Systemic Lupus ErythematosusPhase 1NCT02331810
Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients
A Phase 1 study testing SAR113244 in people with Systemic Lupus Erythematosus, run by Sanofi.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- SAR113244
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to May 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
Primary Objective:
Assess in systemic lupus erythematosus (SLE) patients the effect of SAR113244 on B-cell subsets compared to placebo.
Read more
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.
Read the 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).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- SAR113244, placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR113244Drug
Pharmaceutical form:solution for injection Route of administration: subcutaneous
placeboDrug
Pharmaceutical form:solution for injection Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| SAR113244 | Experimental | Single subcutaneous dose of SAR113244 Receives: Drug: SAR113244 |
| Placebo | Placebo comparator | Single subcutaneous dose of placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage decrease in B cell subsets (expressed as percentages of total B-cells) from baseline
Measured: Up to Day 57 after inclusion
Secondary outcomes (13)
Assessment of pharmacokinetic parameter - maximum concentration (Cmax)
Measured: Up to Day 198 after inclusion
Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax)
Measured: Up to D198 after inclusion
Assessment of pharmacokinetic parameter - area under curve from zero to infinity (AUCinf)
Measured: Up to Day 198 after inclusion
Assessment of pharmacokinetic parameter - time of the last point with quantifiable concentration (tlast) and terminal elimination half-life (t1/2z)
Measured: Up to Day 85 after inclusion
Assessment of pharmacokinetic parameter-apparent oral clearance (CL/F)
Measured: Up to Day 85 after inclusion
Assessment of pharmacokinetic parameter- absorption-dependent apparent volume of distribution at steady state (Vss/F)
Measured: Up to Day 85 after inclusion
Number of participants with anti-SAR113244 antibody titers
Measured: Up to Day 198 after inclusion
Number of participants with adverse events and treatment-emergent adverse events, including those that deviated from baseline values of hematology, biochemistry, coagulation and urine
Measured: Up to Day 198 after inclusion
Number of participants with injection site reactions
Measured: Up to Day 85 after inclusion
Number of participants with abnormalities and changes in laboratory parameters
Measured: Up to Day 85 after inclusion
Assessment of pharmacodynamics - clinical and/or lupus-related scores
Measured: Up to Day 85 after inclusion
Assessment of pharmacodynamics - blood/urine parameters
Measured: Up to Day 85 after inclusion
Pharmacodynamic parameters: peripheral blood B and T cells subsets
Measured: Up to Day 85 after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startApr 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331810
- Sponsor's protocol ID
- PDY14076
- Other IDs
- 2014-001690-13, U1111-1154-6184, 2014
- Status last verified
- Jun 2016
- First submitted
- 5 Dec 2014
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02331810
- Acronym / sponsor ID
- PDY14076
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR113244 | Experimental | Drug: SAR113244Single subcutaneous dose of SAR113244 |
| Placebo | Placebo comparator | Drug: placeboSingle subcutaneous dose of placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR113244Pharmaceutical form:solution for injection Route of administration: subcutaneous | Drug | SAR113244 |
| placeboPharmaceutical form:solution for injection Route of administration: subcutaneous | Drug | Placebo |
Primary outcome
Percentage decrease in B cell subsets (expressed as percentages of total B-cells) from baseline
Time frame: Up to Day 57 after inclusion
13 secondary outcomes
Assessment of pharmacokinetic parameter - maximum concentration (Cmax)
Time frame: Up to Day 198 after inclusion
Assessment of pharmacokinetic parameter - time of maximum concentration (Tmax)
Time frame: Up to D198 after inclusion
Assessment of pharmacokinetic parameter - area under curve from zero to infinity (AUCinf)
Time frame: Up to Day 198 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 Day 85 after inclusion
Assessment of pharmacokinetic parameter-apparent oral clearance (CL/F)
Time frame: Up to Day 85 after inclusion
Assessment of pharmacokinetic parameter- absorption-dependent apparent volume of distribution at steady state (Vss/F)
Time frame: Up to Day 85 after inclusion
Number of participants with anti-SAR113244 antibody titers
Time frame: Up to Day 198 after inclusion
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
Number of participants with injection site reactions
Time frame: Up to Day 85 after inclusion
Number of participants with abnormalities and changes in laboratory parameters
Time frame: Up to Day 85 after inclusion
Assessment of pharmacodynamics - clinical and/or lupus-related scores
Time frame: Up to Day 85 after inclusion
Assessment of pharmacodynamics - blood/urine parameters
Time frame: Up to Day 85 after inclusion
Pharmacodynamic parameters: peripheral blood B and T cells subsets
Time frame: Up to Day 85 after inclusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR113244 in people with Systemic Lupus Erythematosus, run by Sanofi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage decrease in B cell subsets (expressed as percentages of total B-cells) from baseline (time frame: Up to Day 57 after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.