Celiac Disease
Conditions
Brief summary
Subjects enrolled in this study will be evaluated for immune responses and histological changes in the small bowel following 2 doses of TIMP-GLIA or placebo and a 14-day oral gluten challenge.
Detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial to assess the safety, pharmacodynamics, efficacy, and PK, of TIMP-GLIA in subjects with well-controlled celiac disease (CD) following an oral gluten challenge. Subjects aged 18 to 70 years inclusive, with documented history of biopsy-proven confirmed CD, and on a gluten-free diet (GFD) for a minimum of 6 months, will be screened. Subjects who meet all inclusion and no exclusion criteria, and provide written informed consent, will be randomized within 45 days after Screening to receive 2 intravenous (IV) infusions of TIMP-GLIA, 8 mg/kg up to a maximum of 650 mg or placebo (normal saline) in a 1:1 ratio. Treatment with drug or placebo will be followed by 14 days gluten challenge.
Interventions
DRUGTIMP-GLIA
8 mg/kg up to a maximum of 650 mg administered intravenously on days 1 and 8.
DRUGPlacebo
Administered intravenously on days 1 and 8.
Sponsors
COUR Pharmaceutical Development Company, Inc.
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized double-blind placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or nonpregnant female, ages 18 to 70 years inclusive, at Screening Visit. 2. Biopsy-confirmed CD (intestinal histology showing villous atrophy). 3. Positive for human leukocyte antigen (HLA)-DQ2 or HLA-DQ2/DQ8 - results will be obtained at Screening if unknown or results are not available. 4. Self-reported to be on a GFD for at least 6 months prior to Screening and agree to continue GFD throughout study, with the exception of the oral gluten challenge. Normal or negative celiac serology, at screening, defined as: 1. Measurable total serum immunoglobulin A (IgA) AND 2. Negative or weak positive tissue transglutaminase (tTG) IgA titer OR 3. If IgA deficient, defined by a serum IgA level of \< 3 mg/dL, negative or weak positive DGP- IgG titer. 6\. Vh:Cd ≥ 1.5 on screening biopsy. Key
Exclusion criteria
1. Positive for only HLA-DQ8. 2. History of clinically confirmed immunoglobulin E (IgE)-mediated reaction and/or anaphylaxis to wheat (i.e., wheat allergy), barley or rye. 3. Uncontrolled CD and/or active signs/symptoms of CD, in the opinion of the investigator. 4. 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. 5. Immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior Dose 1, any dose of corticosteroids within 30 days of Day 1, or high dose inhaled corticosteroids \[\> 960 µg/day of beclomethasone dipropionate or equivalent\]) or other immunosuppressive agents. 6. Presence or history of celiac-associated thyroid disease or Type 1 diabetes, regardless of current treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Interferon-Gamma Spot Forming Units (IFN-gamma SFUs) in a Gliadin-specific Enzyme-linked Immunospot (ELISpot) at Day 20 | Baseline (Day 15/Day 1), Day 20 | The spots formed by interferon-gamma-secreting T-cells were counted with an automated ELISPOT analyzer. The average spot-forming units (SFU) per antigen was calculated. A response was considered positive when the average SFU in wells with a given peptide was at least twice that of the average SFU in the no-peptide control wells. Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15). Peripheral blood mononuclear cell is PBMC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1), Day 20 | Gliadin-specific T Cell cytokine secretion was determined by ELISA test. Gliadin-specific cytokine included interferon gamma (IFN-γ), interleukin (IL) 1-beta (1-β), IL-10, IL-12, IL-13, IL-2, IL-4, IL-6, IL-8, tumor necrosis factor alpha (TNF-α). Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15). A negative change from baseline value was reported when the observed sample response was less than the observed background response. |
| Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Baseline (Day 15/Day 1), Day 20 | Change from baseline value for Gut-Homing cells like CD4, CD8 and Gamma Delta T-cells were reported. Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15). Phenotype (unique cell population) for CD8 cell is EM CD8 \> aE+b7hi \> aE+b7hiCD38+, for CD4 is EM Th \> a4+b7hi \> a4+b7hiCD38+ and for Gamma Delta T-cells is TCRgd T cells \> aE+b7hi \> aE+b7hiCD38+ in this outcome measure. |
| Change From Baseline in Ratio of Villus Height to Crypt Depth (Vh:Cd) at Day 29 | Baseline (Screening), Day 29 | Attenuation of the effects of gluten exposure was assessed by measuring the change from baseline in villous height (Vh) to crypt depth (Cd) ratio after 29 days of gluten challenge. Villi were the small finger like projections that line the small intestine and promote nutrient absorption and are often shortened in participants with CD. Crypts are grooves between the villi that are often elongated in participants with CD. A decreased Vh:Cd ratio indicates worsening disease. Baseline was defined as the last sample collected prior to the first dose of study medication (Screening Period) on Day 1. |
| Percentage of Participants With Greater Than or Equal to (>=) 0.4 Decrease in Vh:Cd at Day 29 | Day 29 | Villi were the small finger like projections that line the small intestine and promote nutrient absorption and are often shortened in participants with CD. Crypts are grooves between the villi that are often elongated in participants with CD. A decreased Vh:Cd ratio indicates worsening disease. |
| Change From Baseline in Number of Intestinal Intraepithelial Lymphocytes (IELs) at Day 29 | Baseline (Screening), Day 29 | IELs were white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. Increased intraepithelial lymphocytes was associated with celiac disease. Baseline was defined as the last sample collected prior to the first dose of study medication (Screening Period) on Day 1. |
| Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | Days 15, 20, 29 and 35 | The CSI were clinically oriented, easily administered, questionnaires with 16 items. The modified CSI (6-items) was derived from a subset of questions from the CSI questionnaire, including the diarrhea, nausea, rumbling in stomach, stomach felt bloated, diarrhea and low energy level abdominal pain domains (a total of 6 questions), which were each assessed on a scale of 1 to 5- none of the time, a little of the time, some of the time, most of the time and all of the time respectively. Higher CSI scores correlate with more severe CD symptoms. It is to be used to assess symptoms before, during, and after the oral gluten challenge. Here D refers to Day. |
| Plasma Concentrations of TIMP-GLIA | Day 8: 0 hours (pre-infusion), end of infusion, and at 2 hours post-infusion | — |
| Change From Baseline in Gliadin-specific T Cell Proliferation by Enzyme-linked Immunosorbent Assay (ELISA) at Day 20 | Baseline (Day 15/Day 1), Day 20 | Gliadin-specific T cell proliferation was determined by ELISA test. Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15). |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | From the first dose of study drug up to Day 35 | — |
| Number of Participants With Clinically Significant Change From Baseline in Hematology or Serum Chemistry Laboratory Values | From the first dose of study drug up to Day 35 | — |
| Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Baseline (Screening), Days 8, 15, 20, 29, and 35 | Baseline was defined as the last sample collected prior to the first dose of study medication (Screening Period) on Day 1. |
| Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Baseline (Day 1), Days 2, 8, 9, and 15 | Baseline was defined as the pre-dose value on Day 1. |
| Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15 | Baseline (Day 1) , Days 2, 8, 9, and 15 | Baseline was defined as the pre-dose value on Day 1. |
| Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35 | Baseline (Day 1), Days 15, 20, 29, and 35 | Baseline was defined as the pre-dose value on Day 1. |
| Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1), Days 2, 8, 9, and 15 | Baseline was defined as Day 1 pre-dose. A negative change from baseline value was reported when the observed sample response was less than the observed background response. |
| Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | From the first dose of study drug up to Day 35 | — |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 6 investigative sites in the United States from 11 November 2018 to 22 July 2019.
Pre-assignment details
Participants diagnosed with celiac disease (CD) were enrolled in a 1:1 ratio in one of two treatment groups: Tolerogenic Immune Modifying Particles - Gliadin (TIMP-GLIA) or Placebo.
Participants by arm
| Arm | Count |
|---|---|
| TIMP-GLIA 8 mg/kg TIMP-GLIA 8 mg/kg, infusion, intravenously, once on Days 1 and 8. | 16 |
| Placebo TIMP-GLIA placebo-matching infusion, intravenously, once on Days 1 and 8. | 18 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participant Non-Compliance | 1 | 0 |
Baseline characteristics
| Characteristic | TIMP-GLIA 8 mg/kg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 44.6 years STANDARD_DEVIATION 13.47 | 42.2 years STANDARD_DEVIATION 16.71 | 43.3 years STANDARD_DEVIATION 15.09 |
| Body Mass Index (BMI) | 28.213 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.8479 | 27.100 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.8214 | 27.624 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.7933 |
| Disease Duration | 9.30 years | 8.45 years | 8.95 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 18 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gluten Free Diet Duration | 111.10 months | 113.45 months | 111.10 months |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 18 Participants | 34 Participants |
| Region of Enrollment United States | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Female | 13 Participants | 15 Participants | 28 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 18 |
| other Total, other adverse events | 16 / 16 | 18 / 18 |
| serious Total, serious adverse events | 0 / 16 | 0 / 18 |
Outcome results
Primary
Change From Baseline in Interferon-Gamma Spot Forming Units (IFN-gamma SFUs) in a Gliadin-specific Enzyme-linked Immunospot (ELISpot) at Day 20
The spots formed by interferon-gamma-secreting T-cells were counted with an automated ELISPOT analyzer. The average spot-forming units (SFU) per antigen was calculated. A response was considered positive when the average SFU in wells with a given peptide was at least twice that of the average SFU in the no-peptide control wells. Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15). Peripheral blood mononuclear cell is PBMC.
Time frame: Baseline (Day 15/Day 1), Day 20
Population: The pharmacodynamic population included all randomized participants who received two doses of study medication, completed at least the first 3 days of the gluten challenge (12 grams per day \[g/day\] for 3 days), and had pharmacodynamic results on Study Days 1, 15, and 20.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Change From Baseline in Interferon-Gamma Spot Forming Units (IFN-gamma SFUs) in a Gliadin-specific Enzyme-linked Immunospot (ELISpot) at Day 20 | Baseline (Day 15/Day 1) | 3.08 SFUs/10^6 cells PBMC | Standard Deviation 5.263 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Interferon-Gamma Spot Forming Units (IFN-gamma SFUs) in a Gliadin-specific Enzyme-linked Immunospot (ELISpot) at Day 20 | Change at Day 20 | 2.01 SFUs/10^6 cells PBMC | Standard Deviation 6.958 |
| Placebo | Change From Baseline in Interferon-Gamma Spot Forming Units (IFN-gamma SFUs) in a Gliadin-specific Enzyme-linked Immunospot (ELISpot) at Day 20 | Baseline (Day 15/Day 1) | 1.98 SFUs/10^6 cells PBMC | Standard Deviation 3.184 |
| Placebo | Change From Baseline in Interferon-Gamma Spot Forming Units (IFN-gamma SFUs) in a Gliadin-specific Enzyme-linked Immunospot (ELISpot) at Day 20 | Change at Day 20 | 17.57 SFUs/10^6 cells PBMC | Standard Deviation 25.283 |
p-value: 0.0056Wilcoxon Rank Sum test
Secondary
Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35
Baseline was defined as the last sample collected prior to the first dose of study medication (Screening Period) on Day 1.
