Sarilumab Effect on the Pharmacokinetics of Simvastatin

• Register: ClinicalTrials.gov
• Last refreshed on: 18 April 2016
• Main ID: NCT02017639
• Date of registration: 02/12/2013
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Sarilumab Effect on the Pharmacokinetics of Simvastatin
• Scientific title: A Multi-center, Open-label, 2-treatment, Single-sequence Clinical Study to Evaluate the Effects of a Single 200 mg Subcutaneous Injection of Sarilumab on the Pharmacokinetics of a Single 40 mg Oral Dose of Simvastatin, With Optional 1-year Extension of Open Label Treatment of Sarilumab, in Patients With Rheumatoid Arthritis
• Date of first enrolment: January 2014
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02017639
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
• Phase: Phase 1

Countries of recruitment

Korea, Republic of, Moldova, Republic of, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria:

Male or female, between 18 and 75 years of age, inclusive. Body weight between 50.0 and
120.0 kg, inclusive, if male, and between 40.0 and 110.0 kg, inclusive, if female.

Diagnosis of RA, according to the ACR/European League against Rheumatism (EULAR) 2010
Rheumatoid Arthritis Classification Criteria with = 3 months disease duration, ACR Class
I-III functional status, based on 1991 revised criteria (Appendix B, 5).
Moderate-to-severely active RA, defined as:

o high sensitivity C-reactive protein (hs-CRP) = 6 mg/L

Laboratory parameters within the normal range (or defined screening threshold for the
Investigator site), unless the Investigator considers an abnormality to be clinically
irrelevant for RA patients; however following lab values must be met:

- Hemoglobin >8.5 g/dL

- White blood cells >3000/mm3

- Neutrophils >2000/mm3

- Platelet count >150 000 cells/mm3

Exclusion criteria:

Prior or current significant concomitant illness(es) that, according to Investigator's
judgment, would adversely affect the patient's participation in the study.

Women of childbearing potential not protected by highly-effective contraceptive method(s)
of birth control (as defined in the informed consent form), and/or who are unwilling or
unable to be tested for pregnancy.

Participation in any clinical research study that evaluated an investigational drug or
therapy within 5 half-lives or 60 days of the Screening, whichever is longer.

Patients with active TB or a history of incompletely treated TB. History of chronic
infection or active infection. History of, or current, autoimmune or inflammatory systemic
or localized joint disease(s) other than RA.

A systemic hypersensitivity reaction, other than localized injection site reaction, to any
biologic drug.

History or presence of drug or alcohol abuse. Prior or current interstitial lung disease
diagnosed by high resolution computed tomography and/or lung biopsy with consistent
findings on pulmonary function tests and corroborating clinical findings.

Prior or current history of malignancy, including lymphoproliferative diseases, other than
adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal
cell carcinoma of the skin, within 5 years prior to the screening visit.

Uncontrolled diabetes mellitus, defined as glycosylated hemoglobin (HbA1c) =9% at the
screening visit.

Current treatment with anti-TNF agents or other biologics. Current treatment with
RA-directed biologic agents with non- TNF-a antagonist. Any contra-indications to
simvastatin, according to the applicable labeling. Current treatment with a statin within
14 days before inclusion.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: sarilumab SAR153191 (REGN88)

Drug: simvastatin

Primary Outcome(s)

Assessment of PK parameters - area under curve from zero time until the last measurable concentration (AUClast) and AUC for simvastatin [Time Frame: Day 1 of Period 1 and Day 8 of Period 2]

Secondary Outcome(s)

Safety assessment of sarilumab up to 1 year ) [Time Frame: From Day 1 of Period 1 up to a maximum of 1 year (week 58)]

Assessment of additional PK parameters for simvastatin [Time Frame: Day 1 of Period 1 and Day 8 of Period 2]

Assessment of additional PK parameters for simvastatin acid [Time Frame: Day 1 of Period 1 and Day 8 of Period 2]

Secondary ID(s)

U1111-1140-5082

INT12684

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals