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Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission (GigAINt)

Primary Purpose

Giant Cell Arteritis

Status
Recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Secukinumab 300 mg, s.c.
Placebo to match Secukinumab, s.c.
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Giant Cell Arteritis focused on measuring Giant Cell Arteritis, GCA, Vasculitis, Vascular Diseases, Secukinumab, Subcutaneous, Vessel Inflammation, Polymyalgia Rheumatica, Arteritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants eligible for inclusion in this study must meet all of the following criteria:

  1. Signed informed consent must be obtained prior to participation in the study.
  2. Participant must be able to understand and communicate with the investigator and comply with the requirements of the study.
  3. Male or female participants at least 50 years of age.
  4. Diagnosis of new-onset GCA, defined as GCA diagnosed within 6 weeks of baseline (BSL) visit, based on meeting all of the following criteria:

    • Age at onset of disease ≥50 years.
    • History of Erythrocyte Sedimentation Rate (ESR) ≥30 mm/hr or C-reactive protein (CRP) ≥10 mg/L attributable to active GCA.
    • Unequivocal cranial symptoms of GCA (new-onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication) AND/OR 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).
    • Temporal artery biopsy revealing features of GCA AND/OR evidence of vasculitis in cranial or extracranial arteries by angiography or cross-sectional imaging study such as ultrasound, magnetic resonance angiography (MRA), computed tomography angiography (CTA), positron emission tomography - computed tomography (PET-CT)
  5. Participants must be in clinical remission at BSL:

    - Definition of clinical remission: absence of signs and symptoms attributable to active GCA as determined by the investigator.

  6. Participants with no relapsing GCA at BSL:

    - Definition of relapsing GCA: occurrence of clinical relapse after clinical remission.

  7. Prednisolone or equivalent dose (oral) of 20-60 mg/day or equivalent dose of other glucocorticoids (GCs) at BSL.

Exclusion Criteria:

Participants meeting any of the following criteria are not eligible for inclusion in this study.

3. Participants not eligible for glucocorticoid monotherapy due to known increased risk for or presence of GC-related adverse-effects or complications and/or intolerance to GCs, such as osteoporosis, diabetes mellitus, cardiovascular disease and glaucoma as assessed at the investigator's discretion (see Appendix 15.2).

4. Previous exposure to secukinumab or another biologic drug directly targeting IL-17 or IL-17 receptor.

5. Participants treated with any cell-depleting therapies including but not limited to anti- CD20 or investigational agents (e.g., anti-CD3, anti-CD4, anti-CD5 or anti-CD19).

6. Previous participation in clinical trials for GCA 7. Participants who have been treated with inhibitors directly targeting IL-12 and/or IL-23 (such as ustekinumab, guselkumab, tildrakizumab, risankizumab), IL-1 or IL-1 receptor (such as anakinra or canakinumab), or abatacept within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL.

8. 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 participant did not respond to or experienced a clinical relapse during treatment any time before BSL.

9. Any treatment received for GCA other than GCs and participant did not respond to treatment or experienced a clinical relapse during treatment any time before BSL.

10. Any other biologics within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL.

11. Participants treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to BSL.

12. Participants treated with cyclophosphamide, tacrolimus, everolimus hydroxychloroquine, cyclosporine A, azathioprine, sulfasalazine, mycophenolate mofetil within 6 months prior to BSL.

13. Participants treated with methotrexate (MTX), within 4 weeks prior to BSL. 14. Participants treated with leflunomide within 8 weeks prior to BSL unless a cholestyramine washout has been performed in which case the participant must be treated within 4 weeks of BSL.

15. Participants treated with an alkylating agent within 5 years prior to Baseline, unless specified in other exclusion criteria.

16. Participants requiring systemic chronic glucocorticoid therapy for any other reason than GCA at Screening.

17. Receipt of > 100 mg daily intravenous methylprednisolone pulse therapy within 6 weeks prior to BSL.

18. Participants requiring chronic (i.e., not occasional "prn") high potency opioid analgesics for pain management.

19. Participants treated with any investigational agent within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL.

20. Contraindication or hypersensitivity to secukinumab. 21. Active ongoing inflammatory diseases other than GCA that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis.

22. Active ongoing diseases which in the opinion of the investigator immunocompromises the participant and/or places the participant at unacceptable risk for treatment with immunomodulatory therapy.

23. Active ongoing inflammatory diseases or underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which in the opinion of the investigator immunocomprises the participant and/or places the participant at unacceptable risk for participation in an immunomodulatory therapy.

24. 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.

25. Confirmed diagnosis of any primary form of systemic vasculitis, other than GCA.

26. Active systemic infections during the last 2 weeks (exception: common cold) prior to BSL.

32. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Plus test. Participants with a positive test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the participant has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment according to local country guidelines must be initiated prior to BSL.