Time frame: Baseline (Screening), Days 8, 15, 20, 29, and 35
Population: The safety population included all randomized participants who received at least one dose of study medication. Participants evaluable for this measure at given time point were included for the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Baseline (Screening) | 7.9 units | Standard Deviation 11.53 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Change at Day 8 | 4.3 units | Standard Deviation 7.43 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Change at Day 15 | 27.8 units | Standard Deviation 28.92 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Change at Day 20 | 28.6 units | Standard Deviation 29.63 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Change at Day 29 | 28.4 units | Standard Deviation 31.27 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Change at Day 35 | 28.4 units | Standard Deviation 29.68 |
| Placebo | Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Change at Day 29 | 8.9 units | Standard Deviation 13.23 |
| Placebo | Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Baseline (Screening) | 5.9 units | Standard Deviation 3.48 |
| Placebo | Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Change at Day 20 | -0.1 units | Standard Deviation 1.76 |
| Placebo | Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Change at Day 8 | -0.6 units | Standard Deviation 1.58 |
| Placebo | Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Change at Day 35 | 20.7 units | Standard Deviation 27.04 |
| Placebo | Change From Baseline in Deamidated Gliadin Peptide Immunoglobulin G (DGP-IgG) Antibodies at Days 8, 15, 20, 29, and 35 | Change at Day 15 | 0.3 units | Standard Deviation 1.67 |
Secondary
Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20
Gliadin-specific T Cell cytokine secretion was determined by ELISA test. Gliadin-specific cytokine included interferon gamma (IFN-γ), interleukin (IL) 1-beta (1-β), IL-10, IL-12, IL-13, IL-2, IL-4, IL-6, IL-8, tumor necrosis factor alpha (TNF-α). Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15). A negative change from baseline value was reported when the observed sample response was less than the observed background response.
Time frame: Baseline (Day 15/Day 1), Day 20
Population: The pharmacodynamic population included all randomized participants who received two doses of study medication, completed at least the first 3 days of the gluten challenge (12 g/day for 3 days), and had pharmacodynamic results on Study Days 1, 15, and 20. Participants evaluable for this measure at given time point were included for the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IFN-γ | 1.44 pg/mL | Standard Deviation 2.727 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IFN-γ | -0.43 pg/mL | Standard Deviation 2.044 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL1-β | 1.24 pg/mL | Standard Deviation 1.507 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL1-β | 0.00 pg/mL | Standard Deviation 1.456 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-10 | 0.42 pg/mL | Standard Deviation 0.688 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20 :IL-10 | 0.53 pg/mL | Standard Deviation 0.754 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-12 | 0.23 pg/mL | Standard Deviation 0.727 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL-12 | -0.01 pg/mL | Standard Deviation 0.616 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-13 | 2.23 pg/mL | Standard Deviation 2.831 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL-13 | -2.06 pg/mL | Standard Deviation 5.7 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-2 | 1.00 pg/mL | Standard Deviation 1.117 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL-2 | 0.27 pg/mL | Standard Deviation 1.18 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-4 | 0.12 pg/mL | Standard Deviation 0.18 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL-4 | -0.07 pg/mL | Standard Deviation 0.227 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-6 | -0.59 pg/mL | Standard Deviation 18.704 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL-6 | 12.76 pg/mL | Standard Deviation 29.303 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-8 | 0.03 pg/mL | Standard Deviation 0.091 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL-8 | -0.03 pg/mL | Standard Deviation 0.091 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): TNF-α | 2.25 pg/mL | Standard Deviation 2.763 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: TNF-α | 3.20 pg/mL | Standard Deviation 3.099 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL-8 | 0.00 pg/mL | Standard Deviation 0.007 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IFN-γ | 1.70 pg/mL | Standard Deviation 4.251 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-2 | 1.29 pg/mL | Standard Deviation 1.51 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IFN-γ | -0.01 pg/mL | Standard Deviation 2.149 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL-6 | -16.88 pg/mL | Standard Deviation 131.535 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL1-β | 2.68 pg/mL | Standard Deviation 4.548 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL-2 | 0.20 pg/mL | Standard Deviation 0.932 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL1-β | -0.12 pg/mL | Standard Deviation 5.946 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: TNF-α | -1.95 pg/mL | Standard Deviation 33.181 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-10 | 0.80 pg/mL | Standard Deviation 1.135 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-4 | 0.19 pg/mL | Standard Deviation 0.388 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20 :IL-10 | -0.21 pg/mL | Standard Deviation 1.302 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-8 | 0.00 pg/mL | Standard Deviation 0.007 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-12 | -0.03 pg/mL | Standard Deviation 0.755 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL-4 | -0.09 pg/mL | Standard Deviation 0.434 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL-12 | 0.13 pg/mL | Standard Deviation 0.548 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): TNF-α | 11.75 pg/mL | Standard Deviation 27.434 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-13 | 0.94 pg/mL | Standard Deviation 3.504 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Baseline (Day 15/Day 1): IL-6 | 32.06 pg/mL | Standard Deviation 123.405 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Cytokine Secretion by ELISA at Day 20 | Change at Day 20: IL-13 | 0.36 pg/mL | Standard Deviation 1.655 |
Secondary
Change From Baseline in Gliadin-specific T Cell Proliferation by Enzyme-linked Immunosorbent Assay (ELISA) at Day 20
Gliadin-specific T cell proliferation was determined by ELISA test. Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15).
