Chronic Stable Plaque PsoriasisPhase 2NCT02949388
Efficacy and Safety of Prurisol Administered Orally for Active Moderate to Severe Chronic Plaque Psoriasis
A Phase 2 study testing 400 mg (200 mg BID) and 300 mg (150 mg BID) in people with Chronic Stable Plaque Psoriasis, run by Innovation Pharmaceuticals, Inc. at 34 sites in United States.
Trial summary
This study is designed as a randomized, double blind, parallel group, placebo-controlled trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily for twelve weeks to subjects with moderate to severe chronic plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Stable Plaque Psoriasis
- What is being tested?
- 400 mg (200 mg BID) and 300 mg (150 mg BID)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 34 sitesUnited States
- Study dates
- Nov 2016to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated written informed consent to participate in the clinical study
- Male or non-pregnant female adults at least 18 years of age at time of informed consent
- Chronic plaque-type psoriasis diagnosed for at least 6 months prior to baseline (at time of first study dose)
- Moderate to severe plaque psoriasis as defined at baseline by:
- PASI score of 12 or greater, and
- Static PGA score of moderate (3) or severe (4), and
Show all 10Show fewer
- Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater
- Candidate for systemic therapy or phototherapy
- Willing to limit ultraviolet light exposure from sunbathing, use of tanning booths, prolonged outdoor exposure, or from other UV light sources during the study.
- Willing and able to comply with scheduled visits, study assessments and l laboratory tests, and other study procedures
Who cannot join
- Positive blood test for HLA-B*5701 allele
- Currently have forms of psoriasis other than chronic plaque-type, (e.g., guttate, erythrodermic, exfoliative, palmoplantar, pustular), with the exception of nail psoriasis
- Evidence of drug-induced psoriasis, e.g., a new onset or current exacerbation of psoriasis from beta-blockers, calcium channel inhibitors, antimalarial drugs or lithium
- Psoriasis flare or rebound within 4 weeks prior to Screening
- Active inflammatory diseases other than psoriasis that might confound the evaluation of study treatment on signs and symptoms of psoriasis.
- . Any of the following prohibited treatments that do not meet the specified minimum washout period:
Show all 39Show fewer
- Biologic immunomodulating treatments of brodalumab or ustekinumab within 24 weeks prior to start of study treatment
- Biologic immunomodulating treatments such as adalimumab, etanercept, infliximab, ixekizumab, secukinumab or certolizumab pegol within 12 weeks prior to start of study treatment
- Systemic immunomodulating treatments other than biologics within 4 weeks prior to start of study treatment, e.g., oral corticosteroids, injectable corticosteroids (intraarticular, intramuscular, cutaneous/subcutaneous or intravenous), methotrexate, cyclosporine, cyclophosphamide, apremilast
- Inhaled or intranasal corticosteroids with predominantly local effect (e.g., to treat asthma) are allowable
- Use of corticosteroids in the eye or the ear are allowable
- Other systemic treatments for psoriasis within 4 weeks prior to start of study treatment, e.g., retinoids, fumarates
- Any such treatment used to treat a symptom of psoriasis but not the condition itself (e.g., anti-histamines for pruritus) is not restricted
- Photochemotherapy, e.g., Psoralens + UVA phototherapy (PUVA), within 4 weeks prior to start of study treatment
- Phototherapy, e.g., UVA, UVB, within 2 weeks prior to start of study treatment
- Topical treatments that could affect signs and symptoms of psoriasis within 2 weeks prior to start of study treatment, e.g., corticosteroids, vitamin D analogs, retinoids, pimecrolimus, tacrolimus, tars, keratolytics
- Allowable exceptions are: low or least potent (Class 6 or 7) topical corticosteroids for use on face, palms, soles, and intertriginous areas only; tar and salicylic acid preparations/shampoos for use on scalp only; bland emollient for use on any body region
- Past vaccination with live vaccine within 6 weeks prior to start of study treatment, or plans for administration during the study
- Any investigational or experimental therapy or procedure or participation in any interventional trial within 4 weeks or 5 half-lives (whichever is longer) prior to start of study treatment
- Women of child-bearing potential who are not using reliable means of contraception, e.g., abstinence, surgical sterilization (hysterectomy and/or bilateral oophorectomy or partner vasectomy) or tubal ligation, double barrier method, oral/ injected/ implanted/ transdermal hormonal contraception, intrauterine device or intrauterine system, throughout study participation, and for 4 weeks after the end of treatment
