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Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease

Primary Purpose

Celiac Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TIMP-GLIA
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring safety, tolerability, pharmacokinetics, celiac, gliadin, gluten

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject provides written informed consent and is willing and able to comply with study requirements.
  • At screening the subject has a minimum body mass index (BMI) of 16 kg/m2 and a minimum body weight of 33 kg up to a maximum body weight of 129 kg, inclusive. If subject is considered to be underweight or overweight/obese, the subject is otherwise healthy in the opinion of the investigator.
  • The subject has celiac disease characterized at Screening Visit by:
  • a history of biopsy-confirmed celiac disease; and
  • no known gluten exposure for at least 10 days; and
  • willingness to maintain a gluten-free diet for the duration of the study; and
  • a negative or weak positive transglutaminase (tTG)-specific IgA titer if the subject has a normal total immunoglobulin A (IgA) titer or has a partial IgA deficiency OR
  • a negative or weak positive deamidated gliadin peptide (DGP)-specific immunoglobulin G (IgG) titer if the subject has IgA deficiency.
  • The male subject or female subject of childbearing potential will practice medically approved contraception during the study.

Exclusion Criteria:

  • The subject has a history of clinically confirmed immunoglobulin E-mediated reaction and/or anaphylaxis to wheat (i.e., "wheat allergy"), barley or rye.
  • The subject has a known history of hypersensitivity or allergies to TIMP-GLIA components OR any other known severe hypersensitivity or allergic reaction (resulted in hospitalization [initial or prolonged], congenital anomaly, or disability, or that required medical intervention to prevent permanent impairment or damage) to any other allergens (medications, food or environmental).
  • The subject has uncontrolled celiac disease and/or complications of celiac disease, or otherwise has experienced celiac symptomology within 10 days of screening, in the opinion of the investigator.
  • The subject has a history of, or has an active, significant, clinically relevant, comorbidity (including Type 1 and Type 2 diabetes mellitus and other autoimmune disorders, splenectomy) that, in the opinion of the investigator, would make the subject unsuitable for participation in the study and/or could adversely affect interpretation of the study results.
  • The subject has had significant changes to or anticipates changes to prescription or non-prescription medication used to manage an underlying comorbidity within 30 days prior to first dosing (Day 1).
  • The subject is currently taking or received systemic biologics 6 months prior to first dosing (Day 1).
  • The subject has a compromised immune system, e.g.
  • known human immunodeficiency virus (HIV) infection or positive for HIV antibodies at Screening or
  • immunosuppressive medical treatment taken during the 2 months prior to first dosing (Day 1) or
  • immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily for 2 weeks or more within 2 months prior to first dosing (Day 1), or any dose of corticosteroids within 30 days of first dosing (Day 1), or high dose inhaled corticosteroids [>960 µg/day of beclomethasone dipropionate or equivalent]) within 30 days of first dosing Day 1.
  • The subject has currently untreated or active gastrointestinal disease such as peptic ulcer disease, esophagitis (Los Angeles Classification ≥ Grade C), irritable bowel syndrome, inflammatory bowel disease, or microscopic colitis.
  • The subject has an active malignancy, or history of malignancy or chemotherapy, within the past 5 years other than history of localized or surgical removal of focal basal cell skin cancer, cervical cancer in situ treated successfully in the past by local treatment (including but not limited to cryotherapy or laser therapy) or by hysterectomy.
  • The subject has known liver disease or serology positive for hepatitis C infection; positive hepatitis B surface antigen (HBsAg) at Screening Visit.
  • The subject has a positive test result for drugs of abuse, cannabinoids, or alcohol at Screening Visit or at Check-in.
  • The subject has a history of any drug or alcohol abuse in the past 5 years or alcohol consumption habits that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements.
  • The subject has clinically significant laboratory test results (e.g., liver tests) or electrocardiogram (EGC) abnormalities (e.g., cardiac conduction abnormalities) at Screening
  • The subject received a live or inactive vaccine within 28 days prior or a subunit vaccine within 14 days prior to first dosing/Day 1 or the subject has a planned vaccination during the study.

