Eosinophilic Esophagitis
Conditions
Keywords
EoE
Brief summary
The purpose of this study is to asses the efficacy, safety and tolerability of repeat doses of IRL201104 in Adult Participants with Active Eosinophilic Esophagitis (EoE)
Interventions
DRUGIRL201104
lyophilised powder for reconstitution for IV dosing
DRUGPlacebo
Matching placebo for IRL201104
Sponsors
Revolo Biotherapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 75 years old, inclusive, at the time of signing the informed consent form. 2. Documented diagnosis of EoE by endoscopy prior to screening. Note: Must include a demonstration of intraepithelial eosinophilic infiltration (peak cell count ≥ 15 eos/hpf \[400×\]) from esophageal biopsy specimens from endoscopy. 3. History (by participant report) of on average at least 2 episodes of dysphagia (with intake of solids off anti-inflammatory therapy) per week in the 4 weeks prior to screening, and on average at least 2 episodes of documented dysphagia per week during any 2 consecutive weeks (qualifying period) between screening and baseline; dysphagia is defined as trouble swallowing solid food, or having solid food stick, by participant report; and completed the DSQ on ≥ 70% of days during the qualifying period prior to baseline (Visit 1). 4. Must remain on a stabilized diet for at least 6 weeks prior to screening and during the course of the study; stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups. 5. Must be willing and able to continue any dietary therapy and/or medical regimens (including gastric acid suppression) in effect at the screening visit. There should be no change to these regimens during the study participation. 6. Willing and able to comply with all clinic visits and study-related procedures. 7. Able to understand and complete study-related questionnaires. 8. Provide signed informed consent. 9. Esophagogastroduodenoscopy (EGD) with photographs performed at screening (qualifying EGD), with a demonstration of intraepithelial eosinophilic infiltration (peak cell count ≥15 eos/hpf) in at least 2 of the 3 biopsied esophageal regions (proximal, mid, or distal).
Exclusion criteria
1. Prior participation in an IRL201104 clinical study. 2. Has any current disease of the gastrointestinal tract (aside from EoE) that may impact, in the investigator's opinion, the patient's EoE disease status. This includes, but not limited to: eosinophilic gastritis, eosinophilic enteritis, eosinophilic duodenitis, eosinophilic colitis, or proctitis; inflammatory bowel disease; or celiac disease. 3. Has other causes of esophageal eosinophilia or the following diseases: hypereosinophilic syndromes, Churg-Strauss vasculitis (eosinophilic granulomatosis with polyangiitis), or peripheral blood absolute eosinophil count of \> 1500 eosinophils/μL. 4. Has presence of oral or esophageal mucosal infection of any type. 5. Has any condition affecting the esophageal mucosa or altering esophageal motility other than EoE. 6. History of achalasia, active Helicobacter pylori infection, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery (with the exception of a surgical repair of an EoE complication). 7. Any esophageal stricture unable to be passed with a standard, diagnostic, adult (9 to 10 mm) upper endoscope or any critical esophageal stricture that requires dilation at screening; or dilation within 2 months prior to screening. 8. On a pure liquid diet or any mouth or dental condition that prevents normal eating. 9. Has initiated, discontinued, or changed dosage regimen of PPIs within the 4 weeks prior to the qualifying EGD, between the qualifying EGD and baseline visit (Visit 1), or anticipates changes in the use of PPI during the study. PPI must remain constant throughout the study. 10. History of bleeding disorders or esophageal varices. 11. Use of anticoagulants within 2 weeks prior to screening. Participants should not stop these agents solely to become eligible for entry into this study. 12. Treatment with an investigational drug within 2 months or within 5 half-lives (if known), whichever is longer, prior to screening. 13. Use of systemic corticosteroids within 3 months or swallowed topical corticosteroids within 6 weeks prior to screening. 14. Treatment with oral immunotherapy (OIT) within 6 months prior to screening. 15. Allergen immunotherapy (sublingual immunotherapy \[SLIT\] and/or subcutaneous immunotherapy \[SCIT\]), unless on a stable dose for at least 1 year prior to screening. 16. The following treatments within 3 months before the screening visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the study: Systemic immunosuppressive/immunomodulating drugs (eg, omalizumab, cyclosporine, mycophenolate-mofetil, interferon \[IFN\]γ, Janus kinase inhibitors, azathioprine, methotrexate, and other biologics that are ongoing \[eg, dupilumab, benralizumab, mepolizumab, or vedolizumab\]). 