Time frame: Baseline (Day 15/Day 1), Day 20
Population: The pharmacodynamic population included all randomized participants who received two doses of study medication, completed at least the first 3 days of the gluten challenge (12 g/day for 3 days), and had pharmacodynamic results on Study Days 1, 15, and 20. Participants evaluable for this measure at given time point were included for the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Proliferation by Enzyme-linked Immunosorbent Assay (ELISA) at Day 20 | Baseline (Day 15/Day 1) | 0.87 picogram per milliliter (pg/mL) | Standard Deviation 0.275 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gliadin-specific T Cell Proliferation by Enzyme-linked Immunosorbent Assay (ELISA) at Day 20 | Change at Day 20 | 0.05 picogram per milliliter (pg/mL) | Standard Deviation 0.284 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Proliferation by Enzyme-linked Immunosorbent Assay (ELISA) at Day 20 | Baseline (Day 15/Day 1) | 1.00 picogram per milliliter (pg/mL) | Standard Deviation 0.178 |
| Placebo | Change From Baseline in Gliadin-specific T Cell Proliferation by Enzyme-linked Immunosorbent Assay (ELISA) at Day 20 | Change at Day 20 | 0.00 picogram per milliliter (pg/mL) | Standard Deviation 0.18 |
Secondary
Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20
Change from baseline value for Gut-Homing cells like CD4, CD8 and Gamma Delta T-cells were reported. Baseline (Day 15/Day 1) was defined as Day 15 (or Day 1 if enough blood was not available on Day 15). Phenotype (unique cell population) for CD8 cell is EM CD8 \> aE+b7hi \> aE+b7hiCD38+, for CD4 is EM Th \> a4+b7hi \> a4+b7hiCD38+ and for Gamma Delta T-cells is TCRgd T cells \> aE+b7hi \> aE+b7hiCD38+ in this outcome measure.
Time frame: Baseline (Day 15/Day 1), Day 20
Population: The pharmacodynamic population included all randomized participants who received two doses of study medication, completed at least the first 3 days of the gluten challenge (12 g/day for 3 days), and had pharmacodynamic results on Study Days 1, 15, and 20.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Baseline (Day 15/Day 1): CD8 | 0.21 percent parent | Standard Deviation 0.216 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Change at Day 20: CD8 | 0.69 percent parent | Standard Deviation 0.979 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Baseline (Day 15/Day 1): CD4 | 0.19 percent parent | Standard Deviation 0.21 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Change at Day 20: CD4 | 0.26 percent parent | Standard Deviation 0.549 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Baseline (Day 15/Day 1): Gamma Delta T-cells | 0.20 percent parent | Standard Deviation 0.186 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Change at Day 20: Gamma Delta T-cells | 0.15 percent parent | Standard Deviation 0.378 |
| Placebo | Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Baseline (Day 15/Day 1): Gamma Delta T-cells | 0.13 percent parent | Standard Deviation 0.318 |
| Placebo | Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Baseline (Day 15/Day 1): CD8 | 0.18 percent parent | Standard Deviation 0.285 |
| Placebo | Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Change at Day 20: CD4 | 1.05 percent parent | Standard Deviation 1.223 |
| Placebo | Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Change at Day 20: CD8 | 3.64 percent parent | Standard Deviation 3.685 |
| Placebo | Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Change at Day 20: Gamma Delta T-cells | 1.59 percent parent | Standard Deviation 2.598 |
| Placebo | Change From Baseline in Gut-Homing CD4, CD8 and Gamma Delta T-cells by Mass Cytometry (CyTOF) at Day 20 | Baseline (Day 15/Day 1): CD4 | 0.16 percent parent | Standard Deviation 0.189 |
Secondary
Change From Baseline in Number of Intestinal Intraepithelial Lymphocytes (IELs) at Day 29
IELs were white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. Increased intraepithelial lymphocytes was associated with celiac disease. Baseline was defined as the last sample collected prior to the first dose of study medication (Screening Period) on Day 1.
Time frame: Baseline (Screening), Day 29
Population: The histology population included all randomized participants who received two doses of study medication, completed the gluten challenge per protocol, and had both a baseline and Day 29 biopsy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Change From Baseline in Number of Intestinal Intraepithelial Lymphocytes (IELs) at Day 29 | Baseline (Screening): IELs | 39.62 cells per 100 enterocytes | Standard Deviation 18.842 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Number of Intestinal Intraepithelial Lymphocytes (IELs) at Day 29 | Change at Day 29: IELs | 28.62 cells per 100 enterocytes | Standard Deviation 19.241 |
| Placebo | Change From Baseline in Number of Intestinal Intraepithelial Lymphocytes (IELs) at Day 29 | Baseline (Screening): IELs | 34.53 cells per 100 enterocytes | Standard Deviation 12.389 |
| Placebo | Change From Baseline in Number of Intestinal Intraepithelial Lymphocytes (IELs) at Day 29 | Change at Day 29: IELs | 35.00 cells per 100 enterocytes | Standard Deviation 18.756 |
p-value: 0.289Wilcoxon Rank Sum test
Secondary
Change From Baseline in Ratio of Villus Height to Crypt Depth (Vh:Cd) at Day 29
Attenuation of the effects of gluten exposure was assessed by measuring the change from baseline in villous height (Vh) to crypt depth (Cd) ratio after 29 days of gluten challenge. Villi were the small finger like projections that line the small intestine and promote nutrient absorption and are often shortened in participants with CD. Crypts are grooves between the villi that are often elongated in participants with CD. A decreased Vh:Cd ratio indicates worsening disease. Baseline was defined as the last sample collected prior to the first dose of study medication (Screening Period) on Day 1.
Time frame: Baseline (Screening), Day 29
Population: The histology population included all randomized participants who received two doses of study medication, completed the gluten challenge per protocol, and had both a baseline and Day 29 biopsy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Change From Baseline in Ratio of Villus Height to Crypt Depth (Vh:Cd) at Day 29 | Baseline (Screening): Vh:Cd | 2.82 ratio | Standard Deviation 0.306 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Ratio of Villus Height to Crypt Depth (Vh:Cd) at Day 29 | Change at Day 29: Vh:Cd: | -0.18 ratio | Standard Deviation 0.381 |
| Placebo | Change From Baseline in Ratio of Villus Height to Crypt Depth (Vh:Cd) at Day 29 | Baseline (Screening): Vh:Cd | 3.01 ratio | Standard Deviation 0.451 |
| Placebo | Change From Baseline in Ratio of Villus Height to Crypt Depth (Vh:Cd) at Day 29 | Change at Day 29: Vh:Cd: | -0.63 ratio | Standard Deviation 0.657 |
p-value: 0.0799Wilcoxon Rank Sum test
Secondary
Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35
Baseline was defined as the pre-dose value on Day 1.
