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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04930094




Registration number
NCT04930094
Ethics application status
Date submitted
15/06/2021
Date registered
18/06/2021

Titles & IDs
Public title
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)
Scientific 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)
Secondary ID [1] 0 0
2024-510744-31-00
Secondary ID [2] 0 0
CAIN457R12301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Giant Cell Arteritis (GCA) 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Secukinumab 300 mg
Other interventions - Placebo
Treatment: Other - Secukinumab 150 mg

Experimental: Secukinumab 300 mg - 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.

Placebo comparator: Placebo - 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.

Experimental: Secukinumab 150 mg - 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.


Treatment: Other: Secukinumab 300 mg
Secukinumab 300 mg

Other interventions: Placebo
Placebo

Treatment: Other: Secukinumab 150 mg
Secukinumab
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with sustained remission
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
Time to clinical failure
Timepoint [1] 0 0
52 weeks
Secondary outcome [2] 0 0
Cumulative GC Dose
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Proportion of participants with sustained remission
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
Time to clinical failure
Timepoint [4] 0 0
52 weeks
Secondary outcome [5] 0 0
Cumulative GC Dose
Timepoint [5] 0 0
52 Weeks
Secondary outcome [6] 0 0
Change in SF-36 score (PCS)
Timepoint [6] 0 0
52 weeks
Secondary outcome [7] 0 0
Change in GlucocorticoidToxicity Index (GTI)
Timepoint [7] 0 0
52 weeks
Secondary outcome [8] 0 0
Change in FACIT-Fatigue Score
Timepoint [8] 0 0
52 weeks
Secondary outcome [9] 0 0
Safety and tolerability of secukinumab
Timepoint [9] 0 0
52 weeks
Secondary outcome [10] 0 0
Safety and tolerability of secukinumab
Timepoint [10] 0 0
52 weeks

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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.
* Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least 6 weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
* Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient
* 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. 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 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 tubal ligation at least six weeks prior to enrollment on 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 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 biologics (e.g., denosumab, TNFa inhibitors) within 4 weeks or within 5 half-lives of the drug (whichever is longer) prior to BSL, or anticipated use of a 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 at screening or randomization (if not treated and cured).
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.
36. Specific for MRI/MRA imaging sub-study: absolute contraindications to MRI/MRA (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator) and to the use of gadolinium-based agents (e.g., people with severe kidney failure, patients with previous severe allergic/anaphylactoid reaction to a gadolinium-based contrast agent); patients with severe renal disease [eGFR <30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)], or acutely deteriorating renal function, who would be at risk of nephrogenic systemic fibrosis. Subjects with renal impairment of a lesser severity may be excluded from the imaging substudy in accordance with local practice.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/07/2027
Actual
Sample size
Target
Accrual to date
Final
354
Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Southport
Recruitment hospital [2] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [3] 0 0
Novartis Investigative Site - Heidelberg Heights
Recruitment hospital [4] 0 0
Novartis Investigative Site - Malvern East
Recruitment hospital [5] 0 0
Novartis Investigative Site - Murdoch
Recruitment hospital [6] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [7] 0 0
Novartis Investigative Site - Parramatta
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
7000 - Hobart
Recruitment postcode(s) [3] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
2170 - Liverpool
Recruitment postcode(s) [7] 0 0
2150 - Parramatta
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Capital Federal
Country [10] 0 0
Austria
State/province [10] 0 0
Graz
Country [11] 0 0
Austria
State/province [11] 0 0
Innsbruck
Country [12] 0 0
Belgium
State/province [12] 0 0
Leuven
Country [13] 0 0
Belgium
State/province [13] 0 0
Liege
Country [14] 0 0
Brazil
State/province [14] 0 0
MG
Country [15] 0 0
Brazil
State/province [15] 0 0
RS
Country [16] 0 0
Brazil
State/province [16] 0 0
SP
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Plovdiv
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Czechia
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Brno Bohunice
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Czechia
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Praha 11
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Czechia
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Praha 2
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Czechia
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Uherske Hradiste
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Denmark
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Aarhus
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Denmark
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Esbjerg
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Denmark
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Vejle
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Estonia
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Tallinn
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Estonia
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Tartu
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Finland
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Helsinki
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Finland
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Kuopio
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Finland
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Lahti
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Finland
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Turku
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France
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Brest
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France
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Dijon
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France
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Le Mans
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France
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Lille
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France
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Marseille
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France
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Nantes Cedex 1
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France
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Paris 13
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France
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Paris
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France
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Strasbourg
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France
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Toulouse
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Germany
State/province [42] 0 0
Berlin
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Germany
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Bonn
Country [44] 0 0
Germany
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Dresden
Country [45] 0 0
Germany
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Erlangen
Country [46] 0 0
Germany
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Freiburg
Country [47] 0 0
Germany
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Herne
Country [48] 0 0
Germany
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Ludwigshafen
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Germany
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Wuerzburg
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Greece
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Athens
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Guatemala
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Guatemala City
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Guatemala
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Guatemala
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Pecs
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Hungary
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Szeged
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Israel
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Tel Aviv
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Italy
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BS
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Italy
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FE
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Italy
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FI
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Italy
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MI
Country [62] 0 0
Italy
State/province [62] 0 0
SI
Country [63] 0 0
Norway
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Gjettum
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Norway
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Moss
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Poland
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Bydgoszcz
Country [66] 0 0
Poland
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Krakow
Country [67] 0 0
Portugal
State/province [67] 0 0
Lisboa
Country [68] 0 0
Portugal
State/province [68] 0 0
Ponte de Lima
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Catalunya
Country [72] 0 0
Spain
State/province [72] 0 0
Galicia
Country [73] 0 0
Spain
State/province [73] 0 0
Navarra
Country [74] 0 0
Spain
State/province [74] 0 0
Pais Vasco
Country [75] 0 0
Spain
State/province [75] 0 0
Madrid
Country [76] 0 0
Spain
State/province [76] 0 0
Valencia
Country [77] 0 0
Sweden
State/province [77] 0 0
Malmo
Country [78] 0 0
Switzerland
State/province [78] 0 0
Basel
Country [79] 0 0
Switzerland
State/province [79] 0 0
Geneve
Country [80] 0 0
Switzerland
State/province [80] 0 0
St Gallen
Country [81] 0 0
Switzerland
State/province [81] 0 0
Zurich
Country [82] 0 0
Turkey
State/province [82] 0 0
Istanbul
Country [83] 0 0
Turkey
State/province [83] 0 0
TUR
Country [84] 0 0
Turkey
State/province [84] 0 0
Ankara
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Staffordshire
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Dundee
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Edinburgh
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04930094