Plaque PsoriasisPhase 2CLEAR-PSNCT03358290
Study to Evaluate the Safety and Efficacy of JTE-051 in Subjects With Moderate to Severe Plaque Psoriasis
A Phase 2 study testing JTE-051 in people with Plaque Psoriasis and Skin Diseases, run by Shionogi Inc. at 16 sites in 2 countries.
Trial summary
Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051 administered for 12 weeks in subjects with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Plaque Psoriasis, Skin Diseases
- What is being tested?
- JTE-051
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 10 Nov 2017to 29 Oct 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with moderate to severe plaque psoriasis at least 6 months prior to Visit 1
- Plaque-type psoriasis covering ≥10% of body surface area (BSA) at Visit 1 and Visit 2;
- Psoriasis Area and Severity Index (PASI) score ≥12 at Visit 1 and Visit 2;
- Static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2;
- Body Mass Index (BMI) ≤40 at Visit 1.
Who cannot join
- Medical history of treatment failure to any systemic agents for plaque psoriasis;
- Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions at (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at Visit 1;
- Presence or history of any itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin (e.g., drug induced pruritus, significant other systemic diseases with itch) within 12 months prior to Visit 1;
- History of a clinically-significant infection (e.g., that required oral antimicrobial therapy) within 8 weeks prior to Visit 2;
- History of infections requiring hospitalization or parenteral antibiotic, antiviral, antifungal or antiparasitic therapy within 6 months prior to Visit 2 and no history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis);
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States12 sites
Atlanta Dermatology Vein and Research Center LLC
Alpharetta, Georgia, 30022
Radiant Research, Inc.
Anderson, South Carolina, 29621
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Dermatology Treatment and Research Center
Dallas, Texas, 75230
Clinical Research Advantage, Inc.
Evansville, Indiana, 47714
Forest Hills Dermatology Group
Forest Hills, New York, 11375
First OC Dermatology
Fountain Valley, California, 92708
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538
Advanced Clinical Research - Dermatology Center of Canyon County
Nampa, Idaho, 83651
Kansas City Dermatology P.A.
Overland Park, Kansas, 66215-2309
Advanced Medical Research, PC
Sandy Springs, Georgia, 30328
University of South Florida - Hospital
Tampa, Florida, 33612
Canada4 sites
Mediprobe Research Inc.
London, Ontario, N5X 2P1
Lynderm Research Inc.
Markham, Ontario, L3P 1X2
David Gratton's Private Practice
Montreal, Quebec, H3H 1V4
Karma Clinical Trials
St. John's, Newfoundland and Labrador, A1A 4Y3
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of JTE-051 Administered for 12 Weeks in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR-PS)
Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051 administered for 12 weeks in subjects with moderate to severe plaque psoriasis.
- Conditions
- Plaque Psoriasis, Skin Diseases
- Being tested
- JTE-051, Placebo
- Keywords
- JTE-051, Psoriasis
- Medical subject headings
- Skin Diseases, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTE-051Drug
Active drug tablets containing JTE-051
PlaceboDrug
Placebo tablets identical in appearance to the active drug tablets
| Study group | Role | What they receive |
|---|---|---|
| JTE-051 Dose 1 | Experimental | One dose of study drug by mouth daily for 12 weeks Receives: Drug: JTE-051 |
| JTE-051 Dose 2 | Experimental | One dose of study drug by mouth daily for 12 weeks Receives: Drug: JTE-051 |
| JTE-051 Dose 3 | Experimental | One dose of study drug by mouth daily for 12 weeks Receives: Drug: JTE-051 |
| JTE-051 Dose 4 | Experimental | One dose of study drug by mouth daily for 12 weeks Receives: Drug: JTE-051 |
| Placebo | Experimental | One dose of study drug by mouth daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) by End-of-treatment (EOT).
The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
The PASI-75 response rate is defined as at least 75 percent (%) reduction in PASI score relative to Baseline.
Measured: Up to 12 Weeks
Secondary outcomes (13)
Percent Change From Baseline in PASI Score
The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
Percent change was calculated by taking the Week 12 PASI score and subtracting the baseline PASI, and dividing by the baseline PASI, then multiplying by 100 to get the percent change from baseline.
Measured: Week 12
Proportion of Subjects Achieving PASI-50 (50% Improvement From Baseline in PASI)
The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
The PASI-50 response rate is defined as at least 50 percent (%) reduction in PASI score relative to Baseline.
Measured: Week 12
Proportion of Subjects Achieving PASI-90 (90% Improvement From Baseline in PASI)
The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
The PASI-90 response rate is defined as at least 90 percent (%) reduction in PASI score relative to Baseline.
Measured: Week 12
Proportion of Subjects Achieving PASI-100 (100% Improvement From Baseline in PASI)
The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks).
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.
The PASI-100 response rate is defined as 100 percent (%) reduction in PASI score relative to Baseline.