Time frame: Baseline (Day 1), Days 15, 20, 29, and 35
Population: The safety population included all randomized participants who received at least one dose of study medication. Participants who were evaluable for this measure at given time point were included for the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35 | Change at Day 15 | 0.64 units per milliliter (U/mL) | Standard Deviation 1.249 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35 | Change at Day 29 | 0.10 units per milliliter (U/mL) | Standard Deviation 1.901 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35 | Change at Day 20 | 0.88 units per milliliter (U/mL) | Standard Deviation 1.315 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35 | Change at Day 35 | 0.49 units per milliliter (U/mL) | Standard Deviation 1.31 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35 | Baseline (Day 1) | 3.65 units per milliliter (U/mL) | Standard Deviation 2.026 |
| Placebo | Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35 | Change at Day 35 | 0.09 units per milliliter (U/mL) | Standard Deviation 2.116 |
| Placebo | Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35 | Baseline (Day 1) | 4.53 units per milliliter (U/mL) | Standard Deviation 1.962 |
| Placebo | Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35 | Change at Day 15 | 0.21 units per milliliter (U/mL) | Standard Deviation 1.498 |
| Placebo | Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35 | Change at Day 20 | -0.15 units per milliliter (U/mL) | Standard Deviation 1.274 |
| Placebo | Change From Baseline in Serum Complement Levels of C1q Binding at Days 15, 20, 29, and 35 | Change at Day 29 | 0.18 units per milliliter (U/mL) | Standard Deviation 2.073 |
Secondary
Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15
Baseline was defined as the pre-dose value on Day 1.
Time frame: Baseline (Day 1), Days 2, 8, 9, and 15
Population: The safety population included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Baseline (Day 1): C3a | 1024.0 ng/mL | Standard Deviation 430.15 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 2: C3a | -144.6 ng/mL | Standard Deviation 452.51 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 8: C3a | 244.7 ng/mL | Standard Deviation 449.2 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 9: C3a | -63.0 ng/mL | Standard Deviation 227.28 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 15: C3a | -165.2 ng/mL | Standard Deviation 308.01 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Baseline (Day 1): SC5B-9 | 130.5 ng/mL | Standard Deviation 44.69 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 2: SC5B-9 | -8.7 ng/mL | Standard Deviation 25.83 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 8: SC5B-9 | 866.5 ng/mL | Standard Deviation 924.08 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 9: SC5B-9 | 40.5 ng/mL | Standard Deviation 137.83 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 15: SC5B-9 | 5.5 ng/mL | Standard Deviation 57.06 |
| Placebo | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 8: SC5B-9 | -4.6 ng/mL | Standard Deviation 28.72 |
| Placebo | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Baseline (Day 1): C3a | 1069.9 ng/mL | Standard Deviation 435.78 |
| Placebo | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Baseline (Day 1): SC5B-9 | 114.7 ng/mL | Standard Deviation 40.68 |
| Placebo | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 2: C3a | 112.3 ng/mL | Standard Deviation 1086.95 |
| Placebo | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 15: SC5B-9 | 18.4 ng/mL | Standard Deviation 53.46 |
| Placebo | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 8: C3a | -115.3 ng/mL | Standard Deviation 385.44 |
| Placebo | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 2: SC5B-9 | -4.5 ng/mL | Standard Deviation 20.18 |
| Placebo | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 9: C3a | -71.2 ng/mL | Standard Deviation 441.8 |
| Placebo | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 9: SC5B-9 | -4.8 ng/mL | Standard Deviation 37.18 |
| Placebo | Change From Baseline in Serum Complement Levels of C3a and SC5B-9 at Days 2, 8, 9, and 15 | Change at Day 15: C3a | 54.8 ng/mL | Standard Deviation 603.56 |
Secondary
Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15
Baseline was defined as the pre-dose value on Day 1.
Time frame: Baseline (Day 1) , Days 2, 8, 9, and 15
Population: The safety population included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15 | Change at Day 2 | 0.763 microgram per liter (mcg/L) | Standard Deviation 1.0587 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15 | Change at Day 9 | 0.926 microgram per liter (mcg/L) | Standard Deviation 1.3873 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15 | Change at Day 8 | 8.373 microgram per liter (mcg/L) | Standard Deviation 8.0077 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15 | Change at Day 15 | 0.319 microgram per liter (mcg/L) | Standard Deviation 1.7868 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15 | Baseline (Day 1) | 9.290 microgram per liter (mcg/L) | Standard Deviation 6.5091 |
| Placebo | Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15 | Change at Day 15 | 0.241 microgram per liter (mcg/L) | Standard Deviation 0.9151 |
| Placebo | Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15 | Baseline (Day 1) | 7.267 microgram per liter (mcg/L) | Standard Deviation 3.2526 |
| Placebo | Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15 | Change at Day 2 | -0.067 microgram per liter (mcg/L) | Standard Deviation 0.6776 |
| Placebo | Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15 | Change at Day 8 | 0.082 microgram per liter (mcg/L) | Standard Deviation 0.7604 |
| Placebo | Change From Baseline in Serum Complement Levels of C5a at Days 2, 8, 9, and 15 | Change at Day 9 | 0.347 microgram per liter (mcg/L) | Standard Deviation 1.0356 |
Secondary
Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15
Baseline was defined as Day 1 pre-dose. A negative change from baseline value was reported when the observed sample response was less than the observed background response.