- Women of child-bearing potential who are pregnant or nursing (lactating), or planning a pregnancy while participating in the study
- History of any ongoing, chronic or recurrent infectious disease (with the exception of episodic herpes labialis and herpes genitalis, and vaginal yeast infections)
- Evidence of tuberculosis infection as defined by a positive QuantiFERON®-TB Gold In-Tube test (QFT-G) at Screening, or subjects with an indeterminate QFT-G test result with any retest result as indeterminate or positive
- History of either untreated or incompletely treated latent or active tuberculosis infection
- Ongoing or recent history of any non-psoriatic uncontrolled (in the Investigator's medical opinion) systemic disease, including, but not limited to renal, hepatic, hematologic, gastrointestinal, endocrine, metabolic, pulmonary, cardiac, neurologic, or psychiatric disease. (e.g., A past or current history of hypertension that is controlled with diet and/or medications is not exclusionary.)
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years with the exception of: basal cell or squamous cell carcinoma or actinic keratoses that have been treated or excised with no evidence of recurrence in the past 12 weeks; cervical carcinoma in situ or non-invasive malignant colon polyps that have been removed
- Active systemic infections during the past two weeks (exception: common cold) prior to start of study treatment or any infection that reoccurs on a regular basis
- Past medical history of infection with HIV, hepatitis B or hepatitis C
- History of any allergic reaction to any formulation of abacavir
- Previous treatment with any abacavir-containing product, e.g., Ziagen®, Epzicom®, or Trizivir®
- Previous participation in a clinical study of Prurisol
- Presence of any medical or psychiatric condition that, in the Investgator's opinion, makes it unlikely that the requirements of the protocol will be completed
- History of alcohol or substance abuse, unless in full remission for more than 6 months prior to start of study treatment
- Electrocardiogram (ECG) obtained at Screening visit which shows medically relevant abnormalities which may affect subject safety or interpretation of study results
- Observed clinical laboratory values/abnormalities during Screening that show any one or more of the following:
- Screening total white blood cell (WBC) count <2.5 x 10^9/L, or platelets <100 x 10^9/L or neutrophils <1.2 x 10^9/L or hemoglobin <8.5 g/dL
- Screening serum creatinine level exceeding 2.0 mg/dL (176.8 µmol/L)
- Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 2 x ULN
- Any other severe acute or chronic medical or psychiatric condition or test abnormality(ies) that, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Study Center
Arlington Heights, Illinois, 60005
Study Center
Austin, Texas, 78759
Clinical Study Site
Berlin, New Jersey, 08009
Study Center
Charlottesville, Virginia, 22911
Clinical Study Site
Clarkston, Michigan, 48346
Clinical Study Site
Clinton Township, Michigan, 48038
Study Site
Denver, Colorado, 80209
Clinical Study Site
Denver, Colorado, 80210
Study Site
Glendale, Arizona, 85308
Study Center
Hot Springs, Arkansas, 71913
Clinical Study Site
Houston, Texas, 77004
Study Site
Johnston, Rhode Island, 02919
Study Site
Las Vegas, Nevada, 89106
Study Center
Los Angeles, California, 90017
Study Site
Los Angeles, California, 90036
Study Site
Louisville, Kentucky, 40217
Clinical Study Site
Murrieta, California, 92562
Clinical Study Site
New York, New York, 10012
Clinical Study Site
Oceanside, California, 92056
Study Center
Overland Park, Kansas, 66215
Clinical Study Site
Pflugerville, Texas, 78660
Study Site
Port Orange, Florida, 32127
Clinical Study Site
Portland, Oregon, 97210
Clinical Study Site
Portsmouth, New Hampshire, 03801
Clinical Study Site
Rogers, Arkansas, 72758
Clinical Study Site
San Antonio, Texas, 78213
Clinical Study Site
San Antonio, Texas, 78229
Study Site
San Antonio, Texas, 78229
Study Site
Savannah, Georgia, 31406
Study Site
Sherman Oaks, California, 91403
Clinical Study Site
South Bend, Indiana, 46617
Clinical Study Site
St Louis, Missouri, 63117
Clinical Study Site
Tampa, Florida, 33609
Study Site
Webster, Texas, 77598
About this study
Official title: A Randomized, Double Blind, Parallel Group, Placebo-controlled Trial to Study the Efficacy and Safety of Two Oral Doses of Prurisol Administered Twice Daily for Twelve Weeks to Subjects With Moderate to Severe Chronic Plaque Psoriasis
This study is designed as a randomized, double blind, parallel group, placebo-controlled trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily for twelve weeks to subjects with moderate to severe chronic plaque psoriasis.
