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Completed

NCT Number: NCT02321709

Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients

Primary Objective:

To assess the tolerability and safety of SAR113244 in male and female lupus patients after every 4 (Q4) weeks repeated ascending subcutaneous doses of SAR113244.

Secondary Objectives:

To assess in male and female lupus patients:

* The pharmacokinetics of SAR113244. * The pharmacodynamics of SAR113244 for the following disease-related parameters:

* Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index (SRI) (if applicable), Lupus-quality of life (QoL) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, anti-double stranded deoxyribonucleic acid antibody (anti-dsDNA Ab) and anti-nuclear antibody levels (ANA) and plasma complement levels (C3, C4), erythrocyte sedimentation (SED) rate and C-reactive protein. * Peripheral blood B and T cells subsets.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number 276001

Berlin, 10117, Germany

About this study

The total duration of screening to end of study per subject is 20 weeks with post-study observation on Day 226 for anti-drug antibody assessment (for patients with positive anti-drug antibody at end of study only).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients, between 18 and 75 years of age, inclusive.
  • Clinical diagnosis of systemic lupus erythematosus (SLE) by American College Rheumatology criteria.
  • Autoantibody-posititve.
  • On active and stable SLE disease.

Exclusion criteria

  • Pregnant and nursing.
  • Have received treatment with investigational drugs in the 4 months prior to the screening or 5 half-lives of the drug, whichever is longer.
  • Have received intravenous or oral cyclophosphamide within 180 days of Day 0. Severe active lupus nephritis or chronic renal insufficiency.
  • Active or chronic, severe neuropsychiatric lupus.
  • Acute, recent (within 4 weeks of screening), chronic or frequently recurring infection(s), except minor infection.
  • Have current drug or alcohol abuse or dependence.
  • Have a historically positive test or test postitive at screening for HIV, hepatitis B, or hepatitis C.

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

Treatment and study plan

SAR113244

Drug

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Placebo

Drug

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Primary outcomes

  1. Number of participants with adverse events and treatment-emergent adverse events

    Time frame: Up to 16 weeks after inclusion

  2. Change in physical examination, body weight, vital signs and laboratory parameters

    Time frame: Up to 16 weeks after inclusion

  3. Safety and tolerability (erythema, swelling, degree of itching, and present pain intensity at injection site by measuring diameter and qualitative assessment)

    Time frame: Up to 16 weeks after inclusion

Secondary outcomes

  1. Assessment of pharmacokinetic parameter - maximum concentration (Cmax)

    Time frame: Up to D113 after inclusion

  2. Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax)

    Time frame: Up to D113 after inclusion

  3. Assessment of pharmacokinetic parameter - area under curve 0-4 weeks (AUC0-4w)

    Time frame: Up to D113 after inclusion

  4. Assessment of pharmacokinetic parameter - time of the last point with quantifiable concentration (tlast) and terminal elimination half-life (t1/2z)

    Time frame: Up to D113 after inclusion

  5. Assessment of pharmacokinetic parameter - lowest concentration of drug before the next dose (Ctrough)

    Time frame: Up to D113 after inclusion

  6. Assessment of pharmacokinetic parameter - apparent total body clearance (CLss/F)

    Time frame: Up to D113 after inclusion

  7. Assessment of pharmacokinetic parameter - absorption-dependent apparent volume of distribution at steady state (Vss/F)

    Time frame: Up to D113 after inclusion

  8. Number of participants with anti-SAR113244 antibody titers

    Time frame: Up to D226 after inclusion

  9. Pharmacodynamic parameter changes

    Time frame: Up to D113 after inclusion

  10. Pharmacodynamic parameters: peripheral blood B and T cells subsets

    Time frame: Up to D85 after inclusion

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus Patients

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 22, 2014
Registry last updated
May 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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