17. Diagnosed with active parasitic infection; or suspected parasitic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before randomization. 18. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening. 19. Use of oral antibiotics/anti-infectives within 2 weeks prior to screening. 20. Known or suspected immunosuppression, including history of invasive opportunistic infections (eg, tuberculosis, non-tuberculous mycobacterial infections, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immunocompromised status, as judged by the investigator. 21. Known history of human immunodeficiency virus (HIV) infection. 22. Positive or indeterminate hepatitis B surface antigen (HBsAg) or hepatitis C antibody at screening. 23. Moderate or severe renal impairment (eGFR \<60 mL/min/1.73 m2) or end stage renal disease. 24. Elevated transaminases (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]) \> 3 times the upper limit of normal (ULN) at screening. 25. History of malignancy within 5 years prior to screening, except completely treated in situ carcinoma of the cervix and completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin. 26. Any other medical or psychological condition including relevant laboratory abnormalities at screening that, in the opinion of the investigator, suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the participant as a result of his/her participation in this clinical study, may make the participant's participation unreliable, or may interfere with study assessments. The specific justification for participants excluded under this criterion will be noted in study documents (eg, chart notes, electronic case report form). These may include participant-reported alcohol or drug abuse and severe concomitant illness(es). 27. Planned or anticipated use of any prohibited medications and procedures (as described in the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Peak Esophageal Intraepithelial Eosinophil Count at Week 4 (Mean) | 4 weeks | The change from baseline in histologic eosinophil count in each treatment group will be summarized as the mean and Standard Deviation (SD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of < 15 Eos/Hpf (Week 4) | 4 weeks | Percent of participants with a histologic eosinophil count of \< 15 eos/hpf will be summarized for each treatment group |
| Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) | 4 weeks | The percent change from baseline in peak intraepithelial eosinophil count in each treatment group will be summarized as the mean and SD |
| Treatment Emergent Adverse Events (TEAE) | 8 weeks | Number of participants who had a TEAE |
| Safety Laboratory Data: Biochemistry | 8 weeks | Number of participants with treatment emergent clinically significant abnormal lab value. |
| Safety Laboratory Data: Coagulation | 8 weeks | Number of participants with treatment emergent clinically significant abnormal lab value |
| Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline. | 4 weeks | The DSQ is used to measure the frequency and intensity of dysphagia. The DSQ scores can range from 0 to 84, with a lower score indicating less frequent or less severe dysphagia. The change from baseline in DSQ score in each treatment group will be summarized as the median, minimum, and maximum |
| Safety Laboratory Data: Urinalysis Panel | 8 weeks | Number of participants with treatment emergent clinically significant abnormal value (Color, Glucose, Red blood cells, Clarity, Blood, Hyaline and other casts, pH, Bilirubin, Bacteria, Specific gravity, Leukocyte esterase, Epithelial cells, Ketones, Nitrite, Crystals, Protein, White blood cells, Yeast). |
| 12-Lead ECG | 8 weeks | Number of participants with treatment emergent clinically significant abnormal value (Ventricular Rate, PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval). |
| Physical Exam | 8 weeks | Number of participants with treatment emergent clinically significant abnormal value \[Body Systems: head, eyes, ears, nose and throat (HEENT); cardiovascular, respiratory, gastrointestinal, dermatological, musculoskeletal, nervous systems, lymph nodes and general appearance\]. |
| Vital Signs | 8 weeks | Number of participants with treatment emergent clinically significant abnormal value (systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature). |
| Safety Laboratory Data: Hematology Panel | 8 weeks | Number of participants with treatment emergent clinically significant abnormal value \[Hemoglobin, Hematocrit, red blood cells count, white blood cell count, red cell indices, platelet count and white blood cell differential (neutrophil, lymphocyte, monocyte, eosinophil, and basophil)\]. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: IRL201104 4 mg IRL201104 IV on Days 0, 7, and 14
IRL201104: lyophilised powder for reconstitution for IV dosing | 11 |
| Arm 2: IRL201104 8 mg IRL201104 IV on Days 0, 7, and 14
IRL201104: lyophilised powder for reconstitution for IV dosing | 13 |
