Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase 2a study to be run in 2-3 countries in European Union involving 5-6 sites. It will enroll approximately 80 patients to ensure 40 randomized with active rheumatoid arthritis. The treatment period is 2 weeks and total study duration per patient is approximately 1 month. The study drugs are AZD9567 40 mg (an oral SGRM) and the comparator is prednisolone 20mg. The primary endpoint is DAS28 including evaluation of 28 joints and C-reactive protein. Safety parameters will also be evaluated and a biomarker program is included for future research.
This randomized double blind with double dummy technique phase 2a study will be run in 2-3 EU countries, most likely Sweden, Denmark and The Netherlands involving 5-6 sites. It is estimated that 80-100 patients have to be enrolled to ensure the randomization target of 40. The study population is patients with rheumatoid arthritis on stable treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs) with an active flare. It is a two-arm parallel study and the randomization ratio is 1:1 to the two weeks of once daily treatment of 40 mg of AZD9567 and 20 mg prednisolone.
The primary objective is to assess the efficacy of AZD9567 40 mg, compared to prednisolone 20 mg in patients with active rheumatoid arthritis in spite of stable treatment with conventional and/or s.c/i.v. biological DMARDs and the primary variable is change from baseline in 28 joint Disease Activity Score using CRP (DAS28 - CRP). As secondary variables swollen and tenderness of 66-68 joints and safety variables are also included. For exploratively purposes there is also a biomarker program, collecting blood samples for future research.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD9567 | Experimental | oral suspension of 40 mg AZD9567 once daily (OD) for two weeks |
|
| Prednisolone | Active Comparator | oral OD treatment of 20 mg prednisolone administered as capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD9567 | Drug | oral OD SGRM administered as suspension |
| |
| Prednisolone |
| Measure | Description | Time Frame |
|---|---|---|
| Least Square (LS) Mean Change From Baseline in 28 Joint Disease Activity Score Using C-Reactive Protein (DAS28-CRP) at Day 15 | The DAS28-CRP is a measure of disease activity in RA. The score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment (PGA) of health (ranging from very well to very poor). The DAS28-CRP was derived as follows: 0.56 x √[tender joint count 28 (TJC28)] + 0.28 x √[swollen joint count 28 (SJC28)] + 0.014 x global health (GH) + 0.36 x Ln(CRP+1) + 0.96 to produce the overall DAS28-CRP score on a scale ranged from 0-10 with higher score indicating worse RA symptoms. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | Baseline (Day 1) and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Responses | The ACR20, ACR50 or ACR70 was achieved if there was at least a 20%, 50% or 70% improvement from baseline in swollen joint count 66 (SJC66) and tender joint count 68 (TJC68) and 3 or more of the 5 following assessments: participant's assessment of pain, GH, physician's global assessment of disease activity, participant's assessment of physical function and CRP. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jacob M Van Laar, Professor | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Enschede | 7512 KZ | Netherlands | |||
| Research Site |
Not provided
| Label | URL |
|---|---|
| Redacted Protocol | View source |
| SAP | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 21 participants were randomized in a 1:1 ratio to take either AZD9567 or prednisolone in a 2-week double-blind, double-dummy treatment period.
This was a Phase 2a study conducted in participants with active rheumatoid arthritis (RA) in spite of stable treatment with conventional disease-modifying anti-rheumatic drugs at 5 investigational sites across Sweden and The Netherlands between 18 January 2018 and 12 November 2019.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AZD9567 | Participants received AZD9567 40 milligram (mg) oral suspension and placebo capsules matching with prednisolone, orally once daily, for 2 weeks. |
| FG001 | Prednisolone | Participants received prednisolone 20 mg oral capsules and placebo oral suspension matching with AZD9567, once daily for 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Full analysis set (FAS) included all participants who were randomized and received at least 1 dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZD9567 | Participants received AZD9567 40 mg oral suspension and placebo capsules matching with prednisolone, orally once daily, for 2 weeks. |
| BG001 | Prednisolone | Participants received prednisolone 20 mg oral capsules and placebo oral suspension matching with AZD9567, once daily for 2 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Least Square (LS) Mean Change From Baseline in 28 Joint Disease Activity Score Using C-Reactive Protein (DAS28-CRP) at Day 15 | The DAS28-CRP is a measure of disease activity in RA. The score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment (PGA) of health (ranging from very well to very poor). The DAS28-CRP was derived as follows: 0.56 x √[tender joint count 28 (TJC28)] + 0.28 x √[swollen joint count 28 (SJC28)] + 0.014 x global health (GH) + 0.36 x Ln(CRP+1) + 0.96 to produce the overall DAS28-CRP score on a scale ranged from 0-10 with higher score indicating worse RA symptoms. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | The FAS included all participants who were randomized and received at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and Day 15 |
|
From first administration of study treatment (Day 1) up to 2 weeks after last administration of study treatment, approximately 28 days.
The Safety analysis set included all participants who were randomized and received at least 1 dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD9567 | Participants received AZD9567 40 mg oral suspension and placebo capsules matching with prednisolone, orally once daily, for 2 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression suicidal | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Lead | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2019 | Sep 11, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2019 | Sep 11, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000712985 | AZD9567 |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
Randomized, double blind, parallell arm study with two weeks treatment of AZD9567 or prednisolone
Not provided
Not provided
Double dummy technique
| Drug |
oral capsules of 20 mg prednisolone administered OD for two weeks |
|
| Day 15 |
| LS Mean Change From Baseline in SJC66 Score at Day 15 | A total of 66 joints (33 left, 33 right) were evaluated for swelling. The swollen joint count represents the number of joints in which there was synovial fluid and or soft tissue swelling, but not if bony overgrowth was found. A swollen joint was scored as 0 (absent) and 1 (present) for each joint. The SJC66 was calculated as sum of swollen joints with present status on electronic case report form (eCRF). The swollen joint count ranged from 0-66 with higher score indicating disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | Baseline and Day 15 |
| LS Mean Change From Baseline in TJC68 Score at Day 15 | A total of 68 joints (34 left, 34 right) were evaluated for tenderness. The tender joint count represents the number of joints in which pain was reported. A tender joint was scored as 0 (absent) and 1 (present) for each joint. The TJC68 was calculated as sum of tender joints with present status on eCRF. The tender joint count ranged from 0-68 with higher score indicating disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | Baseline and Day 15 |
| LS Mean Change From Baseline in TJC28 Score at Day 15 | TJC28 was evaluated as one of the components that comprised the DAS28-score. A total of 28 joints (14 left, 14 right) were evaluated for tenderness as obtained from the joint count right or left eCRF. The tender joint count represents the number of joints in which pain was reported. A tender joint was scored as 0 (absent) and 1 (present) for each joint. The TJC28 was calculated as sum of tender joints with present status on eCRF. The tender joint count ranged from 0-28 with higher score indicating disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | Baseline and Day 15 |
| LS Mean Change From Baseline in SJC28 Score at Day 15 | SJC28 was evaluated as one of the components that comprised the DAS28-score. A total of 28 joints (14 left, 14 right) were evaluated for swelling as obtained from the joint count right or left eCRF. The swollen joint count represents the number of joints in which there was synovial fluid and or soft tissue swelling, but not if bony overgrowth was found. A swollen joint was scored as 0 (absent) and 1 (present) for each joint. The SJC28 was calculated as sum of swollen joints with present status on eCRF. The swollen joint count ranged from 0-28 with higher score indicating disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | Baseline and Day 15 |
| LS Mean Change From Baseline in GH Score at Day 15 | GH was evaluated as one of the components that comprised the DAS28-score. Participant's GH was measured using PGA of disease activity by means of the visual analogue scale (VAS). The PGA VAS consists of a 100 millimeter (mm) long scale ranging from 0 (very well) to 100 (very poor). Higher score indicated greater disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | Baseline and Day 15 |
| LS Mean Change From Baseline in CRP at Day 15 | CRP was evaluated as one of the components that comprised the DAS28-score. The CRP was collected at the local laboratory during screening and central laboratory on Days 1, 8, 15 and 28. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | Baseline and Day 15 |
| LS Mean Change From Baseline in Participant's Assessment of Pain Score at Day 15 | Participant's assessment of pain score was evaluated as one of the components that comprised the ACR. Participant's assessment of pain score was assessed from the amount of pain due to RA on a VAS ranging from 0 (no pain) to 100 (extreme pain). Higher score indicated greater disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | Baseline and Day 15 |
| LS Mean Change From Baseline in Physician's Global Assessment of Disease Activity Score at Day 15 | Physician's global assessment of disease activity score was evaluated as one of the components that comprised the ACR. The physician's global assessment of disease activity was measured on a VAS ranging from 0 (very well) to 100 (very poor). Higher score indicated greater disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | Baseline and Day 15 |
| LS Mean Change From Baseline in Participant's Assessment of Physical Function Score at Day 15 | Participant's assessment of physical function score was evaluated as one of the components that comprised the ACR. The participant's assessment of physical function across 8 functional areas was measured by health assessment questionnaire. The total score ranging from 0 (no difficulty) to 24 (inability to perform tasks). Higher score indicated greater disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | Baseline and Day 15 |
| Area Under the Plasma Concentration-Time Curve Until the Last Quantifiable Concentration (AUClast) of AZD9567 | The AUClast was determined using non-compartmental method and calculated using the linear trapezoidal rule when concentrations were increased and the logarithmic trapezoidal rule when concentrations were decreased. | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15. |