Read the detailed description
This study is designed as a randomized, double blind, parallel group, placebo-controlled trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily for twelve weeks to subjects with moderate to severe chronic plaque psoriasis.
Approximately 189 study participants will be enrolled. Subjects will be randomly assigned to one of three treatment groups in a 3:3:1 randomization ratio, respectively.
- Group A (n=81): Prurisol 150 mg bid
- Group B (n=81): Placebo
- Group C (n=27): Prurisol 200 mg bid Outpatient subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy will be recruited to the study. Study participants are required to have a Psoriasis Area and Severity Index (PASI) score ≥ 12, body surface area involvement ≥ 10%, and a static Physician's Global Assessment (sPGA) of moderate or severe (score of 3 or 4).
A subject studied under this clinical protocol will commence with a screening period of up to 4 weeks, a treatment period of 12 weeks, and a follow-up period of 4 weeks ending with an End of Study evaluation.
During treatment, subjects will return to the study center every 2 weeks. Efficacy assessments, including physician and patient rated endpoints, will be measured throughout the study. Safety and tolerability will be assessed by ascertainment of AEs and results of clinical laboratory testing, vital signs assessments, and need for concomitant medications.
At a subset of sites, blood samples for determination of plasma concentrations of Prurisol (abacavir glycolate) and abacavir, it's metabolite, will be obtained from subjects who consent to provide these samples. At selected sites, for those subjects consenting to photography, standardized digital photographs will be obtained for illustrative purposes.
- Conditions
- Chronic Stable Plaque Psoriasis
- Being tested
- Placebo, 400 mg (200 mg BID), 300 mg (150 mg BID)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Two capsules (both containing Placebo enclosed) taken twice a day and approximately 12 hours apart
400 mg (200 mg BID)Drug
Also called Prurisol
Two capsules (both containing two 50mg tablets enclosed) taken twice a day and approximately 12 hours apart
300 mg (150 mg BID)Drug
Also called Prurisol
Two capsules (one containing 50mg tablet and one containing two 50 mg tablets) taken twice a day and approximately 12 hours apart
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Comparator: Placebo daily Two (2) placebo capsules given twice daily (AM and PM) for 84 (± 2 days Receives: Drug: Placebo |
| 300 mg (150 mg BID) | Active comparator | Active Comparator: 300 mg of Prurisol daily One (1) capsule containing 100 mg Prurisol and one (1) capsule containing 50 mg of Prurisol given twice (AM and PM) for 84 (± 2) days Receives: Drug: 300 mg (150 mg BID) |
| 400 mg (200 mg BID) | Active comparator | Active Comparator: 400 mg of Prurisol daily Two (2) capsule each containing 100 mg Prurisol given twice daily (AM and PM) for 84 (± 2) days Receives: Drug: 400 mg (200 mg BID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving at least a 75% reduction from baseline in PASI score (PASI75) at Week 12
The Psoriasis Area and Severity Index (PASI) quantifies the severity of psoriasis based on lesion severity and the percent of body surface area affected. It is a composite assessment, across body regions, reflected in a single score: 0 (no disease) to 72 (maximal disease).
Measured: 12 Weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Reporting of Adverse Events measurements, and reporting of adverse events.