| Arm 3: Placebo Placebo IV on Days 0, 7, and 14
Placebo: Matching placebo for IRL201104 | 12 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Arm 1: IRL201104 4 mg | Total | Arm 3: Placebo | Arm 2: IRL201104 8 mg |
|---|---|---|---|---|
| Age, Continuous | 39 years | 38.5 years | 33 years | 42 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 36 Participants | 12 Participants | 13 Participants |
| Region of Enrollment United States | 11 participants | 36 participants | 12 participants | 13 participants |
| Sex: Female, Male Female | 2 Participants | 10 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 9 Participants | 26 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 6 / 11 | 7 / 13 | 7 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 13 | 0 / 12 |
Outcome results
Primary
Change From Baseline in the Peak Esophageal Intraepithelial Eosinophil Count at Week 4 (Mean)
The change from baseline in histologic eosinophil count in each treatment group will be summarized as the mean and Standard Deviation (SD)
Time frame: 4 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: IRL201104 4 mg | Change From Baseline in the Peak Esophageal Intraepithelial Eosinophil Count at Week 4 (Mean) | -9.2 eosinophil count per high power field | Standard Deviation 87.95 |
| Arm 2: IRL201104 8 mg | Change From Baseline in the Peak Esophageal Intraepithelial Eosinophil Count at Week 4 (Mean) | -31.6 eosinophil count per high power field | Standard Deviation 68.09 |
| Arm 3: Placebo | Change From Baseline in the Peak Esophageal Intraepithelial Eosinophil Count at Week 4 (Mean) | -7.8 eosinophil count per high power field | Standard Deviation 104.02 |
Secondary
12-Lead ECG
Number of participants with treatment emergent clinically significant abnormal value (Ventricular Rate, PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval).
Time frame: 8 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: IRL201104 4 mg | 12-Lead ECG | 0 Participants |
| Arm 2: IRL201104 8 mg | 12-Lead ECG | 0 Participants |
| Arm 3: Placebo | 12-Lead ECG | 0 Participants |
Secondary
Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline.
The DSQ is used to measure the frequency and intensity of dysphagia. The DSQ scores can range from 0 to 84, with a lower score indicating less frequent or less severe dysphagia. The change from baseline in DSQ score in each treatment group will be summarized as the median, minimum, and maximum
Time frame: 4 weeks
Population: Analysis performed on Full Analysis Set participants with non-missing DSQ data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm 1: IRL201104 4 mg | Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline. | -15.000 score on a scale |
| Arm 2: IRL201104 8 mg | Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline. | -6.937 score on a scale |
| Arm 3: Placebo | Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline. | -3.909 score on a scale |
Secondary
Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf)
The percent change from baseline in peak intraepithelial eosinophil count in each treatment group will be summarized as the mean and SD
Time frame: 4 weeks
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: IRL201104 4 mg | Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) | 31.061 percent change | Standard Deviation 83.858 |
| Arm 2: IRL201104 8 mg | Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) | -19.007 percent change | Standard Deviation 39.716 |
| Arm 3: Placebo | Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) | 44.306 percent change | Standard Deviation 197.449 |
Secondary
Percent of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of < 15 Eos/Hpf (Week 4)
Percent of participants with a histologic eosinophil count of \< 15 eos/hpf will be summarized for each treatment group
Time frame: 4 weeks
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: IRL201104 4 mg | Percent of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of < 15 Eos/Hpf (Week 4) | 0 Participants |
| Arm 2: IRL201104 8 mg | Percent of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of < 15 Eos/Hpf (Week 4) | 1 Participants |
| Arm 3: Placebo | Percent of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of < 15 Eos/Hpf (Week 4) | 1 Participants |
Secondary
Physical Exam
Number of participants with treatment emergent clinically significant abnormal value \[Body Systems: head, eyes, ears, nose and throat (HEENT); cardiovascular, respiratory, gastrointestinal, dermatological, musculoskeletal, nervous systems, lymph nodes and general appearance\].
Time frame: 8 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: IRL201104 4 mg | Physical Exam | 0 Participants |
| Arm 2: IRL201104 8 mg | Physical Exam | 0 Participants |
| Arm 3: Placebo | Physical Exam | 0 Participants |
Secondary
Safety Laboratory Data: Biochemistry
Number of participants with treatment emergent clinically significant abnormal lab value.