35. Live vaccinations within 6 weeks prior to BSL or planned live vaccination during study participation until 12 weeks after last study treatment administration.

Sites / Locations

  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Secukinumab

Arm Description

Participants will receive placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.

Participants will receive secukinumab as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.

Outcomes

Primary Outcome Measures

Time from baseline to first Giant cell arteritis (GCA) clinical relapse
To demonstrate the superiority of secukinumab 300 mg s.c. compared to placebo (both arms in combination with a prednisolone or equivalent taper regimen as per treatment guideline) in delaying the time to first GCA clinical relapse from baseline in participants with new onset of GCA who are in clinical remission and eligible for treatment with glucocorticoid-monotherapy. GCA clinical relapse is defined as both: The recurrence of signs or symptoms attributable to active GCA after clinical remission, which are considered clinically significant by the investigator AND The requirement of a change in the treatment prompted by the recurrence of signs and symptoms i. an increase in prednisolone or equivalent dose AND/OR ii. the addition of a rescue treatment. Definition of clinical remission: absence of signs and symptoms attributable to active GCA as determined by the investigator.

Secondary Outcome Measures

Proportion of participants in sustained clinical remission at Week 52
To demonstrate the superiority of secukinumab 300 mg s.c. compared to placebo, measured by the proportion of participants in sustained clinical remission at Week 52. Definition of sustained clinical remission: absence of signs and symptoms attributable to active GCA between BSL until Week 52.
Changes from Baseline to Week 52 in disease activity and quality of life for the PGA score (VAS)
To assess the effect of secukinumab compared to placebo measured by disease activity and quality of life measures at Week 52 for patient global assessment (PGA) of disease activity using a visual analogue scale (VAS)
Changes from Baseline to Week 52 in disease activity and quality of life for the SF-36 (PCS and MCS) score
To assess the effect of secukinumab compared to placebo measured by disease activity and quality of life measures at Week 52 for Short form 36 (SF-36 PCS and MCS)
Changes from Baseline to Week 52 in disease activity and quality of life for Patient assessment of pain (NRS)
To assess the effect of secukinumab compared to placebo measured by disease activity and quality of life measures at Week 52 for patient assessment of pain using a numeric rating scale (NRS)
Time from Baseline to reach prednisolone or equivalent dose below ≤7.5 mg/day
Time to reach prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day
Proportion of participants on prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day
Proportion of participants on prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day
Cumulative prednisolone or equivalent dose
Cumulative prednisolone or equivalent dose through Week 52
Number of participants with Adverse Events
Safety and tolerability assessments over time: incidence and severity of AEs and SAEs; routine safety laboratory parameters To evaluate safety and tolerability of secukinumab 300 mg s.c. in participants with new-onset of GCA who are eligible for treatment with glucocorticoid-monotherapy