| Area Under the Concentration-Time Curve From Time Zero to 6 Hours After Dose (AUC0-6) of AZD9567 | The AUC0-6 was determined using non-compartmental method and calculated using the linear trapezoidal rule when concentrations were increased and the logarithmic trapezoidal rule when concentrations were decreased. | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15. |
| Maximum Observed Plasma Concentration (Cmax) of AZD9567 | The Cmax of AZD9567 was determined using non-compartmental method. | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15. |
| Time to Reach Maximum Plasma Concentration (Tmax) of AZD9567 | The tmax of AZD9567 was determined using non-compartmental method. | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15. |
| Last Plasma Concentration Measured Before the Last Dose (Ctrough) of AZD9567 | The Ctrough of AZD9567 was determined using non-compartmental method before the last dose on Day 15. | Predose on Day 15 |
| Maastricht |
| 6229 HX |
| Netherlands |
| Research Site | Utrecht | 3584 CX | Netherlands |
| Research Site | Gothenburg | 413 45 | Sweden |
| Research Site | Lund | 221 85 | Sweden |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| AZD9567 |
Participants received AZD9567 40 mg oral suspension and placebo capsules matching with prednisolone, orally once daily, for 2 weeks. |
| OG001 | Prednisolone | Participants received prednisolone 20 mg oral capsules and placebo oral suspension matching with AZD9567, once daily for 2 weeks. |
|
|
|
| Secondary | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Responses | The ACR20, ACR50 or ACR70 was achieved if there was at least a 20%, 50% or 70% improvement from baseline in swollen joint count 66 (SJC66) and tender joint count 68 (TJC68) and 3 or more of the 5 following assessments: participant's assessment of pain, GH, physician's global assessment of disease activity, participant's assessment of physical function and CRP. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | The FAS included all participants who were randomized and received at least 1 dose of study treatment. Participants with missing ACR assessment at Day 15 were considered as non-responders in the respective analysis. | Posted | Number | percentage of participants | Day 15 |
|
|
|
|
| Secondary | LS Mean Change From Baseline in SJC66 Score at Day 15 | A total of 66 joints (33 left, 33 right) were evaluated for swelling. The swollen joint count represents the number of joints in which there was synovial fluid and or soft tissue swelling, but not if bony overgrowth was found. A swollen joint was scored as 0 (absent) and 1 (present) for each joint. The SJC66 was calculated as sum of swollen joints with present status on electronic case report form (eCRF). The swollen joint count ranged from 0-66 with higher score indicating disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | The FAS included all participants who were randomized and received at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 15 |
|
|
|
|
| Secondary | LS Mean Change From Baseline in TJC68 Score at Day 15 | A total of 68 joints (34 left, 34 right) were evaluated for tenderness. The tender joint count represents the number of joints in which pain was reported. A tender joint was scored as 0 (absent) and 1 (present) for each joint. The TJC68 was calculated as sum of tender joints with present status on eCRF. The tender joint count ranged from 0-68 with higher score indicating disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | The FAS included all participants who were randomized and received at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 15 |
|
|
|
|
| Secondary | LS Mean Change From Baseline in TJC28 Score at Day 15 | TJC28 was evaluated as one of the components that comprised the DAS28-score. A total of 28 joints (14 left, 14 right) were evaluated for tenderness as obtained from the joint count right or left eCRF. The tender joint count represents the number of joints in which pain was reported. A tender joint was scored as 0 (absent) and 1 (present) for each joint. The TJC28 was calculated as sum of tender joints with present status on eCRF. The tender joint count ranged from 0-28 with higher score indicating disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | The FAS included all participants who were randomized and received at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 15 |
|
|
|
|
| Secondary | LS Mean Change From Baseline in SJC28 Score at Day 15 | SJC28 was evaluated as one of the components that comprised the DAS28-score. A total of 28 joints (14 left, 14 right) were evaluated for swelling as obtained from the joint count right or left eCRF. The swollen joint count represents the number of joints in which there was synovial fluid and or soft tissue swelling, but not if bony overgrowth was found. A swollen joint was scored as 0 (absent) and 1 (present) for each joint. The SJC28 was calculated as sum of swollen joints with present status on eCRF. The swollen joint count ranged from 0-28 with higher score indicating disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | The FAS included all participants who were randomized and received at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 15 |
|
|
|
|
| Secondary | LS Mean Change From Baseline in GH Score at Day 15 | GH was evaluated as one of the components that comprised the DAS28-score. Participant's GH was measured using PGA of disease activity by means of the visual analogue scale (VAS). The PGA VAS consists of a 100 millimeter (mm) long scale ranging from 0 (very well) to 100 (very poor). Higher score indicated greater disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | The FAS included all participants who were randomized and received at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 15 |
