| Primary | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16 | The EASI is a tool to measure the severity of clinical signs and the percentage of affected body surface area (BSA) in patients with atopic dermatitis (AD). The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). | The Intent-To-treat (ITT) Population included all randomized participants who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG003 | Placebo Tablets BID | Oral, twice daily morning and evening Placebo: Placebo matching tablets |
| | Units | Counts |
|---|
| Participants | - OG00058
- OG00161
- OG00259
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-55.1± 4.89
- OG001-52.2± 5.39
- OG002-61.4± 5.02
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.505 | | Mean Difference (Net) | -4.6 | Standard Error of the Mean | 6.93 | 2-Sided | 95 | -18.2 | 9.0 | | | | | Superiority | | | | | ANCOVA | | 0.812 |
|
| Secondary | Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16 | The EASI is a tool to measure the severity of clinical signs and the percentage of affected BSA in patients with AD. The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). | The ITT Population included all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | At Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID |
|
| Secondary | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16 | The IGA-AD is a measure used by physicians to determine a patient's overall severity of disease. The static version was used for measurement at a single point in time. The Investigator rated the severity of the patient's AD on a 5-point scale ranging from 0 (clear) to 4 (severe). | The ITT Population included all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | At Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID |
|
| Secondary | Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20 | The IGA-AD is a measure used by physicians to determine a patient's overall severity of disease. The static version was used for measurement at a single point in time. The Investigator rated the severity of the patient's AD on a 5-point scale ranging from 0 (clear) to 4 (severe). | The ITT Population included all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | At Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID |
|
| Secondary | Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20 | The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). | The ITT Population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Number | | Number of participants | | At Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | |
|
| Secondary | Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20 | The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). | The ITT Population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Number | | Number of participants | | At Weeks 2, 4, 8, 12, 16, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | |
|
| Secondary | Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20 | The EASI is an investigator-assessed instrument measuring the severity of clinical signs and the percentage of affected BSA in patients with AD. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). | The ITT Population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Number | | Number of participants | | At Weeks 2, 4, 8, 12, 16, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | |
|
| Secondary | Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20 | The EASI is a tool to measure the severity of clinical signs and the percentage of affected BSA in patients with AD. The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). | The ITT Population included all randomized participants who received at least 1 dose of study drug. | Posted | | Least Squares Mean | Standard Error | percent change | | Baseline and Weeks 2, 4, 8, 12, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 |
|
| Secondary | Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | The severity of itch (pruritus) due to AD was assessed using a horizontal 11-point NRS. Patients were asked to assess their "worst itching due to AD over the past 24 hours" on an NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). | The ITT Population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Least Squares Mean | Standard Error | units on a scale | | Baseline, Weeks 1, 2, 4, 8, 12, 16, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID |
|
| Secondary | Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20 | The severity of itch (pruritus) due to AD was assessed using a horizontal 11-point NRS. Patients were asked to assess their "worst itching due to AD over the past 24 hours" on an NRS anchored by the terms "no itching" (0) and "worst possible itching" (10). | The ITT Population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Number | | percentage of participants | | At Weeks 1, 2, 4, 8, 12, 16 and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | |
|
| Secondary | Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20 | The BSA assessment estimated the extent of disease or skin affected by AD and was expressed as a percentage of total BSA. BSA was determined by the Investigator or designee using the participant's hand (palm + fingers) = 1% BSA rule. | The ITT Population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Least Squares Mean | Standard Error | percentage of total body surface | | Baseline and Weeks 2, 4, 8, 12, 16, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID |
|
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20 | The DLQI is a 10-item validated questionnaire completed by the patient and used to assess the effect of skin disease on the patient's quality of life during the previous week. The 10 questions cover the following topics: symptoms; embarrassment; interference with shopping and home care, clothing choices, social and leisure activities, sports participation, work or study, close relationships, and sex; and treatment. Each question is scored from 0 to 3 ("not at all," "a little," "a lot," and "very much," respectively), giving a total score ranging from 0 to 30. A high score is indicative of a poor quality of life. | The ITT Population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Weeks 8, 16, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20 | The POEM is a 7-item, validated questionnaire completed by the patient to assess disease symptoms. Patients were asked to respond to questions on frequency of sleep loss and skin dryness, itching, flaking, cracking, bleeding, and weeping over the past week. All answers carry equal weight, with a total possible score ranging from 0 to 28. A high score is indicative of a poor quality of life. | The ITT Population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Weeks 2, 4, 8, 12, 16, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20 | The PGIS scale is a single question asking the patient how he or she would rate his or her overall AD symptoms over the past 24 hours. The 5 categories of responses are (0) "no symptoms", (1) "very mild", (2) "mild", (3) "moderate", and (4) "severe." | The ITT Population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Weeks 2, 4, 8, 12, 16, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID |
|
| Secondary | Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20 | The PGIC scale measures change in clinical status of AD. The PGIC is based on a 7-point scale, and the patient will rate the change from the start of treatment as 1 "very much improved," 2 "much improved," 3 "minimally improved," 4 "no change," 5 "minimally worse," 6 "much worse," and 7 "very much worse." | The ITT Population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Weeks 2, 4, 8, 12, 16, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 |
|