Measured: 16 Weeks
Secondary outcomes (9)
Proportion of subjects achieving a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline
The static Physician Global Assessment reflects an overall severity of the erythema, induration and scaling across all psoriatic lesions on a 5-point scale, where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.
Measured: 16 Weeks
PASI75 response at time points through Week 16
The Psoriasis Area and Severity Index (PASI) quantifies the severity of psoriasis based on lesion severity and the percent of body surface area affected. It is a composite assessment, across body regions, reflected in a single score: 0 (no disease) to 72 (maximal disease).
Measured: 16 Weeks
The actual and change from baseline in patient-reported itch severity score
The severity of itching due to psoriasis will be assessed on a horizontal numeric rating scale, anchored by the terms "No itching" (0) and "Worst possible itching" (10).
Measured: 16 weeks
Assessment of patient-reported quality of life by the Dermatology Life Quality Index (DLQI)
The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology questionnaire that assesses patient health-related quality of life in adult subjects with skin diseases such as psoriasis
Measured: 16 Weeks
Assessment of patient-reported quality of life by the Short Form-36 Health Survey (version 2, acute form)
The SF-36 is a widely used general health status questionnaire that assesses 8 domains of functional health and well-being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions
Measured: 12 Weeks
Assessment of patient-reported quality of life by the Euro-Qol 5 Dimensions Health State Profile
The EQ-5D is a generic instrument designed to assess a subject's general health status. The instrument consists of a questionnaire and a visual analog scale (VAS)
Measured: 12 Weeks
Assessment of Patient Satisfaction with Study Treatment (PSST)
Overall patient satisfaction with study treatment will be assessed on a 7-point rating scale, with response options range from "very dissatisfied" to "very satisfied"
Measured: 12 Weeks
Plasma concentrations of Prurisol
Measurement of Prurisol (abacavir glycolate) from a subset of subjects in the trial
Measured: 4 Weeks
Plasma concentrations of abacavir
Measurement of abacavir, a metabolite of Prurisol, from a subset of subjects in the trial
Measured: Timeframe: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovation Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949388
- Sponsor's protocol ID
- CTIX-PRU-005
- Status last verified
- Jan 2018
- First submitted
- 14 Oct 2016
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Parallel Group, Placebo-controlled Trial to Study the Efficacy and Safety of Two Oral Doses of Prurisol Administered Twice Daily for Twelve Weeks to Subjects With Moderate to Severe Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02949388
- Acronym / sponsor ID
- CTIX-PRU-005
- Conditions
- Chronic Stable Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Innovation Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a randomized, double blind, parallel group, placebo-controlled trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily for twelve weeks to subjects with moderate to severe chronic plaque psoriasis.
Detailed description
This study is designed as a randomized, double blind, parallel group, placebo-controlled trial to study the efficacy and safety of two oral doses of Prurisol administered twice daily for twelve weeks to subjects with moderate to severe chronic plaque psoriasis.
Approximately 189 study participants will be enrolled. Subjects will be randomly assigned to one of three treatment groups in a 3:3:1 randomization ratio, respectively.
- Group A (n=81): Prurisol 150 mg bid
- Group B (n=81): Placebo
- Group C (n=27): Prurisol 200 mg bid Outpatient subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy will be recruited to the study. Study participants are required to have a Psoriasis Area and Severity Index (PASI) score ≥ 12, body surface area involvement ≥ 10%, and a static Physician's Global Assessment (sPGA) of moderate or severe (score of 3 or 4).
A subject studied under this clinical protocol will commence with a screening period of up to 4 weeks, a treatment period of 12 weeks, and a follow-up period of 4 weeks ending with an End of Study evaluation.
During treatment, subjects will return to the study center every 2 weeks. Efficacy assessments, including physician and patient rated endpoints, will be measured throughout the study. Safety and tolerability will be assessed by ascertainment of AEs and results of clinical laboratory testing, vital signs assessments, and need for concomitant medications.
