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Trial record 8 of 133 for:    Lupus AND (woman OR women OR female)

Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients

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ClinicalTrials.gov Identifier: NCT02331810
Recruitment Status : Withdrawn
First Posted : January 6, 2015
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

Assess in systemic lupus erythematosus (SLE) patients the effect of SAR113244 on B-cell subsets compared to placebo.

Secondary Objectives:

Assess in male and female lupus patients after SC single dose of SAR113244 the tolerability and safety of SAR113244.

Assess in male and female lupus patients:

  • The pharmacokinetics of SAR113244.
  • The pharmacodynamics of SAR113244 for the following disease 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 (if applicable), Lupus-quality of life and Functional Assessment of Chronic Illness Therapy-Fatigue, anti-double stranded deoxyribonucleic acid antibody and anti-nuclear antibody levels and plasma complement levels (C3, C4), erythrocyte sedimentation rate and C-reactive protein.
    • Peripheral blood B and T cell subsets.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: SAR113244 Drug: placebo Phase 1

Detailed Description:
The total duration of screening to end of study per subject is 16 weeks with post-study observation on Day 198 for anti-drug antibody assessment (for patients with positive anti-drug antibody at end of study only).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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 Patient
Study Start Date : April 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAR113244
Single subcutaneous dose of SAR113244
Drug: SAR113244
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Placebo Comparator: Placebo
Single subcutaneous dose of placebo
Drug: placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous




Primary Outcome Measures :
  1. Percentage decrease in B cell subsets (expressed as percentages of total B-cells) from baseline [ Time Frame: Up to Day 57 after inclusion ]

Secondary Outcome Measures :
  1. Assessment of pharmacokinetic parameter - maximum concentration (Cmax) [ Time Frame: Up to Day 198 after inclusion ]
  2. Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax) [ Time Frame: Up to D198 after inclusion ]
  3. Assessment of pharmacokinetic parameter - area under curve from zero to infinity (AUCinf) [ Time Frame: Up to Day 198 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 Day 85 after inclusion ]
  5. Assessment of pharmacokinetic parameter-apparent oral clearance (CL/F) [ Time Frame: Up to Day 85 after inclusion ]
  6. Assessment of pharmacokinetic parameter- absorption-dependent apparent volume of distribution at steady state (Vss/F) [ Time Frame: Up to Day 85 after inclusion ]
  7. Number of participants with anti-SAR113244 antibody titers [ Time Frame: Up to Day 198 after inclusion ]
  8. Number of participants with adverse events and treatment-emergent adverse events, including those that deviated from baseline values of hematology, biochemistry, coagulation and urine [ Time Frame: Up to Day 198 after inclusion ]
  9. Number of participants with injection site reactions [ Time Frame: Up to Day 85 after inclusion ]
  10. Number of participants with abnormalities and changes in laboratory parameters [ Time Frame: Up to Day 85 after inclusion ]
  11. Assessment of pharmacodynamics - clinical and/or lupus-related scores [ Time Frame: Up to Day 85 after inclusion ]
  12. Assessment of pharmacodynamics - blood/urine parameters [ Time Frame: Up to Day 85 after inclusion ]
  13. Pharmacodynamic parameters: peripheral blood B and T cells subsets [ Time Frame: Up to Day 85 after inclusion ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female patients, between 18 and 75 years of age, inclusive.
  • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
  • Autoantibody-positive.
  • On active and stable SLE disease.
  • B cell subsets expressed as percentage of total B cells above normal.

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, which ever 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 positive 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331810


Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02331810     History of Changes
Other Study ID Numbers: PDY14076
2014-001690-13 ( EudraCT Number )
U1111-1154-6184 ( Other Identifier: UTN )
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases