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Lupus ErythematosusPhase 1NCT01686555

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)

A Phase 1 study testing ABT-199 in people with Lupus Erythematosus, run by AbbVie (prior sponsor, Abbott) at 15 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Lupus Erythematosus
What is being tested?
ABT-199
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
97 participants
Where
15 sitesin 4 countries
Study dates
Nov 2012to Jun 2015
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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of systemic lupus erythematosus for at least 6 months.
  • Documentation of at least one of the following: ANA titer >= 1:160 or positive anti-dsDNA antibodies.
  • Stable systemic lupus erythematosus medication regimen.
  • Other than systemic lupus erythematosus, subject should be in general good health.

Who cannot join

  • Male.
  • Drug-induced or highly active systemic lupus erythematosus.
  • Significant autoimmune disease other than lupus.
  • Significant, uncontrolled or unstable disease in any organ.

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

United States11 sites

  • Site Reference ID/Investigator# 89694

    Clearwater, Florida, 33765

  • Site Reference ID/Investigator# 123335

    Dallas, Texas, 75231

  • Site Reference ID/Investigator# 78253

    Dallas, Texas, 75231

  • Site Reference ID/Investigator# 131720

    DeBary, Florida, 32713

  • Site Reference ID/Investigator# 78254

    Duncansville, Pennsylvania, 16635

  • Site Reference ID/Investigator# 89773

    Manhasset, New York, 11030

  • Site Reference ID/Investigator# 118637

    Miami, Florida, 33136

  • Site Reference ID/Investigator# 124116

    Miami Lakes, Florida, 33016

  • Site Reference ID/Investigator# 89693

    Orlando, Florida, 32806

  • Site Reference ID/Investigator# 78256

    Overland Park, Kansas, 66212

  • Site Reference ID/Investigator# 129826

    Rochester, Minnesota, 55905

Other trials in United States

Mexico2 sites

  • Site Reference ID/Investigator# 116395

    Distrito Federal, CP 14050

  • Site Reference ID/Investigator# 112555

    Monterrey, C.P. 64000

Other trials in Mexico

Germany1 site

  • Site Reference ID/Investigator# 107896

    Berlin, 10117

Other trials in Germany

Puerto Rico1 site

  • Site Reference ID/Investigator# 132009

    San Juan, 00909-3004

Other trials in Puerto Rico

About this study

Official title: Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)

To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.

Read the detailed description

This is a phase 1, randomized, double-blind, placebo-controlled, single-and multiple ascending dose study. Up to eighty-eight subjects with Systemic Lupus Erythematosus will be selected to participate. Subjects will be randomized to receive either ABT-199 or placebo. Subjects will be administered ABT-199/placebo as a single dose or up to 14 days as multiple doses.

Being tested
ABT-199, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-199Drug

    Tablet

  • PlaceboOther

    Tablet

Study groups in NCT01686555
Study groupRoleWhat they receive
Single DoseExperimentalSubjects enrolled in the Single Ascending Dose (SAD) part of the study will receive a single dose of study drug or placebo. (Groups 1, 2, 3, 4, 5 and 6).
Receives: Drug: ABT-199; Other: Placebo
Multiple DoseExperimentalSubjects enrolled in the Multiple Ascending Dose (MAD) part of the study will receive multiple doses of study drug or placebo. (Groups 7, 8, 9, 10 and 11)
Receives: Drug: ABT-199; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Adverse Events

    Collect all adverse events at each visit

    Measured: From first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199

  2. Physical Exam including vital signs

    Blood pressure, heart rate and body temperature

    Measured: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199

  3. Clinical Lab Testing

    Hematology, Chemistry, and Urinalysis

    Measured: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199

  4. Electrocardiogram (ECG) Measurements

    ECGs done in triplicate

    Measured: For 24 hours after a single dose of ABT-199 and up to 24 hours after the seventh dose of multiple doses of ABT-199

  5. Maximum observed serum concentration (Cmax) of ABT-199

    Cmax

    Measured: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199

  6. Time to Cmax (Tmax) of ABT-199

    Time to Cmax

    Measured: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199

  7. The area under the time curve (AUC) of ABT-199

    the area under the exposure-time curve of ABT-199 extrapolated to infinite time for single doses and up to 24 hrs for multiple doses of ABT-199

    Measured: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199

  8. The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199

    The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199

    Measured: For 72 hours after a single dose of ABT-199

Secondary outcomes (1)

  1. Measurement of lymphocyte depletion and recovery

    explore pharmacokinetic/pharmacodynamic relationship

    Measured: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01686555
Sponsor's protocol ID
M13-093
Other IDs
2013-000328-33
Status last verified
Jul 2015
First submitted
13 Sep 2012
Last updated
20 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • Lu P, Fleischmann R, Curtis C, Ignatenko S, Clarke SH, Desai M, Wong SL, Grebe KM, Black K, Zeng J, Stolzenbach J, Medema JK. Safety and pharmacodynamics of venetoclax (ABT-199) in a randomized single and multiple ascending dose study in women with systemic lupus erythematosus. Lupus. 2018 Feb;27(2):290-302. doi: 10.1177/0961203317719334. Epub 2017 Jul 10.

    PubMed 28691866

  • Nader A, Minocha M, Othman AA. Exposure-Response Analyses of the Effects of Venetoclax, a Selective BCL-2 Inhibitor, on B-Lymphocyte and Total Lymphocyte Counts in Women with Systemic Lupus Erythematosus. Clin Pharmacokinet. 2020 Mar;59(3):335-347. doi: 10.1007/s40262-019-00818-5.

    PubMed 31541431

  • Minocha M, Zeng J, Medema JK, Othman AA. Pharmacokinetics of the B-Cell Lymphoma 2 (Bcl-2) Inhibitor Venetoclax in Female Subjects with Systemic Lupus Erythematosus. Clin Pharmacokinet. 2018 Sep;57(9):1185-1198. doi: 10.1007/s40262-017-0625-2.

    PubMed 29333561

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-199 in people with Lupus Erythematosus, run by AbbVie (prior sponsor, Abbott) at 15 sites in 4 countries.

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Mexico, Germany, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of participants with Adverse Events (time frame: From first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01686555, which also lists 3 linked publications.

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 20 Nov 2017.

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