Autologous Polyclonal Tregs for Lupus

October 22, 2019 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I, Open-Label, Dose Escalation Trial Exploring the Safety and Tolerability of Autologous Polyclonal Regulatory T Cell Therapy in Adults With Active Cutaneous Lupus (ALE08)

The primary purpose of this Phase 1 study is to evaluate the safety, tolerability, and effect of 3 different doses of Treg therapy in adults with skin (cutaneous) involvement of their lupus. Targeting cutaneous disease offers the ability to control background therapy, readily detect clinical effects, and perform research analyses not only in blood but also skin. Safety, disease activity, and mechanism of Tregs will be evaluated. The intent is to support dose selection for a future larger efficacy trial in lupus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigational therapy in this trial, regulatory T cells (Tregs), is evaluating an alternative to traditional immunosuppressive therapies for the treatment of systemic lupus erythematosus (SLE, lupus). Too frequently, aggressive therapies are inadequate in the control of the disease and have potent side effects and complications. The collection and expansion of one's own T cells harnesses a naturally occurring regulatory mechanism to restore self-tolerance in people with lupus. Tregs are a specialized subset of T cells that function to control the immune response. Studies have shown that in active lupus, the numbers and function of Treg cells are significantly decreased, which contributes to an overactive immune system and an increase in disease activity. The hope is that these naturally occurring Treg cells can be used for the treatment of autoimmune diseases, including lupus.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to provide informed consent.
  • Diagnosis of SLE by American College of Rheumatology (ACR) criteria or biopsy proven primary cutaneous lupus.
  • Presence of ≥ 2 active cutaneous lupus lesions based on (1) visual morphology and (2) at least a grade 2 erythema on CLASI activity score. Histopathologic confirmation is required unless the active lesions are of the same morphology to previously histologically proven cutaneous lupus lesions.

  • The cutaneous lupus lesions must include any of the following subtypes:

    • Acute cutaneous lupus including maculopapular lupus rash and photosensitive lupus rash,
    • Subacute cutaneous lupus,
    • Chronic cutaneous lupus including discoid lupus and hypertrophic (verrucous) lupus,
    • Lupus timidus
  • Positive test for Epstein-Barr virus (EBV) antibody.
  • Adequate venous access to support draw of 400 mL whole blood and infusion of investigational therapy.

Exclusion Criteria:

  • New onset of cutaneous lupus which has not been treated with broad spectrum sunscreen (UVA and UVB) in combination with either antimalarials or another systemic medication for at least 3 months.
  • Prednisone dose > 15mg/day within the 30 days prior to screening.

  • Addition of a new medication, or change in the dose of any background medication, used to treat any aspect of SLE. Specifically:

    • addition or change in systemic glucocorticoids, antimalarials, methotrexate, mycophenolate mofetil, mycophenolic acid, azathioprine, cyclosporine, tacrolimus, thalidomide, lenalidomide, dapsone, acitretin, or isotretinoin within 90 days prior to screening
    • treatment with cyclophosphamide within 90 days prior to screening.

  • Doses of background medications at Screening visit:

    • hydroxychloroquine > 400 mg/day,
    • chloroquine > 250 mg/day,
    • quinacrine >100 mg/day,
    • methotrexate > 25 mg/week,
    • mycophenolate mofetil (MMF)> 3000 mg/day,
    • mycophenolic acid > 720 mg/day BID,
    • azathioprine > 200 mg/day,
    • cyclosporine > 5 mg/day divided BID,
    • tacrolimus > 6 mg/day
    • thalidomide > 300 mg/day,
    • lenalidomide > 10 mg/day,
    • dapsone > 250 mg/day,
    • acitretin > 50 mg/d (or > 1 mg/kg/day),
    • isotretinoin > 120 mg/d (or > 2 mg/kg/day).
  • Intravenous immunoglobulin (IVIG), plasmapheresis, or leukopheresis within the 90 days prior to screening.
  • Use of rituximab within the 12 months prior to screening.
  • Change in dosing frequency, concentration, or applied surface area of topical steroids, tacrolimus, and/or pimecrolimus within 4 weeks prior to screening.
  • Active severe central nervous system lupus.
  • SELENA-SLEDAI's seizure, psychosis, organic brain syndrome, visual disturbance,cranial nerve disorder, lupus headache, cerebrovascular accident (CVA), vasculitis,arthritis, myositis, mucosal ulcers, pleurisy, pericarditis, and fever scores > 8 total.
  • Active lupus nephritis (spot protein / creatinine ratio > 1.0 mg/mg).
  • End stage renal disease (estimated glomerular filtration rate [eGFR] < 20 ml/min/1.73m^2 using the CKD-EPI equation [53]).
  • Drug induced lupus.
  • Hemoglobin < 10 g/dL.
  • White blood cell (WBC) count < 2,500/ mm^3 (equivalent to < 2.5 x10^9/L).
  • Lymphocyte count < 625/mm^3 (equivalent to < 0.625 x10^9/L).
  • Absolute neutrophil count < 1,500/mm3 (equivalent to < 1.5 x10^9/L).
  • Platelets < 75,000/mm^3 (equivalent to < 75 x 10^9/L).
  • Liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], or alkaline phosphatase [ALK]) results that are ≥ 2 times the upper limit of normal (ULN).
  • Direct bilirubin > ULN.
  • Active bacterial, viral, fungal, or opportunistic infections requiring systemic antiinfective therapy.
  • Presence of positive purified protein derivative tuberculin skin test (PPD, > 5mm induration [regardless of Bacille Calmette Guerin (BCG) vaccine administration]) or positive or indeterminate QuantiFERON(R)-TB Gold In-Tube Test (QFT-G_IT) at screening.
  • Evidence of infection with human immunodeficiency virus (HIV), hepatitis B (as assessed by HBsAg and anti-HBc) or hepatitis C.
  • Detectable circulating EBV or cytomegalovirus (CMV) genomes or active infection.
  • Chronic infection that is currently being treated with suppressive anti-infective therapy, including but not limited to tuberculosis, pneumocystis, CMV, herpes zoster, and atypical mycobacteria.
  • Herpes simplex virus infection requiring chronic, suppressive therapy with an anti-viral medication.
  • Receipt of a live-attenuated vaccine within 12 months prior to screening.
  • Concomitant malignancies or a history of malignancy, with the exception of adequately treated basal and squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
  • Pregnancy.
  • Breastfeeding.
  • Unwilling or unable to use reliable method(s) of contraception from four weeks prior to Day 0 throughout three months after Treg dosing (males) or for two years after Treg dosing (females). Note: investigators of female participants of childbearing potential on concurrent MMF, and those participants themselves, whether or not they plan to become pregnant, are strongly encouraged to participate in Mycophenolate Risk Evaluation and Mitigation Strategy (REMS).
  • Use of an experimental therapeutic agent within the calendar year prior to screening.
  • Use of biologic medications other than rituximab within the 90 days or 5 half-lives,whichever is greater, prior to screening.