Measured: Week 12
Proportion of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1
The sPGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the redness, thickness and scaling across all psoriatic lesions. Average redness, thickness and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score is calculated as average of the 3 severity (redness, thickness and scaling) scores and rounded to the nearest whole number score to determine the sPGA score (0=cleared; 1=minimal; 2=mild; 3=moderate; and 4=severe).
For this outcome measure, a score of 0 means no symptoms of psoriasis and a score of 1 means minimal symptoms of psoriasis.
Measured: Week 12
Change From Baseline in Static Physician's Global Assessment (sPGA) Score
The sPGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the redness, thickness and scaling across all psoriatic lesions. Average redness, thickness and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score is calculated as average of the 3 severity (redness, thickness and scaling) scores and rounded to the nearest whole number score to determine the sPGA score (0=cleared; 1=minimal; 2=mild; 3=moderate; and 4=severe).
Change from baseline to Week 12 in sPGA was calculated by taking the Week 12 sPGA and subtracting the baseline sPGA.
Measured: Week 12
Percent Change From Baseline in Psoriasis Body Surface Area (BSA)
The total body surface area (BSA) affected by plaque-type psoriasis was obtained from the percentages of areas affected, including head, trunk, upper limbs and lower limbs. Each reported percentage was multiplied by its respective body region corresponding factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) and the resulting 4 values were added up to obtain the total psoriasis BSA (Range: 0 to 100).
BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region surface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.
Percent change from baseline to Week 12 in BSA was calculated by taking the Week 12 BSA and subtracting the baseline BSA, then dividing by the baseline BSA and multiplying by 100.
A negative change from baseline at Week 12 indicates a reduction in the Psoriasis BSA compared to the baseline.
Measured: Week 12
Change From Baseline in the Skindex-16 Overall Score
Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional \& functional; their respective scores are expressed in a linear scale from 0 to 100. Overall scale score is an average of 16 items expressed in a linear scale from 0 to 100.
Change from baseline to Week 12 in the Skindex-16 Overall Score was calculated by taking the Week 12 Skindex-16 Overall Score and subtracting the baseline Skindex-16 Overall Score.
A negative change from baseline at Week 12 indicates an improvement in the subject's condition compared to the baseline.
Measured: Week 12
Change From Baseline in the Skindex-16 Symptoms Scale Score
Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional \& functional; their respective scores are expressed in a linear scale from 0 to 100. Symptoms scale score is an average of items 1 to 4 expressed in a linear scale from 0 to 100.
Change from baseline to Week 12 in the Skindex-16 Symptoms Scale Score was calculated by taking the Week 12 Skindex-16 Symptoms Scale Score and subtracting the baseline Skindex-16 Symptoms Scale Score.
A negative change from baseline at Week 12 indicates an improvement in the subject's condition compared to the baseline.
Measured: Week 12
Change From Baseline in the Skindex-16 Emotions Scale Score
Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional \& functional; their respective scores are expressed in a linear scale from 0 to 100. Emotions scale score is an average of items 5 to 11 expressed in a linear scale from 0 to 100.
Change from baseline to Week 12 in the Skindex-16 Emotions Scale Score was calculated by taking the Week 12 Skindex-16 Emotions Scale Score and subtracting the baseline Skindex-16 Emotions Scale Score.
A negative change from baseline at Week 12 indicates an improvement in the subject's condition compared to the baseline.
Measured: Week 12
Change From Baseline in the Skindex-16 Functioning Scale Score
Skindex-16 questionnaire contains 16 questions related to quality of life in subjects with skin disease. It consists of a short 16-item assessment completed by the subject, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional \& functional; their respective scores are expressed in a linear scale from 0 to 100. Functioning scale score is an average of items 12 to 16 expressed in a linear scale from 0 to 100.
Change from baseline to Week 12 in the Skindex-16 Functioning Scale Score was calculated by taking the Week 12 Skindex-16 Functioning Scale Score and subtracting the baseline Skindex-16 Functioning Scale Score. A negative change from baseline at Week 12 indicates an improvement in the subject's condition compared to the baseline.
Measured: Week 12
Number of Subjects With Treatment-emergent Adverse Events
Subjects in the Safety Population (13, subjects who were randomly assigned to treatment and who received at least one dose of study drug). The study was terminated early as per the Sponsor decision. All randomized subjects were included in the Safety Population.
