Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Pat… (NCT06130540) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR
United States65 participantsStarted 2024-03-27
Plain-language summary
This study will examine how intravenous (i.v.) Secukinumab will be processed in the body (pharmacokinetics \[PK\]) and whether it will be safe and tolerable after multiple doses of i.v. Secukinumab infusion in adult patients with giant cell arteritis (GCA) or polymyalgia rheumatica (PMR).
Who can participate
Age range50 Years – 100 Years
SexALL
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Inclusion criteria
✓. Male or non-pregnant, non-lactating female participants at least 50 years of age
✓. Diagnosis of GCA based on meeting all of the following criteria:
✓. Active GCA disease within 6 months prior to Baseline as defined by meeting both of the following:
✓. Male or non-pregnant, non-lactating female participants at least 50 years of age
✓. Diagnosis of PMR according to the provisional ACR/EULAR classification criteria: Participants \>= 50 years of age with a history of bilateral shoulder pain accompanied by elevated CRP concentration (\>= 10 mg/L) and/or elevated ESR (\>= 30 mm/hr) who scored at least 4 points from the following optional classification criteria:
✓. Active PMR disease within 6 months prior to Baseline as defined by signs and symptoms attributable to PMR meeting the following:
Exclusion criteria
✕. 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
✕. History of hypersensitivity or contraindication to any of the study treatments or its excipients or to drugs of similar chemical classes
✕. 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
What they're measuring
1
Secukinumab: Maximum concentration at steady state (Cmax,ss)
Timeframe: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime
2
Secukinumab: Minimum concentration at steady state (Cmin,ss)
Timeframe: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime
3
Secukinumab: Area under the concentration-time curve at steady state during a dosing interval (AUCtau,ss)
Timeframe: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime
4
Secukinumab: Average concentration at steady state (Cavg,ss [=AUCtau,ss/tau])
Timeframe: Baseline, Week 4 and Week 8: Pre-dose and End-of Infusion (EOI); Weeks 9, 10, 11, 12, 16 and 20: Anytime
. History of clinically significant liver disease or liver injury as indicated by clinically significantly abnormal liver function tests (LFTs), such as SGOT (AST), SGPT (ALT) and serum bilirubin. The Investigator should be guided by the following criteria:
✕. Active infections or history of ongoing, chronic or recurrent infectious disease including but not limited to below:
✕. Active inflammatory bowel disease or active uveitis
✕. Active ongoing diseases which in the opinion of the Investigator immuno-compromises the participant and/or places the participant at unacceptable risk for treatment with immunomodulatory therapy
✕. Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the trial, including but not limited to below: