CompletedNCT02321709Updated May 2, 2016

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

A Phase 1 interventional study of SAR113244 and placebo in Systemic Lupus Erythematosus, sponsored by Sanofi. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-05-02.

Sponsored by Sanofi · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 21
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Read the 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).

Conditions studied

Systemic Lupus Erythematosus

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Lupus Erythematosus, Systemic 1,202

In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 21 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

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Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 21 participants (actual)

Study arms

Experimental
SAR113244 cohort 1
Two administrations of dosage 1 SAR113244 or placebo subcutaneous dose (Q4 weeks)
Drug: SAR113244 · Drug: placebo
Experimental
SAR113244 cohort 2
Two administrations of dosage 2 SAR113244 or placebo subcutaneous dose (Q4 weeks)
Drug: SAR113244 · Drug: placebo
Experimental
SAR113244 cohort 3
Two administrations of dosage 3 SAR113244 or placebo subcutaneous dose (Q4 weeks)
Drug: SAR113244 · Drug: placebo

Interventions

DrugSAR113244
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Drugplacebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous

What researchers measure

Primary outcomes

Number of participants with adverse events and treatment-emergent adverse events
Time frame: Up to 16 weeks after inclusion
Change in physical examination, body weight, vital signs and laboratory parameters
Time frame: Up to 16 weeks after inclusion
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

Assessment of pharmacokinetic parameter - maximum concentration (Cmax)
Time frame: Up to D113 after inclusion
Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax)
Time frame: Up to D113 after inclusion
Assessment of pharmacokinetic parameter - area under curve 0-4 weeks (AUC0-4w)
Time frame: Up to D113 after inclusion
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
Assessment of pharmacokinetic parameter - lowest concentration of drug before the next dose (Ctrough)
Time frame: Up to D113 after inclusion
Assessment of pharmacokinetic parameter - apparent total body clearance (CLss/F)
Time frame: Up to D113 after inclusion
Assessment of pharmacokinetic parameter - absorption-dependent apparent volume of distribution at steady state (Vss/F)
Time frame: Up to D113 after inclusion
Number of participants with anti-SAR113244 antibody titers
Time frame: Up to D226 after inclusion
Pharmacodynamic parameter changes
Time frame: Up to D113 after inclusion
Pharmacodynamic parameters: peripheral blood B and T cells subsets
Time frame: Up to D85 after inclusion

Study locations

1 site

Investigational Site Number 276001
Berlin, 10117, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02321709
Lead sponsor: Sanofi
Responsible party: Sponsor
First posted: Dec 22, 2014
Start date: Nov 2014
Primary completion: Mar 2016
Completion: Mar 2016
Last update: May 2, 2016

Study contacts

Clinical Sciences & Operations

study director · Sanofi

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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