Measured: Up to 16 Weeks
JTE-051 Trough Plasma Concentrations
Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentrations of JTE-051 in the subjects randomized to JTE-051 treatment groups.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2017
- Study start10 Nov 2017
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Why it stopped: Difficulty faced with enrollment in the study
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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358290
- Sponsor's protocol ID
- AE051-G-16-007
- Acronym
- CLEAR-PS
- Status last verified
- Jul 2021
- First submitted
- 17 Nov 2017
- Last updated
- 6 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of JTE-051 Administered for 12 Weeks in Subjects With Moderate to Severe Plaque Psoriasis (CLEAR-PS)
- ClinicalTrials.gov ID
- NCT03358290
- Acronym / sponsor ID
- CLEAR-PS / AE051-G-16-007
- Conditions
- Plaque Psoriasis, Skin Diseases
- Keywords
- JTE-051, Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty faced with enrollment in the study
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 30 Nov 2017 (actual)
- Results
- Posted 6 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the efficacy, safety, tolerability and pharmacokinetics of JTE-051 administered for 12 weeks in subjects with moderate to severe plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| JTE-051 Dose 1 | Experimental | Drug: JTE-051One dose of study drug by mouth daily for 12 weeks |
| JTE-051 Dose 2 | Experimental | Drug: JTE-051One dose of study drug by mouth daily for 12 weeks |
| JTE-051 Dose 3 | Experimental | Drug: JTE-051One dose of study drug by mouth daily for 12 weeks |
| JTE-051 Dose 4 | Experimental | Drug: JTE-051One dose of study drug by mouth daily for 12 weeks |
| Placebo | Experimental | Drug: PlaceboOne dose of study drug by mouth daily for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with moderate to severe plaque psoriasis at least 6 months prior to Visit 1
- Plaque-type psoriasis covering ≥10% of body surface area (BSA) at Visit 1 and Visit 2;
- Psoriasis Area and Severity Index (PASI) score ≥12 at Visit 1 and Visit 2;
- Static Physician's Global Assessment (sPGA) score ≥3 at Visit 1 and Visit 2;
- Body Mass Index (BMI) ≤40 at Visit 1.
Key exclusion criteria (5 listed)
- Medical history of treatment failure to any systemic agents for plaque psoriasis;
- Presence of erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis or other skin conditions at (e.g., clinically-significant eczema or severe acne) that could interfere with study evaluations at Visit 1;
- Presence or history of any itch due to underlying conditions other than plaque psoriasis which cause or influence pruritus of the skin (e.g., drug induced pruritus, significant other systemic diseases with itch) within 12 months prior to Visit 1;
- History of a clinically-significant infection (e.g., that required oral antimicrobial therapy) within 8 weeks prior to Visit 2;
- History of infections requiring hospitalization or parenteral antibiotic, antiviral, antifungal or antiparasitic therapy within 6 months prior to Visit 2 and no history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis);
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 |
|---|---|---|
| JTE-051Active drug tablets containing JTE-051 | Drug | JTE-051 Dose 1, JTE-051 Dose 2, JTE-051 Dose 3, JTE-051 Dose 4 |
| PlaceboPlacebo tablets identical in appearance to the active drug tablets | Drug | Placebo |
Primary outcome
Proportion of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) by End-of-treatment (EOT).
Time frame: Up to 12 Weeks
The psoriasis area and severity index (PASI) combines the assessment of the severity of lesions (scaling, redness and plaque thickness) and the area affected into a single score in the range of 0.0 (no disease) to 72.0 (maximal disease). The body is divided into four sections: (1) Head and neck; (2) Upper limbs; (3) Trunk (including axillae and groin); and (4) Lower limbs (including buttocks). The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. The PASI-75 response rate is defined as at least 75 percent (%) reduction in PASI score relative to Baseline.
13 secondary outcomes
Percent Change From Baseline in PASI Score
Time frame: Week 12
Proportion of Subjects Achieving PASI-50 (50% Improvement From Baseline in PASI)
Time frame: Week 12
Proportion of Subjects Achieving PASI-90 (90% Improvement From Baseline in PASI)
Time frame: Week 12
Proportion of Subjects Achieving PASI-100 (100% Improvement From Baseline in PASI)
Time frame: Week 12
Proportion of Subjects Who Achieved Static Physician's Global Assessment (sPGA) Score of 0 or 1
Time frame: Week 12
Change From Baseline in Static Physician's Global Assessment (sPGA) Score
Time frame: Week 12
Percent Change From Baseline in Psoriasis Body Surface Area (BSA)
Time frame: Week 12
Change From Baseline in the Skindex-16 Overall Score
Time frame: Week 12
Change From Baseline in the Skindex-16 Symptoms Scale Score
Time frame: Week 12
Change From Baseline in the Skindex-16 Emotions Scale Score
Time frame: Week 12
Change From Baseline in the Skindex-16 Functioning Scale Score
Time frame: Week 12
Number of Subjects With Treatment-emergent Adverse Events
Time frame: Up to 16 Weeks
JTE-051 Trough Plasma Concentrations
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JTE-051 in people with Plaque Psoriasis and Skin Diseases, run by Shionogi Inc. at 16 sites in 2 countries.
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 5 inclusion and 5 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 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada. 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. 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 Aug 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?
Proportion of Subjects Achieving a Minimum 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI-75) by End-of-treatment (EOT). (time frame: Up to 12 Weeks). 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 Aug 2021.