| Secondary | Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20 | The sleep disturbance NRS is a scale used by the patients to report their degree of sleep loss related to AD. Patients were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being "no sleep loss related to signs/symptoms of AD" and 10 being "I cannot sleep at all because of the signs/symptoms of AD". Higher scores indicate worse outcomes. | The ITT Population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20 | The skin pain NRS is a patient-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Overall severity of a participant's skin pain is indicated by selecting the number that best describes the worst level of skin pain in the past 24 hours. | The ITT Population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Least Squares Mean | Standard Error | score on a scale | | Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 |
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAE) | An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at screening, worsens during the study, regardless of the suspected cause of the event. | The safety population included all randomized participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | From Baseline through Week 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16 | A complete physical examination (a check of the head, eyes, ears, nose, and throat; heart; lungs; abdomen; skin; cervical and axillary lymph nodes; and neurological and musculoskeletal systems) was performed at screening (Visit 1) and Weeks 16. | The safety population included all randomized participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | At Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Body Temperature at Weeks 16 and 20 | A complete physical examination that included body temperature measurement was performed at screening (Visit 1) and Weeks 16 and 20. | The safety population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Mean | Standard Deviation | Degree Celsius | | Baseline and Weeks 16 and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Respiration Rate at Weeks 16 and 20 | A complete physical examination that included respiration rate measurement was performed at screening (Visit 1) and Weeks 16 and 20. | The safety population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Mean | Standard Deviation | Breaths per minute | | Baseline and Weeks 16 and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Heart Rate at Weeks 16 and 20 | A complete physical examination that included heart rate measurement was performed at screening (Visit 1) and Weeks 16 and 20. | The safety population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Mean | Standard Deviation | Beats per minute | | Baseline and Weeks 16 and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20 | A complete physical examination that included systolic and diastolic blood pressure measurements was performed at screening (Visit 1) and Weeks 16 and 20. | The safety population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Mean | Standard Deviation | mmHg | | Baseline and Weeks 16 and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20 | A complete physical examination that included BMI measurements was performed at screening (Visit 1) and Weeks 16 and 20. | The safety population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Mean | Standard Deviation | kg/m^2 | | Baseline and Weeks 16 and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16 | Electrocardiograms were assessed by the investigators based on automatically generated parameters. | The safety population included all randomized participants who received at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | At Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | picogram | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | Femtoliters | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hematology Parameter: Hematocrit at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | Liter per liter | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hematology Parameter: Hemoglobin at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | cells*10^9 per liter | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | |
|
| Secondary | Change From Baseline in Hematology Parameter: Platelets at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | cells*10^9 per liter | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hematology Parameter: Reticulocytes at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | percentage | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | percentage of basophils in leukocytes | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | percentage of eosinophils in leukocytes | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | percentage of lymphocytes in leukocytes | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | percentage of monocytes in leukocytes | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16 | Laboratory parameters including hematology was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | percentage of neutrophils in leukocytes | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16 | Laboratory parameters including chemistry was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | Units per liter | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID |
|
| Secondary | Change From Baseline in Chemistry Parameter: Albumin at Week 16 | Laboratory parameters including chemistry was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16 | Laboratory parameters including chemistry was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | Micromoles per liter | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16 | Laboratory parameters including chemistry was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Chemistry Parameter: Phosphate at Week 16 | Laboratory parameters including chemistry was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Mean | Standard Deviation | Millimoles per liter | | Baseline and Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16 | Laboratory parameters including chemistry was evaluated at baseline and at Week 16. | The safety population included all randomized participants who received at least 1 dose of study drug. Here "Overall Number of Participants Analyzed" represents the number of participants analyzed in each treatment arm at the given time point. | Posted | | Count of Participants | | Participants | | At Week 16 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG002 | Orismilast Modified Release Tablets 40 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20 | The HADS is a patient reported outcome, comprises of 7 questions for anxiety and 7 questions for depression, with each answer graded from 0 to 3 with a higher score indicating a worse condition. For each group of questions, scores of 7 or less indicate cases without anxiety or depression, whereas scores of 8 to 10, 11 to 14, and 15 to 21 indicate mild, moderate, and severe cases, respectively. | The safety population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Weeks 2, 4, 8, 12, 16, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | | OG001 | Orismilast Modified Release Tablets 30 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: |
|
| Secondary | Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS, Investigator-administered version, was designed to provide a prospective, standardized measure of suicidality. C-SSRS is administered in the form of a clinical interview. The C-SSRS categories have been re-ordered from the actual scale to facilitate the definitions of the endpoints, and to enable clarity in the presentation of the results: Category 1 - Wish to be Dead, Category 2 - Non-specific Active Suicidal Thoughts, Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Category 5 - Active Suicidal Ideation with Specific Plan and Intent, Category 6 - Preparatory Acts or Behavior, Category 7 - Aborted Attempt, Category 8 - Interrupted Attempt, Category 9 - Actual Attempt (non-fatal), Category 10 - Completed Suicide. | The safety population included all randomized participants who received at least 1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm. | Posted | | Count of Participants | | Participants | | At Weeks 2, 4, 8, 12, 16, and 20 | | | | ID | Title | Description |
|---|
| OG000 | Orismilast Modified Release Tablets 20 mg BID | Oral, twice daily morning and evening Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PD4 subtypes linked to inflammation. Other Names: | |
|