST6 7AG, United Kingdom

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Novartis Investigative Site

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

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Novartis Investigative Site

Dundee, DD1 9SY, United Kingdom

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MeSH Terms

Conditions

Giant Cell Arteritis; Vasculitis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 18, 2021
• Study Start: October 6, 2021
• Primary Completion: April 11, 2025
• Study Completion: February 18, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GR (1); DE (9); FI (4); IL (1); CH (4); BE (2); US (10); AU (2); CZ (4); ES (11); HU (4); BR (3); BU (2); CA (3); PL (2); IT (5); PT (2); NO (2); AR (2); DK (3); SE (1); GU (1); TU (3); FR (10); GB (4)