Full Information

First Posted
February 22, 2022
Last Updated
October 20, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05380453
Brief Title
Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission
Acronym
GigAINt
Official Title
A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Efficacy and Safety of Subcutaneously Administered Secukinumab in Patients With New-onset of Giant Cell Arteritis (GCA) Who Are in Clinical Remission and Eligible for Treatment With Glucocorticoid-monotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
November 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of subcutaneously (s.c.) administered secukinumab 300 mg in combination with glucocorticoid taper regimen compared to placebo in combination with glucocorticoid taper regimen, in adult patients with new onset of giant cell arteritis (GCA) who are in clinical remission and who are eligible for treatment with glucocorticoid-monotherapy as per current clinical practice and treatment guidelines for the targeted participant population, thereby supporting health technology assessments (HTAs) of secukinumab in Germany.
Detailed Description
Recent scientific evidence identified an association between polymorphisms within the IL-17A locus and GCA, supporting a role for IL-17A in vasculitis pathophysiology. Analysis of the inflammatory processes in the aortic wall has indicated that inflammatory cytokines, such as IL-6 and IL-17A are involved in GCA pathogenesis. Elevated IL-17A mRNA levels are correlated with IL-6 and IL-23p19 mRNA levels indicating the involvement of the IL-23/Th17 axis in GCA. With its pleiotropic activity on many different cell types, IL-17A may actively contribute to the inflammatory processes in GCA. In addition, animal studies also support a role of IL-17A as a driver of vasculitis, since mice deficient in IRF-4 binding protein, which have increased IL-21 and IL-17A expression, spontaneously develop arthritis-like joint disease and large vessel vasculitis (LVV). As secukinumab has already demonstrated a positive benefit/risk profile in the treatment of multiple chronic inflammatory diseases, including PsO, PsA and axSpA, and based on the scientific rationale for targeting the IL-17 pathway in GCA as well as on the basis of the currently ongoing Phase 2 Proof-of-Concept trial the which evaluates the efficacy, safety and tolerability of 300 mg secukinumab compared to placebo, in combination with a 26-week prednisolone taper regimen in adult subjects with GCA (EudraCT number: 2018-002610-12) (Venhoff, et al., 2021), inhibition of IL-17A by secukinumab has a potential therapeutic benefit for GCA patients. The purpose of this study is to demonstrate the efficacy and safety of subcutaneously (s.c.) administered secukinumab 300 mg in combination with glucocorticoid taper regimen compared to placebo in combination with glucocorticoid taper regimen, in adult patients with new onset of giant cell arteritis (GCA) who are in clinical remission and who are eligible for treatment with glucocorticoid-monotherapy as per current clinical practice and treatment guidelines for the targeted participant population, thereby supporting health technology assessments (HTAs) of secukinumab in Germany.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Arteritis
Keywords
Giant Cell Arteritis, GCA, Vasculitis, Vascular Diseases, Secukinumab, Subcutaneous, Vessel Inflammation, Polymyalgia Rheumatica, Arteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.
Arm Title
Secukinumab
Arm Type
Experimental
Arm Description
Participants will receive secukinumab as subcutaneous (s.c.) injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.
Intervention Type
Biological
Intervention Name(s)
Secukinumab 300 mg, s.c.
Other Intervention Name(s)
Cosentyx, AIN457
Intervention Description
Secukinumab will be administered at a dose of 300 mg as s.c. injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.
Intervention Type
Drug
Intervention Name(s)
Placebo to match Secukinumab, s.c.
Intervention Description
Placebo will be administered as s.c. injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter.
Primary Outcome Measure Information:
Title
Time from baseline to first Giant cell arteritis (GCA) clinical relapse
Description
To demonstrate the superiority of secukinumab 300 mg s.c. compared to placebo (both arms in combination with a prednisolone or equivalent taper regimen as per treatment guideline) in delaying the time to first GCA clinical relapse from baseline in participants with new onset of GCA who are in clinical remission and eligible for treatment with glucocorticoid-monotherapy. GCA clinical relapse is defined as both: The recurrence of signs or symptoms attributable to active GCA after clinical remission, which are considered clinically significant by the investigator AND The requirement of a change in the treatment prompted by the recurrence of signs and symptoms i. an increase in prednisolone or equivalent dose AND/OR ii. the addition of a rescue treatment. Definition of clinical remission: absence of signs and symptoms attributable to active GCA as determined by the investigator.
Time Frame
Time from baseline to first GCA clinical relapse, assessed at least up to Week 24
Secondary Outcome Measure Information:
Title
Proportion of participants in sustained clinical remission at Week 52
Description
To demonstrate the superiority of secukinumab 300 mg s.c. compared to placebo, measured by the proportion of participants in sustained clinical remission at Week 52. Definition of sustained clinical remission: absence of signs and symptoms attributable to active GCA between BSL until Week 52.
Time Frame
Baseline until Week 52
Title
Changes from Baseline to Week 52 in disease activity and quality of life for the PGA score (VAS)
Description
To assess the effect of secukinumab compared to placebo measured by disease activity and quality of life measures at Week 52 for patient global assessment (PGA) of disease activity using a visual analogue scale (VAS)
Time Frame
Baseline to Week 52
Title
Changes from Baseline to Week 52 in disease activity and quality of life for the SF-36 (PCS and MCS) score
Description
To assess the effect of secukinumab compared to placebo measured by disease activity and quality of life measures at Week 52 for Short form 36 (SF-36 PCS and MCS)
Time Frame
Baseline to Week 52
Title
Changes from Baseline to Week 52 in disease activity and quality of life for Patient assessment of pain (NRS)
Description
To assess the effect of secukinumab compared to placebo measured by disease activity and quality of life measures at Week 52 for patient assessment of pain using a numeric rating scale (NRS)
Time Frame
Baseline to Week 52
Title
Time from Baseline to reach prednisolone or equivalent dose below ≤7.5 mg/day
Description
Time to reach prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day
Time Frame
Baseline to Week 52
Title
Proportion of participants on prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day
Description