  • Concomitant medical condition that places the subject at risk by participating in this study, including but not limited to:

    • another severe, systemic autoimmune disease or condition (besides lupus) requiring systemic immunosuppressive therapy (e.g., rheumatoid arthritis, systemic sclerosis, primary Sjogren's syndrome, primary vasculitis, psoriasis, multiple sclerosis, ankylosing spondylitis, and inflammatory bowel disease), or
    • severe, progressive, or poorly controlled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease, either related or unrelated to SLE, or
    • history of significant infection or recurrent infection that, in the investigator's opinion, places the subject at risk by participating in this study
    • any other concomitant medical condition that, in the investigator's opinion, places the subject at risk by participating in this study.
  • Comorbidities requiring glucocorticoid therapy, including those which have required three or more courses of systemic glucocorticoids within the previous 12 months.
  • Current or history within the past year of substance abuse.
  • Inability to comply with study and follow-up procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low Dose Treg Cohort
3-6 participants will receive a single infusion of 1 x 10^ 8 autologous polyclonal Tregs (ex vivo selected and expanded)
Biological: Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells
Other Names:
  • Ex vivo Expanded Autologous CD4+CD127lo/-CD25+ Polyclonal Regulatory T Cells
Experimental: Medium Dose Treg Cohort
Sequential dose escalation, 3-6 subjects will receive a single infusion of 4 x 10^ 8 autologous polyclonal Tregs (ex vivo selected and expanded)
Biological: Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells
Other Names:
  • Ex vivo Expanded Autologous CD4+CD127lo/-CD25+ Polyclonal Regulatory T Cells
Experimental: High Dose Treg Cohort
Sequential dose escalation, 3-6 participants will receive a single infusion of 16 x 10^ 8 autologous polyclonal Tregs (ex vivo selected and expanded)
Biological: Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells
Other Names:
  • Ex vivo Expanded Autologous CD4+CD127lo/-CD25+ Polyclonal Regulatory T Cells