Time frame: Baseline (Day 1), Days 2, 8, 9, and 15
Population: The safety population included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL-12p70 | 0.0000 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL-12p70 | 0.0000 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL-12p70 | 0.0000 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL-12p70 | 0.0000 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): TNF-α | 2.856 pg/mL | Standard Deviation 0.6101 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: TNF-α | 1.218 pg/mL | Standard Deviation 1.1446 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: TNF-α | 0.132 pg/mL | Standard Deviation 0.5762 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: TNF-α | 0.801 pg/mL | Standard Deviation 0.7369 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: TNF-α | 0.138 pg/mL | Standard Deviation 0.7129 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IFN-γ | 7.375 pg/mL | Standard Deviation 9.5787 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IFN-γ | 9.871 pg/mL | Standard Deviation 19.3167 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IFN-γ | -2.374 pg/mL | Standard Deviation 10.3311 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IFN-γ | 1.663 pg/mL | Standard Deviation 14.7044 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IFN-γ | 0.539 pg/mL | Standard Deviation 12.8988 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL1-β | 0.600 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL1-β | 0.000 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL1-β | 0.000 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL1-β | 0.000 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL1-β | 0.000 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL-2 | 0.731 pg/mL | Standard Deviation 0.045 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL-2 | 0.004 pg/mL | Standard Deviation 0.0175 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL-2 | 0.008 pg/mL | Standard Deviation 0.0325 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL-2 | 0.006 pg/mL | Standard Deviation 0.025 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL-2 | 0.006 pg/mL | Standard Deviation 0.025 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL-4 | 0.380 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL-4 | 0.000 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL-4 | 0.000 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL-4 | 0.000 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL-4 | 0.000 pg/mL | Standard Deviation 0 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL-6 | 1.067 pg/mL | Standard Deviation 0.3473 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL-6 | -0.009 pg/mL | Standard Deviation 0.0924 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL-6 | 0.024 pg/mL | Standard Deviation 0.3507 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL-6 | 0.159 pg/mL | Standard Deviation 0.4817 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL-6 | -0.059 pg/mL | Standard Deviation 0.3768 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL-8 | 12.602 pg/mL | Standard Deviation 5.7067 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL-8 | 11.159 pg/mL | Standard Deviation 17.5276 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL-8 | -0.470 pg/mL | Standard Deviation 3.1986 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL-8 | 5.816 pg/mL | Standard Deviation 9.5328 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL-8 | -1.959 pg/mL | Standard Deviation 5.0839 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL-10 | 1.784 pg/mL | Standard Deviation 5.4054 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL-10 | 0.081 pg/mL | Standard Deviation 0.0969 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL-10 | -0.040 pg/mL | Standard Deviation 0.2209 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL-10 | 0.494 pg/mL | Standard Deviation 1.2476 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL-10 | 0.307 pg/mL | Standard Deviation 1.0885 |
| TIMP-GLIA 8 mg/kg | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL-12p70 | 3.280 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL-2 | -0.022 pg/mL | Standard Deviation 0.0943 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL-12p70 | 0.0000 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL-10 | 0.449 pg/mL | Standard Deviation 0.1651 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL-12p70 | 0.0000 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL-2 | -0.023 pg/mL | Standard Deviation 0.099 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL-12p70 | 0.0000 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL-8 | 11.497 pg/mL | Standard Deviation 3.9699 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL-12p70 | 0.0000 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL-4 | 0.380 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): TNF-α | 2.421 pg/mL | Standard Deviation 0.6177 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL-10 | 0.067 pg/mL | Standard Deviation 0.1695 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: TNF-α | -0.037 pg/mL | Standard Deviation 0.4394 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL-4 | 0.0000 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: TNF-α | 0.080 pg/mL | Standard Deviation 0.3451 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL-8 | 0.236 pg/mL | Standard Deviation 5.6791 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: TNF-α | -0.043 pg/mL | Standard Deviation 0.394 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL-4 | 0.0000 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: TNF-α | 0.083 pg/mL | Standard Deviation 0.2492 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL-10 | 0.042 pg/mL | Standard Deviation 0.1403 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IFN-γ | 4.592 pg/mL | Standard Deviation 1.9801 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL-4 | 0.0000 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IFN-γ | -0.179 pg/mL | Standard Deviation 0.8403 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL-8 | -2.177 pg/mL | Standard Deviation 3.1075 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IFN-γ | 5.245 pg/mL | Standard Deviation 15.7119 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL-4 | 0.0000 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IFN-γ | 3.709 pg/mL | Standard Deviation 12.0744 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL-12p70 | 3.280 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IFN-γ | 0.871 pg/mL | Standard Deviation 2.4732 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL-6 | 1.005 pg/mL | Standard Deviation 0.1621 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL1-β | 0.600 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL-8 | -1.685 pg/mL | Standard Deviation 4.1328 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL1-β | 0.0000 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL-6 | 0.069 pg/mL | Standard Deviation 0.2733 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL1-β | 0.0000 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL-10 | 0.017 pg/mL | Standard Deviation 0.1701 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL1-β | 0.0000 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL-6 | 0.169 pg/mL | Standard Deviation 0.6991 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL1-β | 0.0000 pg/mL | Standard Deviation 0 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL-8 | -1.394 pg/mL | Standard Deviation 4.0435 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Baseline (Day 1): IL-2 | 0.824 pg/mL | Standard Deviation 0.4431 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 9: IL-6 | 0.051 pg/mL | Standard Deviation 0.233 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 2: IL-2 | 0.001 pg/mL | Standard Deviation 0.0047 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL-10 | -0.013 pg/mL | Standard Deviation 0.0531 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 8: IL-2 | -0.021 pg/mL | Standard Deviation 0.0872 |
| Placebo | Change From Baseline in Serum Cytokines (IFN-γ, IL 1-β, IL-2, IL-4, IL-6, IL-8 , IL-10, IL-12p70, and TNF-Alpha) at Days 2, 8, 9, and 15 | Change at Day 15: IL-6 | -0.008 pg/mL | Standard Deviation 0.14 |
Secondary
Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment
The CSI were clinically oriented, easily administered, questionnaires with 16 items. The modified CSI (6-items) was derived from a subset of questions from the CSI questionnaire, including the diarrhea, nausea, rumbling in stomach, stomach felt bloated, diarrhea and low energy level abdominal pain domains (a total of 6 questions), which were each assessed on a scale of 1 to 5- none of the time, a little of the time, some of the time, most of the time and all of the time respectively. Higher CSI scores correlate with more severe CD symptoms. It is to be used to assess symptoms before, during, and after the oral gluten challenge. Here D refers to Day.
