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safety reason
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The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of AGN-242428 in adult participants with moderate to severe plaque-type psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
|
| AGN-242428 Higher Dose | Experimental | AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
|
| AGN-242428 Medium Dose | Experimental | AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
|
| AGN-242428 Lower Dose | Experimental | AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-242428 | Drug | AGN-242428 administered as an oral capsule(s) once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Reduction (Improvement) in Psoriasis Area and Severity Index (PASI) Score of ≥ 75% From Baseline to Week 16 | The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area. | Baseline (Day 1) to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving ≥ 2-point Reduction (Improvement) in Physician's Global Assessment (PGA) Score at Week 16 | The investigator evaluated the participant's overall severity of psoriasis using the PGA 5-point scale (0 to 4) where 0=Clear and 4=Severe. | Baseline (Day 1) to Week 16 |
| Percentage of Participants Achieving a Clear (0) or Almost Clear (1) Score in PGA at Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christy Harutunian | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | 35205 | United States | ||
| Radiant Tucson |
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance. | View source |
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As the study was terminated, no participants completed the planned dosing schedule of 16 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
| FG001 | AGN-242428 Higher Dose | AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2017 | Mar 10, 2021 |
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| Placebo | Drug | Placebo administered as an oral capsule(s) once daily. |
|
The investigator evaluated the participant's overall severity of psoriasis using the PGA 5-point scale (0 to 4) where 0=Clear to 4=Severe. |
| Week 16 |
| Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 50% From Baseline to Week 16 | The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area. | Baseline (Day 1) to Week 16 |
| Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 90% From Baseline to Week 16 | The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area. | Baseline (Day 1) to Week 16 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date of the first dose of study drug. | First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose |
| Number of Participants With TEAEs Leading to Discontinuation | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date of the first dose of study drug. | First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose |
| Number of Participants With TEAEs Considered Related to the Study Treatment as Per Investigator | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date of the first dose of study drug. The TEAEs related to the study drug, as assessed by Investigator are reported. | First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose |
| Plasma Concentration of AGN-242428 | Single sample predose at Week 4 and 8 Visits, single sample 1-2 hours postdose at Weeks 6 and 10 Visits |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Johnson Dermatology | Fort Smith | Arkansas | 72916 | United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| University Clinical Trials | San Diego | California | 92123 | United States |
| Horizons Clinical Research Center | Denver | Colorado | 80220 | United States |
| Belleair Research Center | Pinellas Park | Florida | 33781 | United States |
| Dawes Fretzin Dermatology Group | Indianapolis | Indiana | 46256 | United States |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | 46168 | United States |
| South Bend Clinic | South Bend | Indiana | 46617 | United States |
| Kansas City Dermatology | Overland Park | Kansas | 66215 | United States |
| Somerset Skin Centre | Troy | Michigan | 48084 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| Arlington Research Center, Inc | Arlington | Texas | 76011 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| FG002 | AGN-242428 Medium Dose | AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
| FG003 | AGN-242428 Lower Dose | AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks. |
| Modified Intent-to-Treat Population |
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| Safety Population: Received Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
|
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Modified Intent-to-Treat (mITT) population included all randomized participants with at least 1 postbaseline Psoriasis Area and Severity Index (PASI) assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
| BG001 | AGN-242428 Higher Dose | AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
| BG002 | AGN-242428 Medium Dose | AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
| BG003 | AGN-242428 Lower Dose | AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Psoriasis Area and Severity Index (PASI) Score at Baseline | The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area. | Mean | Standard Deviation | score on a scale |
|
| 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 | Percentage of Participants Achieving a Reduction (Improvement) in Psoriasis Area and Severity Index (PASI) Score of ≥ 75% From Baseline to Week 16 | The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area. | No data was collected for this Outcome Measure because the study was terminated and no participants reached the Week 16 timepoint. | Posted | Baseline (Day 1) to Week 16 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ≥ 2-point Reduction (Improvement) in Physician's Global Assessment (PGA) Score at Week 16 | The investigator evaluated the participant's overall severity of psoriasis using the PGA 5-point scale (0 to 4) where 0=Clear and 4=Severe. | No data was collected for this Outcome Measure because the study was terminated and no participants reached the Week 16 timepoint. | Posted | Baseline (Day 1) to Week 16 |
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Clear (0) or Almost Clear (1) Score in PGA at Week 16 | The investigator evaluated the participant's overall severity of psoriasis using the PGA 5-point scale (0 to 4) where 0=Clear to 4=Severe. | No data was collected for this Outcome Measure because the study was terminated and no participants reached the Week 16 timepoint. | Posted | Week 16 |
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 50% From Baseline to Week 16 | The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area. | No data was collected for this Outcome Measure because the study was terminated and no participants reached the Week 16 timepoint. | Posted | Baseline (Day 1) to Week 16 |
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 90% From Baseline to Week 16 | The PASI score ranges from 0-72 (with a higher score indicating greater severity of psoriasis), based on a combination of the severity (erythema, induration, and desquamation) of psoriasis and percentage of affected area. | No data was collected for this Outcome Measure because the study was terminated and no participants reached the Week 16 primary timepoint. | Posted | Baseline (Day 1) to Week 16 |
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date of the first dose of study drug. | Safety population included all participants who received at least 1 administration of study treatment. | Posted | Count of Participants | Participants | First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With TEAEs Leading to Discontinuation | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date of the first dose of study drug. | Safety population included all participants who received at least 1 administration of study treatment. | Posted | Count of Participants | Participants | First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With TEAEs Considered Related to the Study Treatment as Per Investigator | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date of the first dose of study drug. The TEAEs related to the study drug, as assessed by Investigator are reported. | Safety population included all participants who received at least 1 administration of study treatment. | Posted | Count of Participants | Participants | First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose |
| |||||||||||||||||||||||||||
| Secondary | Plasma Concentration of AGN-242428 | Pharmacokinetic (PK) population included all participants who received AGN-242428 and had available plasma concentration data at the given timepoint. No PK data was collected at Week 12 for participants who received AGN-242428 or Week 16 as the study was terminated. | Posted | Mean | Standard Deviation | ng/mL | Single sample predose at Week 4 and 8 Visits, single sample 1-2 hours postdose at Weeks 6 and 10 Visits |
|
|
First dose of study drug to the last dose of study drug (up to Week 12) plus approximately 30 days past last dose
Safety population included all participants who received at least 1 administration of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. | 0 | 7 | 0 | 7 | 5 | 7 |
| EG001 | AGN-242428 Higher Dose | AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | AGN-242428 Medium Dose | AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | AGN-242428 Lower Dose | AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks. | 0 | 4 | 0 | 4 | 1 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA version 20.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA version 20.1 | Systematic Assessment |
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| Mycobacterium tuberculosis complex test positive | Investigations | MedDRA version 20.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA version 20.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA version 20.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA version 20.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 20.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 20.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 20.1 | Systematic Assessment |
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| Glycosuria | Renal and urinary disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2018 | Mar 10, 2021 | SAP_001.pdf |
| Male |
|
| Asian |
|
| Not Hispanic or Latino |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
| OG003 | AGN-242428 Lower Dose | AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks. |
|
|
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks.
| OG003 | AGN-242428 Lower Dose | AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks. |
|
|
AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
| OG003 | AGN-242428 Lower Dose | AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks. |
|
|
|