Proportion of participants on prednisolone or equivalent dose below Cushing threshold of ≤7.5 mg/day
Time Frame
Bseline to Week 52
Title
Cumulative prednisolone or equivalent dose
Description
Cumulative prednisolone or equivalent dose through Week 52
Time Frame
Baseline through Week 52
Title
Number of participants with Adverse Events
Description
Safety and tolerability assessments over time: incidence and severity of AEs and SAEs; routine safety laboratory parameters To evaluate safety and tolerability of secukinumab 300 mg s.c. in participants with new-onset of GCA who are eligible for treatment with glucocorticoid-monotherapy
Time Frame
Baseline up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: Signed informed consent must be obtained prior to participation in the study. Participant must be able to understand and communicate with the investigator and comply with the requirements of the study. Male or female participants at least 50 years of age. Diagnosis of new-onset GCA, defined as GCA diagnosed within 6 weeks of baseline (BSL) visit, based on meeting all of the following criteria: Age at onset of disease ≥50 years. History of Erythrocyte Sedimentation Rate (ESR) ≥30 mm/hr or C-reactive protein (CRP) ≥10 mg/L attributable to active GCA. Unequivocal cranial symptoms of GCA (new-onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication) AND/OR 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). Temporal artery biopsy revealing features of GCA AND/OR evidence of vasculitis in cranial or extracranial arteries by angiography or cross-sectional imaging study such as ultrasound, magnetic resonance angiography (MRA), computed tomography angiography (CTA), positron emission tomography - computed tomography (PET-CT) Participants must be in clinical remission at BSL: - Definition of clinical remission: absence of signs and symptoms attributable to active GCA as determined by the investigator. Participants with no relapsing GCA at BSL: - Definition of relapsing GCA: occurrence of clinical relapse after clinical remission. Prednisolone or equivalent dose (oral) of 20-60 mg/day or equivalent dose of other glucocorticoids (GCs) at BSL. Exclusion Criteria: Participants meeting any of the following criteria are not eligible for inclusion in this study. 3. Participants not eligible for glucocorticoid monotherapy due to known increased risk for or presence of GC-related adverse-effects or complications and/or intolerance to GCs, such as osteoporosis, diabetes mellitus, cardiovascular disease and glaucoma as assessed at the investigator's discretion (see Appendix 15.2). 4. Previous exposure to secukinumab or another biologic drug directly targeting IL-17 or IL-17 receptor. 5. Participants treated with any cell-depleting therapies including but not limited to anti- CD20 or investigational agents (e.g., anti-CD3, anti-CD4, anti-CD5 or anti-CD19). 6. Previous participation in clinical trials for GCA 7. Participants who have been treated with inhibitors directly targeting IL-12 and/or IL-23 (such as ustekinumab, guselkumab, tildrakizumab, risankizumab), IL-1 or IL-1 receptor (such as anakinra or canakinumab), or abatacept within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL. 8. 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 participant did not respond to or experienced a clinical relapse during treatment any time before BSL. 9. Any treatment received for GCA other than GCs and participant did not respond to treatment or experienced a clinical relapse during treatment any time before BSL. 10. Any other biologics within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL. 11. Participants treated with i.v. immunoglobulins or plasmapheresis within 8 weeks prior to BSL. 12. Participants treated with cyclophosphamide, tacrolimus, everolimus hydroxychloroquine, cyclosporine A, azathioprine, sulfasalazine, mycophenolate mofetil within 6 months prior to BSL. 13. Participants treated with methotrexate (MTX), within 4 weeks prior to BSL. 14. Participants treated with leflunomide within 8 weeks prior to BSL unless a cholestyramine washout has been performed in which case the participant must be treated within 4 weeks of BSL. 15. Participants treated with an alkylating agent within 5 years prior to Baseline, unless specified in other exclusion criteria. 16. Participants requiring systemic chronic glucocorticoid therapy for any other reason than GCA at Screening. 17. Receipt of > 100 mg daily intravenous methylprednisolone pulse therapy within 6 weeks prior to BSL. 18. Participants requiring chronic (i.e., not occasional "prn") high potency opioid analgesics for pain management. 19. Participants treated with any investigational agent within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL. 20. Contraindication or hypersensitivity to secukinumab. 21. Active ongoing inflammatory diseases other than GCA that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis. 22. Active ongoing diseases which in the opinion of the investigator immunocompromises the participant and/or places the participant at unacceptable risk for treatment with immunomodulatory therapy. 23. Active ongoing inflammatory diseases or underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which in the opinion of the investigator immunocomprises the participant and/or places the participant at unacceptable risk for participation in an immunomodulatory therapy. 24. 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. 25. Confirmed diagnosis of any primary form of systemic vasculitis, other than GCA. 26. Active systemic infections during the last 2 weeks (exception: common cold) prior to BSL. 32. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Plus test. Participants with a positive test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the participant has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment according to local country guidelines must be initiated prior to BSL. 35. Live vaccinations within 6 weeks prior to BSL or planned live vaccination during study participation until 12 weeks after last study treatment administration.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Bad Abbach
ZIP/Postal Code
93077
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bad Doberan
ZIP/Postal Code
18209
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12435
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gommern
ZIP/Postal Code
39245
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Halle Saale
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Herne
ZIP/Postal Code
44649
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jena
ZIP/Postal Code
07740
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
51149
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rendsburg
ZIP/Postal Code
24768
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Trier
ZIP/Postal Code
54292
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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

Learn more about this trial

Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission

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