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Trial record 9 of 137 for:    Lupus AND (woman OR women OR female)

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

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ClinicalTrials.gov Identifier: NCT02321709
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

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.

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 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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 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 Patients
Study Start Date : November 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAR113244 cohort 1
Two administrations of dosage 1 SAR113244 or placebo subcutaneous dose (Q4 weeks)
Drug: SAR113244
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Drug: placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Experimental: SAR113244 cohort 2
Two administrations of dosage 2 SAR113244 or placebo subcutaneous dose (Q4 weeks)
Drug: SAR113244
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Drug: placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Experimental: SAR113244 cohort 3
Two administrations of dosage 3 SAR113244 or placebo subcutaneous dose (Q4 weeks)
Drug: SAR113244
Pharmaceutical form:solution for injection Route of administration: subcutaneous

Drug: placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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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 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.


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): NCT02321709


Locations
Germany
Investigational Site Number 276001
Berlin, Germany, 10117
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02321709     History of Changes
Other Study ID Numbers: TDR11407
2014-001690-13 ( EudraCT Number )
U1111-1154-6184 ( Other Identifier: UTN )
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016

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