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Significant Adverse Events (AEs) Through Week 48
Time Frame: From time of signed informed consent to Week 48
A significant adverse event is any related National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0 Grade 3 or higher AE or any related serious adverse event. Related is defined as being possibly, probably, or definitely related to the ex vivo expanded autologous PolyTregs, as determined by the safety review committee.
From time of signed informed consent to Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Significant Adverse Events (AEs) Through Week 152
Time Frame: From time of signed informed consent to Week 152
A significant adverse event is any related National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0 Grade 3 or higher AE or any related serious adverse event. Related is defined as being possibly, probably, or definitely related to the ex vivo expanded autologous PolyTregs, as determined by the safety review committee.
From time of signed informed consent to Week 152
Number of Grade 3 or Higher Adverse Events (AEs) Through Week 152
Time Frame: From time of signed informed consent to Week 152
Adverse events (AEs) Grade 3 or higher were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0.
From time of signed informed consent to Week 152
Number of Infection-Related Adverse Events (AEs) Through Week 152
Time Frame: From time of signed informed consent to Week 152
If the adverse event was believed to be caused by a viral, bacterial, or fungal organism, regardless of whether it was treated with antibiotics or not, then it was classified as infection-related.
From time of signed informed consent to Week 152
Number of Lupus Flares Through Week 152 by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Criteria
Time Frame: From time of signed informed consent to Week 152
An activity score increase of ≥4 CLASI points defines a flare. A mild/moderate flare includes at least one of the following SELENA-SLEDAI criteria: Increase in the SLEDAI Score of ≥3 points, new or worse discoid, photosensitive, profundus, cutaneous vasculitis, bullous lupus, nasopharyngeal ulcers, pleuritic, pericarditis, arthritis, fever attributable to SLE; increase in prednisone (<0.5 mg/kg/day); added NSAID or Plaquenil; increase in PhGA (<2.5 [on a 3.0 indexed VAS scale]). A severe flare includes at least one of the following SELENA-SLEDAI criteria: Increase of >12 in the SLEDAI Score; new or worse CNS-SLE, vasculitis, nephritis, myositis, platelet count <60,000/mm^3, hemolytic anemia with hemoglobin <7% or decrease in hemoglobin >3%; prednisone >0.5 mg/kg/day; new Cyclophosphamide, Azathioprine, Methotrexate, Mycophenolate Mofetil, or hospitalization attributable to SLE; increase in PhGA to >2.5.
From time of signed informed consent to Week 152
Number Infusion-Related Adverse Events (AEs) Within 24 Hours of Infusion
Time Frame: From time of infusion to 24 hours post infusion
Any infusion-related adverse events Grade 1 or higher within 24 hours of polyclonal Treg infusion. This study graded the severity of adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0.
From time of infusion to 24 hours post infusion
Change From Baseline: Alkaline Phosphatase (ALK), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)
Time Frame: Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values are based on subject age, gender, and the specific laboratory methods that were used to determine the lab values.
Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change From Baseline in g/dL: Albumin, Hemoglobin
Time Frame: Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.
Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change From Baseline in mg/dL: Total Bilirubin, Creatinine
Time Frame: Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.
Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change From Baseline in mmol/L: Potassium, Sodium, Chloride
Time Frame: Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.
Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change From Baseline in Cell Counts: White Blood Cells (WBC), Total Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets
Time Frame: Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.
Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change From Baseline Red Blood Cell Count
Time Frame: Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.
Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change From Baseline in mm/hr: Sedimentation Rate (ESR)
Time Frame: Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.
Baseline (Visit 0) and Weeks 4, 12, 48, and 152
Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score
Time Frame: Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated, physician-based assessment tool used to measure cutaneous lupus severity. Severity is calculated based on disease activity (erythema and scale) and damage (dyspigmentation and scarring) for the cumulative areas of involved skin. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70). A 4-point or 20% change in the CLASI activity score identifies a clinically meaningful change. A 4-point increase in the CLASI activity score indicates a flare.
Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
Change From Baseline in SELENA-SLEDAI Total Score
Time Frame: Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
The Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score is a weighted scale score ranging from 0 to 105 based on the presence or absence of 24 manifestations of SLE. The SELENA-SLEDAI assesses disease activity for 10 days prior to and including the day of assessment. Positive change in the SELENA-SLEDAI score indicates increased disease activity.
Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
Change From Baseline in Patient's Global Assessment (PGA)
Time Frame: Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
The global assessment (PGA) is a visual 3-inch analog scale from 0 to 3 in which the participant marks the scale according to perceived disease activity. A score of 0 corresponds to no lupus disease activity and a score of 3 corresponds to severe disease activity. A positive change from baseline indicates more disease activity.
Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
Change From Baseline in Physician's Global Assessment (PhGA)
Time Frame: Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
The physician's global assessment (PhGA) is a visual analog 3-inch scale in the SELENA-SLEDAI that is scored from 0 to 3 by the physician. A score of 0 corresponds to no lupus disease activity and a score of 3 corresponds to severe disease activity. A positive change from baseline indicates more disease activity.
Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
Change From Baseline in Anti-dsDNA Antibody Titers
Time Frame: Baseline ( Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
Double-stranded DNA is one of multiple diagnostic tests for SLE and high levels may be associated with disease activity. The positive range is based on the normal range from the local laboratory. A positive change from baseline value indicates the detection of autoantibodies to double-stranded DNA.
Baseline ( Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
Change From Baseline in Serum C3 Complement Levels
Time Frame: Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 71 to 159 mg/dL. Those with active systemic lupus erythematosus (SLE) may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate SLE disease activity.
Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
Change From Baseline in Serum C4 Complement Levels
Time Frame: Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152
C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range is 13 to 30 mg/dL. Individuals with active systemic lupus erythematosus (SLE) may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity.
Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Autoimmunity Centers of Excellence

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Maria Dall'Era, MD, University of California, San Francisco
  • Study Chair: Anna Haemel, MD, University of California, San Francisco
  • Study Chair: Jeffrey Bluestone, PhD, University of California, San Francisco
  • Study Chair: Michael Rosenblum, MD, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 3, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DAIT ALE08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The plan is to share participant level data and additional relevant materials in the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts. Currently: study in progress-no data sharing.

IPD Sharing Time Frame

The aim is to share data available to the public within 24 months upon completion of the study.

IPD Sharing Access Criteria

Will be available to the public.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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