At a subset of sites, blood samples for determination of plasma concentrations of Prurisol (abacavir glycolate) and abacavir, it's metabolite, will be obtained from subjects who consent to provide these samples. At selected sites, for those subjects consenting to photography, standardized digital photographs will be obtained for illustrative purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator: Placebo daily Two (2) placebo capsules given twice daily (AM and PM) for 84 (± 2 days |
| 300 mg (150 mg BID) | Active comparator | Drug: 300 mg (150 mg BID)Active Comparator: 300 mg of Prurisol daily One (1) capsule containing 100 mg Prurisol and one (1) capsule containing 50 mg of Prurisol given twice (AM and PM) for 84 (± 2) days |
| 400 mg (200 mg BID) | Active comparator | Drug: 400 mg (200 mg BID)Active Comparator: 400 mg of Prurisol daily Two (2) capsule each containing 100 mg Prurisol given twice daily (AM and PM) for 84 (± 2) days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Evidence of a personally signed and dated written informed consent to participate in the clinical study
- Male or non-pregnant female adults at least 18 years of age at time of informed consent
- Chronic plaque-type psoriasis diagnosed for at least 6 months prior to baseline (at time of first study dose)
- Moderate to severe plaque psoriasis as defined at baseline by:
- Candidate for systemic therapy or phototherapy
Key exclusion criteria (39 listed)
- Positive blood test for HLA-B*5701 allele
- Currently have forms of psoriasis other than chronic plaque-type, (e.g., guttate, erythrodermic, exfoliative, palmoplantar, pustular), with the exception of nail psoriasis
- Evidence of drug-induced psoriasis, e.g., a new onset or current exacerbation of psoriasis from beta-blockers, calcium channel inhibitors, antimalarial drugs or lithium
- Psoriasis flare or rebound within 4 weeks prior to Screening
- Active inflammatory diseases other than psoriasis that might confound the evaluation of study treatment on signs and symptoms of psoriasis.
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 |
|---|---|---|
| PlaceboTwo capsules (both containing Placebo enclosed) taken twice a day and approximately 12 hours apart | Drug | Placebo |
| 400 mg (200 mg BID)Also: PrurisolTwo capsules (both containing two 50mg tablets enclosed) taken twice a day and approximately 12 hours apart | Drug | 400 mg (200 mg BID) |
| 300 mg (150 mg BID)Also: PrurisolTwo capsules (one containing 50mg tablet and one containing two 50 mg tablets) taken twice a day and approximately 12 hours apart | Drug | 300 mg (150 mg BID) |
Primary outcome
Proportion of participants achieving at least a 75% reduction from baseline in PASI score (PASI75) at Week 12
Time frame: 12 Weeks
The Psoriasis Area and Severity Index (PASI) quantifies the severity of psoriasis based on lesion severity and the percent of body surface area affected. It is a composite assessment, across body regions, reflected in a single score: 0 (no disease) to 72 (maximal disease).
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 16 Weeks
Reporting of Adverse Events measurements, and reporting of adverse events.
9 secondary outcomes
Proportion of subjects achieving a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline
Time frame: 16 Weeks
PASI75 response at time points through Week 16
Time frame: 16 Weeks
The actual and change from baseline in patient-reported itch severity score
Time frame: 16 weeks
Assessment of patient-reported quality of life by the Dermatology Life Quality Index (DLQI)
Time frame: 16 Weeks
Assessment of patient-reported quality of life by the Short Form-36 Health Survey (version 2, acute form)
Time frame: 12 Weeks
Assessment of patient-reported quality of life by the Euro-Qol 5 Dimensions Health State Profile
Time frame: 12 Weeks
Assessment of Patient Satisfaction with Study Treatment (PSST)
Time frame: 12 Weeks
Plasma concentrations of Prurisol
Time frame: 4 Weeks
Plasma concentrations of abacavir
Time frame: Timeframe: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Individual participant dataSharing planned: No
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.
34 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 400 mg (200 mg BID) and 300 mg (150 mg BID) in people with Chronic Stable Plaque Psoriasis, run by Innovation Pharmaceuticals, Inc. at 34 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 10 inclusion and 39 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: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 participants achieving at least a 75% reduction from baseline in PASI score (PASI75) at Week 12 (time frame: 12 Weeks). The study lists 2 primary outcomes in all. 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 13 Feb 2018.