Time frame: Days 15, 20, 29 and 35
Population: The safety population included all randomized participants who received at least one dose of study medication. Here, number analyzed signifies the participants who were evaluable for this outcome measure for given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Pain/discomfort in abdomen/stomach: None | 6 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Pain/discomfort in abdomen/stomach: A little | 3 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Pain/discomfort in abdomen/stomach: A little | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Pain/discomfort in abdomen/stomach: None | 5 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Pain/discomfort in abdomen/stomach: Some | 4 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Stomach felt bloated: None | 11 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Pain/discomfort in abdomen/stomach: Most | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Pain/discomfort in abdomen/stomach: A little | 4 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Pain/discomfort in abdomen/stomach: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Nausea: None | 12 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Nausea: None | 8 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Pain/discomfort in abdomen/stomach: Some | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Nausea: A little | 3 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Stomach felt bloated: A little | 4 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Nausea: Some | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Pain/discomfort in abdomen/stomach: Most | 3 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Nausea: Most | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Nausea: Most | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Nausea: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Pain/discomfort in abdomen/stomach: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Rumbling in stomach: None | 7 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Stomach felt bloated: Some | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Rumbling in stomach: A little | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Nausea: None | 4 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Rumbling in stomach: Some | 3 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Pain/discomfort in abdomen/stomach: Some | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Rumbling in stomach: Most | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Nausea: A little | 5 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Rumbling in stomach: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Stomach felt bloated: Most | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Stomach felt bloated: None | 7 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Nausea: Some | 3 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Stomach felt bloated: A little | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Nausea: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Stomach felt bloated: Some | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Nausea: Most | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Stomach felt bloated: Most | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Stomach felt bloated: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Stomach felt bloated: All time | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Nausea: All time | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Diarrhea: None | 10 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Nausea: A little | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Diarrhea: A little | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Rumbling in stomach: None | 6 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Diarrhea: Some | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Diarrhea: None | 14 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Diarrhea: Most | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Rumbling in stomach: A little | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Diarrhea: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Rumbling in stomach: None | 12 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Low energy level: None | 4 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Rumbling in stomach: Some | 4 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Low energy level: A little | 3 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Diarrhea: A little | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Low energy level: Some | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Rumbling in stomach: Most | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Low energy level: Most | 3 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Pain/discomfort in abdomen/stomach: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Low energy level: All time | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Rumbling in stomach: All time | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Pain/discomfort in abdomen/stomach: None | 8 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Diarrhea: Some | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Pain/discomfort in abdomen/stomach: A little | 4 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Stomach felt bloated: None | 7 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Pain/discomfort in abdomen/stomach: Some | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Rumbling in stomach: A little | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Pain/discomfort in abdomen/stomach: Most | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Stomach felt bloated: A little | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Pain/discomfort in abdomen/stomach: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Diarrhea: Most | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Nausea: None | 9 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Stomach felt bloated: Some | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Nausea: A little | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Nausea: Some | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Nausea: Some | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Stomach felt bloated: Most | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Nausea: Most | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Diarrhea: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Nausea: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Stomach felt bloated: All time | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Rumbling in stomach: None | 10 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Rumbling in stomach: Some | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Rumbling in stomach: A little | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Diarrhea: None | 8 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Rumbling in stomach: Some | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Low energy level: None | 6 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Rumbling in stomach: Most | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Diarrhea: A little | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Rumbling in stomach: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Pain/discomfort in abdomen/stomach: None | 11 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Stomach felt bloated: None | 8 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Diarrhea: Some | 3 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Stomach felt bloated: A little | 3 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Diarrhea: Most | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Stomach felt bloated: Some | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Low energy level: A little | 5 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Stomach felt bloated: Most | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Diarrhea: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Stomach felt bloated: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Rumbling in stomach: Most | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Diarrhea: None | 11 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Low energy level: None | 3 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Diarrhea: A little | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Low energy level: Some | 3 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Diarrhea: Some | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Low energy level: A little | 5 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Diarrhea: Most | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Pain/discomfort in abdomen/stomach: Most | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Diarrhea: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Low energy level: Some | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Low energy level: None | 7 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Low energy level: Most | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Low energy level: A little | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Low energy level: Most | 4 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Low energy level: Some | 4 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Rumbling in stomach: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Low energy level: Most | 1 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Low energy level: All time | 2 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Low energy level: All time | 0 participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Low energy level: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Low energy level: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Pain/discomfort in abdomen/stomach: A little | 4 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Pain/discomfort in abdomen/stomach: Some | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Pain/discomfort in abdomen/stomach: Most | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Pain/discomfort in abdomen/stomach: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Nausea: None | 15 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Nausea: A little | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Pain/discomfort in abdomen/stomach: None | 13 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Nausea: Some | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Nausea: Most | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Nausea: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Rumbling in stomach: None | 11 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Rumbling in stomach: A little | 5 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Rumbling in stomach: Some | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Rumbling in stomach: Most | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Rumbling in stomach: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Stomach felt bloated: None | 10 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Stomach felt bloated: A little | 7 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Stomach felt bloated: Some | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Stomach felt bloated: Most | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Stomach felt bloated: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Diarrhea: None | 15 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Diarrhea: A little | 3 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Diarrhea: Some | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Diarrhea: Most | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Diarrhea: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Low energy level: None | 11 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Low energy level: A little | 5 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Low energy level: Some | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Low energy level: Most | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 15, Low energy level: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Pain/discomfort in abdomen/stomach: None | 8 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Pain/discomfort in abdomen/stomach: A little | 3 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Pain/discomfort in abdomen/stomach: Some | 4 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Pain/discomfort in abdomen/stomach: Most | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Pain/discomfort in abdomen/stomach: All time | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Nausea: None | 5 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Nausea: A little | 7 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Nausea: Some | 3 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Nausea: Most | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Nausea: All time | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Rumbling in stomach: None | 6 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Rumbling in stomach: A little | 6 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Rumbling in stomach: Some | 3 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Rumbling in stomach: Most | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Rumbling in stomach: All time | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Stomach felt bloated: None | 4 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Stomach felt bloated: A little | 8 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Stomach felt bloated: Some | 3 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Stomach felt bloated: Most | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Stomach felt bloated: All time | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Diarrhea: None | 11 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Diarrhea: A little | 4 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Diarrhea: Most | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Diarrhea: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Low energy level: None | 6 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Low energy level: A little | 6 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Low energy level: Some | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Low energy level: Most | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Low energy level: All time | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Pain/discomfort in abdomen/stomach: None | 10 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Pain/discomfort in abdomen/stomach: A little | 5 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Pain/discomfort in abdomen/stomach: Some | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Pain/discomfort in abdomen/stomach: Most | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Pain/discomfort in abdomen/stomach: All time | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Nausea: None | 9 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Nausea: A little | 5 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Nausea: Some | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Nausea: Most | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Nausea: All time | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Rumbling in stomach: None | 9 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Rumbling in stomach: A little | 5 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Rumbling in stomach: Some | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Rumbling in stomach: Most | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Rumbling in stomach: All time | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Stomach felt bloated: None | 8 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Stomach felt bloated: A little | 6 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Stomach felt bloated: Some | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Stomach felt bloated: Most | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Stomach felt bloated: All time | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Diarrhea: None | 13 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Diarrhea: A little | 3 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Diarrhea: Some | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Diarrhea: Most | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Diarrhea: All time | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Low energy level: None | 8 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Low energy level: A little | 6 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Low energy level: Some | 3 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Low energy level: Most | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 29, Low energy level: All time | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Pain/discomfort in abdomen/stomach: None | 15 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Pain/discomfort in abdomen/stomach: A little | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Pain/discomfort in abdomen/stomach: Some | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Pain/discomfort in abdomen/stomach: Most | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Pain/discomfort in abdomen/stomach: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Nausea: None | 16 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Nausea: A little | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Nausea: Some | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Nausea: Most | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Nausea: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Rumbling in stomach: None | 11 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Rumbling in stomach: A little | 7 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Rumbling in stomach: Some | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Rumbling in stomach: Most | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Rumbling in stomach: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Stomach felt bloated: None | 10 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Stomach felt bloated: A little | 6 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Stomach felt bloated: Some | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Stomach felt bloated: Most | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Stomach felt bloated: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Diarrhea: None | 14 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Diarrhea: A little | 3 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Diarrhea: Some | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Diarrhea: Most | 1 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Diarrhea: All time | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Low energy level: None | 14 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Low energy level: A little | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Low energy level: Some | 0 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 35, Low energy level: Most | 2 participants |
| Placebo | Number of Participants Based on Celiac Symptom Index-Modified (CSI-M) Questionnaire Results by Treatment | D 20, Diarrhea: Some | 3 participants |
Secondary
Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Time frame: From the first dose of study drug up to Day 35
Population: The safety population included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 16 Participants |
| TIMP-GLIA 8 mg/kg | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 Participants |
| Placebo | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE | 18 Participants |
| Placebo | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 Participants |
Secondary
Number of Participants With Clinically Significant Change From Baseline in Hematology or Serum Chemistry Laboratory Values
Time frame: From the first dose of study drug up to Day 35
Population: The safety population included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TIMP-GLIA 8 mg/kg | Number of Participants With Clinically Significant Change From Baseline in Hematology or Serum Chemistry Laboratory Values | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Change From Baseline in Hematology or Serum Chemistry Laboratory Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: From the first dose of study drug up to Day 35
Population: The safety population included all randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TIMP-GLIA 8 mg/kg | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
Secondary
Percentage of Participants With Greater Than or Equal to (>=) 0.4 Decrease in Vh:Cd at Day 29
Villi were the small finger like projections that line the small intestine and promote nutrient absorption and are often shortened in participants with CD. Crypts are grooves between the villi that are often elongated in participants with CD. A decreased Vh:Cd ratio indicates worsening disease.
Time frame: Day 29
Population: The histology population included all randomized participants who received two doses of study medication, completed the gluten challenge per protocol, and had both a baseline and Day 29 biopsy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TIMP-GLIA 8 mg/kg | Percentage of Participants With Greater Than or Equal to (>=) 0.4 Decrease in Vh:Cd at Day 29 | 23.1 percentage of participants |
| Placebo | Percentage of Participants With Greater Than or Equal to (>=) 0.4 Decrease in Vh:Cd at Day 29 | 53.3 percentage of participants |
Secondary
Plasma Concentrations of TIMP-GLIA
Time frame: Day 8: 0 hours (pre-infusion), end of infusion, and at 2 hours post-infusion
Population: The pharmacokinetic population included all randomized participants who received two doses of study medication and had at least one reported concentration. The pharmacokinetic population where data at specified time points were available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIMP-GLIA 8 mg/kg | Plasma Concentrations of TIMP-GLIA | 0 hours (pre-infusion) | 13.06 nanogram per milliliter (ng/mL) | Standard Deviation 52.25 |
| TIMP-GLIA 8 mg/kg | Plasma Concentrations of TIMP-GLIA | End of Infusion | 684.54 nanogram per milliliter (ng/mL) | Standard Deviation 319.069 |
| TIMP-GLIA 8 mg/kg | Plasma Concentrations of TIMP-GLIA | 2 hours post infusion | 383.46 nanogram per milliliter (ng/mL) | Standard Deviation 153.225 |