Sites / Locations

  • Jacksonville Center For Clinical Research
  • Mass General Hospital Translational and Clinical Research Centers
  • Mayo Gastroenterology Research Unit
  • Prism Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A, Cohort 1: 0.1 mg/kg

Part A, Cohort 2: 0.5 mg/kg

Part A, Cohort 3: 1.0 mg/kg

Part A, Cohort 4: 2.0 mg/kg

Part A, Cohort 5: 4.0 mg/kg

Part A, Cohort 6: 8.0 mg/kg

Part B, Cohort 1: 2.0 mg/kg

Part B, Cohort 2: 4.0 mg/kg

Part B, Cohort 3: 8.0 mg/kg

Arm Description

TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.

TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.

TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.

TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.

TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.

TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.

TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.

TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.

TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.

Outcomes

Primary Outcome Measures

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of Participants With Grade 3 or Higher TEAEs and Drug-related Adverse Events
AE Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.0. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. Drug-related adverse events are those that the investigator assessed as possibly or probably related to the study treatment.
Number of Participants With Clinically Significant Physical Examination Findings
Number of Participants With Clinically Significant Electrocardiograms (ECG) Findings
Number of Participants With Clinically Significant Change From Baseline in Arterial Oxygen Saturation Levels
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 3
Baseline is defined as Day 1 pre-dose.
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 7
Baseline is defined as Day 1 pre-dose.
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 8
Baseline is defined as Day 1 pre-dose.
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 10
Baseline is defined as Day 1 pre-dose.
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 14
Baseline is defined as Day 1 pre-dose.
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 38
Baseline is defined as Day 1 pre-dose.
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 60
Baseline is defined as Day 1 pre-dose.
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 15 Minutes Post-dose on Day 1
Baseline was defined as Day 1 Pre-dose.
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 30 Minutes Post-dose on Day 1
Baseline was defined as Day 1 Pre-dose.
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at Day 2
Baseline was defined as Day 1 Pre-dose.
Number of Participants With Clinically Significant Change From Baseline in Hematology, Serum Chemistry, Coagulation, and Urinalysis
Part A (Greater Than or Equal to [>=] 4.0 mg/kg) and Part B: Number of Participants With Clinically Significant Change From Baseline in Gliadin-Specific T-cell Proliferation and Cytokine Release Markers
Number of Participants With Clinically Significant Laboratory Abnormalities

Secondary Outcome Measures

Cmax: Maximum Observed Plasma Concentration For TIMP-GLIA
Clast: Last Measurable Observed Plasma Concentration For TIMP-GLIA
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TIMP-GLIA
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TIMP-GLIA
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TIMP-GLIA
Tlast: Time to Reach the Last Measurable Plasma Concentration for TIMP-GLIA
T1/2: Terminal Phase Elimination Half-life (T1/2) for TIMP-GLIA

Full Information

First Posted
March 21, 2018
Last Updated
May 20, 2020
Sponsor
Takeda
Collaborators
COUR Pharmaceutical Development Company, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03486990
Brief Title
Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease
Official Title
A Phase 1, First-in-Human, 2-Part, Multicenter Dose Escalation and Repeat Dose Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
May 24, 2019 (Actual)
Study Completion Date
July 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
Collaborators
COUR Pharmaceutical Development Company, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is to characterize the safety and tolerability of an investigational drug called TIMP-GLIA when either one or two intravenous doses are given to subjects with celiac disease. The way the body reacts to TIMP-GLIA is being checked by laboratory tests of the blood and urine, and study subject health will also be monitored by vital signs such as blood pressure, electrocardiogram (ECG), and physical examination.
Detailed Description
This study is a 2-part, multicenter study. In Part A, eligible subjects will be enrolled into escalating dose cohorts (n = 2/cohort for 2 dose levels followed by n = 3/cohort for 4 dose levels). TIMP-GLIA will be administered as a single intravenous (IV) infusion on Day 1. A staggered dosing strategy will be used in Part A. Subjects will undergo medical observation in the clinic for at least 48 hours after dosing and participate in outpatient follow-up visits. Adverse events (AEs), vital signs, and electrocardiograms (ECGs) and laboratory data (serum chemistry, coagulation, hematology and urinalysis, cytokines) will be assessed by a Safety Committee before the next cohort will be dosed at a higher dose level. After completion of Part A and confirmation by the Safety Committee to proceed, eligible subjects (n=3) will receive two IV infusions of TIMP-GLIA, 7 days apart, on Day 1 and on Day 8. Each subject in Part B will be observed in clinic for 48 hours after each dose and undergo similar testing and follow-up visits as in Part A. The safety and pharmacokinetic profile of TIMP-GLIA will be characterized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
safety, tolerability, pharmacokinetics, celiac, gliadin, gluten