|
|
|
|
| Secondary | LS Mean Change From Baseline in CRP at Day 15 | CRP was evaluated as one of the components that comprised the DAS28-score. The CRP was collected at the local laboratory during screening and central laboratory on Days 1, 8, 15 and 28. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | The FAS included all participants who were randomized and received at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | mg per liter (L) | Baseline and Day 15 |
|
|
|
|
| Secondary | LS Mean Change From Baseline in Participant's Assessment of Pain Score at Day 15 | Participant's assessment of pain score was evaluated as one of the components that comprised the ACR. Participant's assessment of pain score was assessed from the amount of pain due to RA on a VAS ranging from 0 (no pain) to 100 (extreme pain). Higher score indicated greater disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | The FAS included all participants who were randomized and received at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 15 |
|
|
|
|
| Secondary | LS Mean Change From Baseline in Physician's Global Assessment of Disease Activity Score at Day 15 | Physician's global assessment of disease activity score was evaluated as one of the components that comprised the ACR. The physician's global assessment of disease activity was measured on a VAS ranging from 0 (very well) to 100 (very poor). Higher score indicated greater disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | The FAS included all participants who were randomized and received at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 15 |
|
|
|
|
| Secondary | LS Mean Change From Baseline in Participant's Assessment of Physical Function Score at Day 15 | Participant's assessment of physical function score was evaluated as one of the components that comprised the ACR. The participant's assessment of physical function across 8 functional areas was measured by health assessment questionnaire. The total score ranging from 0 (no difficulty) to 24 (inability to perform tasks). Higher score indicated greater disease severity. Baseline was defined as the last non-missing assessment (scheduled or unscheduled) prior to the first dose of study treatment. | The FAS included all participants who were randomized and received at least 1 dose of study treatment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 15 |
|
|
|
|
| Secondary | Area Under the Plasma Concentration-Time Curve Until the Last Quantifiable Concentration (AUClast) of AZD9567 | The AUClast was determined using non-compartmental method and calculated using the linear trapezoidal rule when concentrations were increased and the logarithmic trapezoidal rule when concentrations were decreased. | The Pharmacokinetic (PK) analysis set included all participants with at least 1 quantifiable AZD9567 concentration with a documented related dosing history. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanomole per L (h*nmol/L) | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15. |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Time Zero to 6 Hours After Dose (AUC0-6) of AZD9567 | The AUC0-6 was determined using non-compartmental method and calculated using the linear trapezoidal rule when concentrations were increased and the logarithmic trapezoidal rule when concentrations were decreased. | The PK analysis set included all participants with at least 1 quantifiable AZD9567 concentration with a documented related dosing history. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*nmol/L | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15. |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of AZD9567 | The Cmax of AZD9567 was determined using non-compartmental method. | The PK analysis set included all participants with at least 1 quantifiable AZD9567 concentration with a documented related dosing history. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15. |
|
|
|
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of AZD9567 | The tmax of AZD9567 was determined using non-compartmental method. | The PK analysis set included all participants with at least 1 quantifiable AZD9567 concentration with a documented related dosing history. | Posted | Median | Full Range | hour | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4 and 6 hour postdose on Day 15. |
|
|
|
| Secondary | Last Plasma Concentration Measured Before the Last Dose (Ctrough) of AZD9567 | The Ctrough of AZD9567 was determined using non-compartmental method before the last dose on Day 15. | The PK analysis set included all participants with at least 1 quantifiable AZD9567 concentration with a documented related dosing history. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/L | Predose on Day 15 |
|
|
|
| 0 |
| 11 |
| 1 |
| 11 |
| 10 |
| 11 |
| EG001 | Prednisolone | Participants received prednisolone 20 mg oral capsules and placebo oral suspension matching with AZD9567, once daily for 2 weeks. | 0 | 10 | 0 | 10 | 9 | 10 |
| Palpitations | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Periorbital swelling | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oral discomfort | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Skin atrophy | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
Not provided
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| ACR70 |
|
Treatment comparison ACR50: AZD9567 Vs prednisolone
| Fisher Exact |
| 0.198 |
| Other |
| Treatment comparison ACR70: AZD9567 Vs prednisolone | Fisher Exact | 0.183 | Other |