Plaque PsoriasisPhase 2NCT03339999
AGN-242428 in the Treatment of Plaque Psoriasis
A Phase 2 study testing AGN-242428 in people with Plaque Psoriasis, run by Vitae Pharmaceuticals, Inc. at 15 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- AGN-242428
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 15 sitesUnited States
- Study dates
- 15 Nov 2017to 20 Apr 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have a confirmed diagnosis of plaque psoriasis, diagnosed at least 6 months before study with a Physician's Global Assessment (PGA) score ≥ 3 at screening and baseline
- Severity of disease must be at least moderate, defined as Psoriasis Area and Severity Index (PASI) ≥ 12 and % body surface area (BSA) ≥ 10
- Participant is a candidate for phototherapy or systemic therapy for psoriasis
- Body weight of at least 55 kilograms (kg) (121 (pound) lbs)
Who cannot join
- Non-plaque forms of psoriasis (erythrodermic, guttate, pustular) or drug-induced psoriasis
- Psoriasis which has not been stable for the 4 weeks prior to screening and which is unstable at Study Day 1
- History of Gilbert's, Rotor, or Dubin-Johnson syndromes or any other disorder of bilirubin metabolism
- History of active mycobacterium tuberculosis (TB) infection or untreated or inadequately treated latent TB
- Positive QuantiFERON test for TB infection at screening
- Had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months prior to baseline
Show all 10Show fewer
- Positive drug and/or alcohol test at screening (with the exception of marijuana). Retesting in the case of a positive alcohol test is allowed at the discretion of the sponsor
- Current treatment or history of treatment with any anti-Tumor Necrosis Factor alpha (TNFα) biologic therapy within 3 months or 5 half-lives of study, and/or all other biologics within 6 months of study (Day 1)
- Efficacy failure on 2 or more biologic agents for the treatment of psoriasis when the failures occurred within 1 year of the initiation of the therapy of the first biologic agent
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin (TBL) exceeding 1.5 times the upper limit of normal (ULN) at screening.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Arlington Research Center, Inc
Arlington, Texas, 76011
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
Horizons Clinical Research Center
Denver, Colorado, 80220
Johnson Dermatology
Fort Smith, Arkansas, 72916
First OC Dermatology
Fountain Valley, California, 92708
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, 46256
Kansas City Dermatology
Overland Park, Kansas, 66215
Belleair Research Center
Pinellas Park, Florida, 33781
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
Oregon Medical Research Center
Portland, Oregon, 97223
Progressive Clinical Research
San Antonio, Texas, 78213
University Clinical Trials
San Diego, California, 92123
South Bend Clinic
South Bend, Indiana, 46617
Somerset Skin Centre
Troy, Michigan, 48084
Radiant Tucson
Tucson, Arizona, 85712
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AGN-242428 in Patients With Plaque Psoriasis
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.
- Conditions
- Plaque Psoriasis
- Being tested
- AGN-242428, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGN-242428Drug
AGN-242428 administered as an oral capsule(s) once daily.
PlaceboDrug
Placebo administered as an oral capsule(s) once daily.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. Receives: Drug: Placebo |
| AGN-242428 Higher Dose | Experimental | AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. Receives: Drug: AGN-242428 |
| AGN-242428 Medium Dose | Experimental | AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. Receives: Drug: AGN-242428 |
| AGN-242428 Lower Dose | Experimental | AGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks. Receives: Drug: AGN-242428; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) to Week 16
Secondary outcomes (8)
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.
Measured: Baseline (Day 1) to Week 16
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Single sample predose at Week 4 and 8 Visits, single sample 1-2 hours postdose at Weeks 6 and 10 Visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start15 Nov 2017
- Primary completion22 Mar 2018
- Study completion20 Apr 2018
Why it stopped: safety reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitae Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christy Harutunian, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339999
- Sponsor's protocol ID
- 1957-201-001
- Status last verified
- Mar 2021
- First submitted
- 8 Nov 2017
- Last updated
- 6 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AGN-242428 in Patients With Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT03339999
- Acronym / sponsor ID
- 1957-201-001
- Conditions
- Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: safety reason
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vitae Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo-matching AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
| AGN-242428 Higher Dose | Experimental | Drug: AGN-242428AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
| AGN-242428 Medium Dose | Experimental | Drug: AGN-242428AGN-242428 capsules, oral administration, once-daily for up to 12 weeks. |
| AGN-242428 Lower Dose | Experimental | Drug: AGN-242428, Drug: PlaceboAGN-242428 capsule and placebo-matching AGN-242428 capsule, oral administration, once-daily for up to 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who have a confirmed diagnosis of plaque psoriasis, diagnosed at least 6 months before study with a Physician's Global Assessment (PGA) score ≥ 3 at screening and baseline
- Severity of disease must be at least moderate, defined as Psoriasis Area and Severity Index (PASI) ≥ 12 and % body surface area (BSA) ≥ 10
- Participant is a candidate for phototherapy or systemic therapy for psoriasis
- Body weight of at least 55 kilograms (kg) (121 (pound) lbs)
Key exclusion criteria (10 listed)
- Non-plaque forms of psoriasis (erythrodermic, guttate, pustular) or drug-induced psoriasis
- Psoriasis which has not been stable for the 4 weeks prior to screening and which is unstable at Study Day 1
- History of Gilbert's, Rotor, or Dubin-Johnson syndromes or any other disorder of bilirubin metabolism
- History of active mycobacterium tuberculosis (TB) infection or untreated or inadequately treated latent TB
- Positive QuantiFERON test for TB infection at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGN-242428AGN-242428 administered as an oral capsule(s) once daily. | Drug | AGN-242428 Higher Dose, AGN-242428 Lower Dose, AGN-242428 Medium Dose |
| PlaceboPlacebo administered as an oral capsule(s) once daily. | Drug | AGN-242428 Lower Dose, Placebo |
Primary outcome
Percentage of Participants Achieving a Reduction (Improvement) in Psoriasis Area and Severity Index (PASI) Score of ≥ 75% From Baseline to Week 16
Time frame: Baseline (Day 1) 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.
8 secondary outcomes
Percentage of Participants Achieving ≥ 2-point Reduction (Improvement) in Physician's Global Assessment (PGA) Score at Week 16
Time frame: Baseline (Day 1) to Week 16
Percentage of Participants Achieving a Clear (0) or Almost Clear (1) Score in PGA at Week 16
Time frame: Week 16
Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 50% From Baseline to Week 16
Time frame: Baseline (Day 1) to Week 16
Percentage of Participants Achieving Reduction (Improvement) in PASI Score of ≥ 90% From Baseline to Week 16
Time frame: Baseline (Day 1) to Week 16
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Single sample predose at Week 4 and 8 Visits, single sample 1-2 hours postdose at Weeks 6 and 10 Visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christy Harutunian study director
Allergan
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AGN-242428 in people with Plaque Psoriasis, run by Vitae Pharmaceuticals, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving a Reduction (Improvement) in Psoriasis Area and Severity Index (PASI) Score of ≥ 75% From Baseline to Week 16 (time frame: Baseline (Day 1) to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.