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Single ascending dose followed by repeat dose.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A, Cohort 1: 0.1 mg/kg
Arm Type
Experimental
Arm Description
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
Arm Title
Part A, Cohort 2: 0.5 mg/kg
Arm Type
Experimental
Arm Description
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
Arm Title
Part A, Cohort 3: 1.0 mg/kg
Arm Type
Experimental
Arm Description
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
Arm Title
Part A, Cohort 4: 2.0 mg/kg
Arm Type
Experimental
Arm Description
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
Arm Title
Part A, Cohort 5: 4.0 mg/kg
Arm Type
Experimental
Arm Description
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
Arm Title
Part A, Cohort 6: 8.0 mg/kg
Arm Type
Experimental
Arm Description
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
Arm Title
Part B, Cohort 1: 2.0 mg/kg
Arm Type
Experimental
Arm Description
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Arm Title
Part B, Cohort 2: 4.0 mg/kg
Arm Type
Experimental
Arm Description
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Arm Title
Part B, Cohort 3: 8.0 mg/kg
Arm Type
Experimental
Arm Description
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Intervention Type
Drug
Intervention Name(s)
TIMP-GLIA
Other Intervention Name(s)
TAK-101
Intervention Description
intravenous infusion.
Primary Outcome Measure Information:
Title
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame
From Day 1 up to Day 180
Title
Number of Participants With Grade 3 or Higher TEAEs and Drug-related Adverse Events
Description
AE Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.0. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. Drug-related adverse events are those that the investigator assessed as possibly or probably related to the study treatment.
Time Frame
From Day 1 up to Day 180
Title
Number of Participants With Clinically Significant Physical Examination Findings
Time Frame
From Day 1 up to Day 60
Title
Number of Participants With Clinically Significant Electrocardiograms (ECG) Findings
Time Frame
From Day 1 up to Day 60
Title
Number of Participants With Clinically Significant Change From Baseline in Arterial Oxygen Saturation Levels
Time Frame
From Day 1 up to Day 60
Title
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
Time Frame
From Day 1 up to Day 60
Title
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 3
Description
Baseline is defined as Day 1 pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and Day 3
Title
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 7
Description
Baseline is defined as Day 1 pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and Day 7
Title
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 8
Description
Baseline is defined as Day 1 pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and Day 8
Title
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 10
Description
Baseline is defined as Day 1 pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and Day 10
Title
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 14
Description
Baseline is defined as Day 1 pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and Day 14
Title
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 38
Description
Baseline is defined as Day 1 pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and Day 38
Title
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 60
Description
Baseline is defined as Day 1 pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and Day 60
Title
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 15 Minutes Post-dose on Day 1
Description
Baseline was defined as Day 1 Pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and 15 minutes (min) post-dose on Day 1
Title
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 30 Minutes Post-dose on Day 1
Description
Baseline was defined as Day 1 Pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and 30 min post-dose on Day 1
Title
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at Day 2
Description
Baseline was defined as Day 1 Pre-dose.
Time Frame
Baseline (Day 1 pre-dose) and Day 2
Title
Number of Participants With Clinically Significant Change From Baseline in Hematology, Serum Chemistry, Coagulation, and Urinalysis
Time Frame
From Day 1 up to Day 60
Title
Part A (Greater Than or Equal to [>=] 4.0 mg/kg) and Part B: Number of Participants With Clinically Significant Change From Baseline in Gliadin-Specific T-cell Proliferation and Cytokine Release Markers
Time Frame
Part A (>=4.0 mg/kg): Day 1 pre-dose up to 144 hours post-dose on Day 7; Part B: Day 8 pre-dose up to 144 hours post-dose on Day 14
Title
Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame
From Day 1 up to Day 60
Secondary Outcome Measure Information:
Title
Cmax: Maximum Observed Plasma Concentration For TIMP-GLIA
Time Frame
Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Title
Clast: Last Measurable Observed Plasma Concentration For TIMP-GLIA
Time Frame
Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Title
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TIMP-GLIA
Time Frame
Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Title
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TIMP-GLIA
Time Frame
Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Title
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TIMP-GLIA
Time Frame
Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Title
Tlast: Time to Reach the Last Measurable Plasma Concentration for TIMP-GLIA
Time Frame
Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Title
T1/2: Terminal Phase Elimination Half-life (T1/2) for TIMP-GLIA
Time Frame
Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject provides written informed consent and is willing and able to comply with study requirements. At screening the subject has a minimum body mass index (BMI) of 16 kg/m2 and a minimum body weight of 33 kg up to a maximum body weight of 129 kg, inclusive. If subject is considered to be underweight or overweight/obese, the subject is otherwise healthy in the opinion of the investigator. The subject has celiac disease characterized at Screening Visit by: a history of biopsy-confirmed celiac disease; and no known gluten exposure for at least 10 days; and willingness to maintain a gluten-free diet for the duration of the study; and a negative or weak positive transglutaminase (tTG)-specific IgA titer if the subject has a normal total immunoglobulin A (IgA) titer or has a partial IgA deficiency OR a negative or weak positive deamidated gliadin peptide (DGP)-specific immunoglobulin G (IgG) titer if the subject has IgA deficiency. The male subject or female subject of childbearing potential will practice medically approved contraception during the study. Exclusion Criteria: The subject has a history of clinically confirmed immunoglobulin E-mediated reaction and/or anaphylaxis to wheat (i.e., "wheat allergy"), barley or rye. The subject has a known history of hypersensitivity or allergies to TIMP-GLIA components OR any other known severe hypersensitivity or allergic reaction (resulted in hospitalization [initial or prolonged], congenital anomaly, or disability, or that required medical intervention to prevent permanent impairment or damage) to any other allergens (medications, food or environmental). The subject has uncontrolled celiac disease and/or complications of celiac disease, or otherwise has experienced celiac symptomology within 10 days of screening, in the opinion of the investigator. The subject has a history of, or has an active, significant, clinically relevant, comorbidity (including Type 1 and Type 2 diabetes mellitus and other autoimmune disorders, splenectomy) that, in the opinion of the investigator, would make the subject unsuitable for participation in the study and/or could adversely affect interpretation of the study results. The subject has had significant changes to or anticipates changes to prescription or non-prescription medication used to manage an underlying comorbidity within 30 days prior to first dosing (Day 1). The subject is currently taking or received systemic biologics 6 months prior to first dosing (Day 1). The subject has a compromised immune system, e.g. known human immunodeficiency virus (HIV) infection or positive for HIV antibodies at Screening or immunosuppressive medical treatment taken during the 2 months prior to first dosing (Day 1) or immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily for 2 weeks or more within 2 months prior to first dosing (Day 1), or any dose of corticosteroids within 30 days of first dosing (Day 1), or high dose inhaled corticosteroids [>960 µg/day of beclomethasone dipropionate or equivalent]) within 30 days of first dosing Day 1. The subject has currently untreated or active gastrointestinal disease such as peptic ulcer disease, esophagitis (Los Angeles Classification ≥ Grade C), irritable bowel syndrome, inflammatory bowel disease, or microscopic colitis. The subject has an active malignancy, or history of malignancy or chemotherapy, within the past 5 years other than history of localized or surgical removal of focal basal cell skin cancer, cervical cancer in situ treated successfully in the past by local treatment (including but not limited to cryotherapy or laser therapy) or by hysterectomy. The subject has known liver disease or serology positive for hepatitis C infection; positive hepatitis B surface antigen (HBsAg) at Screening Visit. The subject has a positive test result for drugs of abuse, cannabinoids, or alcohol at Screening Visit or at Check-in. The subject has a history of any drug or alcohol abuse in the past 5 years or alcohol consumption habits that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements. The subject has clinically significant laboratory test results (e.g., liver tests) or electrocardiogram (EGC) abnormalities (e.g., cardiac conduction abnormalities) at Screening The subject received a live or inactive vaccine within 28 days prior or a subunit vaccine within 14 days prior to first dosing/Day 1 or the subject has a planned vaccination during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Jacksonville Center For Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Mass General Hospital Translational and Clinical Research Centers
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Gastroenterology Research Unit
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Prism Clinical Research
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Citations:
PubMed Identifier
33722583
Citation
Kelly CP, Murray JA, Leffler DA, Getts DR, Bledsoe AC, Smithson G, First MR, Morris A, Boyne M, Elhofy A, Wu TT, Podojil JR, Miller SD; TAK-101 Study Group. TAK-101 Nanoparticles Induce Gluten-Specific Tolerance in Celiac Disease: A Randomized, Double-Blind, Placebo-Controlled Study. Gastroenterology. 2021 Jul;161(1):66-80.e8. doi: 10.1053/j.gastro.2021.03.014. Epub 2021 Mar 17.
Results Reference
derived

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Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease

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