Time frame: 8 weeks
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Glucose | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Total Protein | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Alanine aminotransferase | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Triglycerides | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Potassium | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Albumin | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Low-Density Lipoprotein | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Creatinine | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Alkaline phosphatase | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | High-Density Lipoprotein | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Total Cholesterol | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Aspartate aminotransferase | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Calcium | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Carbon dioxide | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Total Bilirubin | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Creatine Kinase | 1 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Blood Urea Nitrogen | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Indirect Bilirubin | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Lactate dehydrogenase | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Chloride | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Sodium | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Biochemistry | Uric acid | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Calcium | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Carbon dioxide | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Creatine Kinase | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Alanine aminotransferase | 1 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Aspartate aminotransferase | 1 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Total Bilirubin | 1 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Indirect Bilirubin | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Sodium | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Total Protein | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Potassium | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Creatinine | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Total Cholesterol | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | High-Density Lipoprotein | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Low-Density Lipoprotein | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Triglycerides | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Glucose | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Chloride | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Blood Urea Nitrogen | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Alkaline phosphatase | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Uric acid | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Albumin | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Biochemistry | Lactate dehydrogenase | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Sodium | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Uric acid | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Glucose | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Indirect Bilirubin | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Carbon dioxide | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Chloride | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Total Bilirubin | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Lactate dehydrogenase | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Blood Urea Nitrogen | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Aspartate aminotransferase | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Alanine aminotransferase | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Albumin | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Total Cholesterol | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Creatinine | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Alkaline phosphatase | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | High-Density Lipoprotein | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Potassium | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Creatine Kinase | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Low-Density Lipoprotein | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Total Protein | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Calcium | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Biochemistry | Triglycerides | 0 Participants |
Secondary
Safety Laboratory Data: Coagulation
Number of participants with treatment emergent clinically significant abnormal lab value
Time frame: 8 weeks
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Coagulation | Activated partial thromboplastin time | 0 Participants |
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Coagulation | Prothrombin time | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Coagulation | Activated partial thromboplastin time | 1 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Coagulation | Prothrombin time | 1 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Coagulation | Activated partial thromboplastin time | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Coagulation | Prothrombin time | 0 Participants |
Secondary
Safety Laboratory Data: Hematology Panel
Number of participants with treatment emergent clinically significant abnormal value \[Hemoglobin, Hematocrit, red blood cells count, white blood cell count, red cell indices, platelet count and white blood cell differential (neutrophil, lymphocyte, monocyte, eosinophil, and basophil)\].
Time frame: 8 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Hematology Panel | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Hematology Panel | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Hematology Panel | 0 Participants |
Secondary
Safety Laboratory Data: Urinalysis Panel
Number of participants with treatment emergent clinically significant abnormal value (Color, Glucose, Red blood cells, Clarity, Blood, Hyaline and other casts, pH, Bilirubin, Bacteria, Specific gravity, Leukocyte esterase, Epithelial cells, Ketones, Nitrite, Crystals, Protein, White blood cells, Yeast).
Time frame: 8 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: IRL201104 4 mg | Safety Laboratory Data: Urinalysis Panel | 0 Participants |
| Arm 2: IRL201104 8 mg | Safety Laboratory Data: Urinalysis Panel | 0 Participants |
| Arm 3: Placebo | Safety Laboratory Data: Urinalysis Panel | 0 Participants |
Secondary
Treatment Emergent Adverse Events (TEAE)
Number of participants who had a TEAE
Time frame: 8 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: IRL201104 4 mg | Treatment Emergent Adverse Events (TEAE) | 6 Participants |
| Arm 2: IRL201104 8 mg | Treatment Emergent Adverse Events (TEAE) | 7 Participants |
| Arm 3: Placebo | Treatment Emergent Adverse Events (TEAE) | 7 Participants |
Secondary
Vital Signs
Number of participants with treatment emergent clinically significant abnormal value (systolic and diastolic blood pressure, heart rate, respiratory rate, and temperature).
Time frame: 8 weeks
Population: Safety Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: IRL201104 4 mg | Vital Signs | 0 Participants |
| Arm 2: IRL201104 8 mg | Vital Signs | 0 Participants |
| Arm 3: Placebo | Vital Signs | 0 Participants |