PsoriasisPhase 1NCT02630901
Multiple Ascending Dose Study of PRX003 in Subjects With Psoriasis
A Phase 1 study testing PRX003 in people with Psoriasis, run by Prothena Biosciences Limited at 9 sites in United States.
Trial summary
This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 56 patients with Psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- PRX003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 9 sitesUnited States
- Study dates
- 17 Mar 2016to 28 Feb 2018
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 80 years of age (inclusive), body weight range of ≥ 45 kg (99 lbs) to ≤ 120 kg (264 lbs) and a body mass index (BMI) of 18 - 35 kg/m2
- Provide written informed consent
- PASI score of ≥12
- Plaque psoriasis covering ≥10% of BSA
- s-PGA score of 3 or 4
- Able to perform all protocol-specified assessments and comply with the study visit schedule
- Female subjects who are not postmenopausal or surgically sterile must use physician approved contraception for at least 60 days prior to Baseline (Day 1/Visit 2) to 12 weeks following the last study drug administration. Unless they are at least 2 years postmenopausal or surgically sterile, women must have a pregnancy test with follicle stimulating hormone (FSH) >40 IU/L and estradiol <20 pg/mL (unless on hormone-replacement therapy). Women of childbearing potential must be non lactating and have a negative serum pregnancy test (beta human chorionic gonadotropin [β HCG]) at Screening (Visit 1).
- If male, must be surgically sterile or must agree to use physician-approved contraception from Baseline (Day 1/Visit 2) to 12 weeks following the last study drug administration
Who cannot join
- Presents with psoriasis that is predominantly guttate, erythrodermic, inverse, pustular or palmo-plantar, or an unstable form of psoriasis
- Receipt of any of the following within the specified time frame prior to Baseline (Day 1/Visit 2):
- Topical psoriasis treatments (other than low-potency topical corticosteroids or emollients, which are permitted during the study) within 2 weeks
- Systemic (nonbiologic) psoriasis treatments within 4 weeks or 5 half-lives (whichever is longer)
- Biologic psoriasis treatments within 12 weeks or 5 half-lives (whichever is longer)
- Drugs that appear to have a strong causal relationship to psoriasis (e.g., beta-blockers and lithium) within 4 weeks or 5 half-lives (whichever is longer)
Show all 34Show fewer
- Phototherapy within 4 weeks
- Participation in recreational sunbathing or use of a sun-bed (e.g., tanning salon) within 7 days prior to Baseline (Day 1)
- Any major medical illness or unstable medical condition that, in the opinion of the Investigator or Sponsor, may interfere with the subject's ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data, including, but not limited to:
- Within 5 years of Screening (Visit 1)
- History of cancer with the exception of fully excised non-melanoma skin cancer
- History of stroke
- History of epilepsy or seizure disorder other than febrile seizures as a child, or any seizure or loss of consciousness
- History of or active autoimmune disease (other than psoriasis or PsA)
- Within 2 years of Screening (Visit 1)
- Myocardial infarction
- Clinically significant cardiovascular disease including any of the following: unstable angina, decompensated congestive heart failure, clinically significant arrhythmias
- Vascular diseases, including, but not limited to, blood clotting disorders, atherosclerosis, aneurysms, and renal artery disease
- Hypotension (systolic blood pressure [BP] ≤85 millimeters of mercury [mmHg]) at Baseline (Day 1/Visit 2) predose or a known history or documentation of hypotension on more than one occasion within 3 months prior to Baseline (Day 1/Visit 2)
- Uncontrolled hypertension as indicated by a resting systolic BP ≥150 mmHg or diastolic BP ≥95 mmHg at Screening (Visit 1) or Baseline (Day 1/Visit 2) predose or a known history or documentation of uncontrolled hypertension on more than one occasion within 3 months prior to Baseline (Day 1/Visit 2)
- Clinically significant systemic infection (e.g., chronic or acute infection, urinary tract infection, upper respiratory infection) within 30 days of Baseline (Day 1/ Visit 2), or a history or presence of recurrent or chronic infection (e.g., viral infections [including hepatitis B or C, human immunodeficiency virus (HIV)], bacterial infections, systemic fungal infections, or syphilis)
- History of any inflammatory bowel disease
- Any current psychiatric diagnosis according to Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV-TR) that may interfere with the subject's ability to perform the study and all assessments (e.g., alcohol or drug-related abuse or alcohol dependence, or alcohol or drug-related dementia, major depression, developmental disability, schizophrenia, bipolar disorder). Note: Subjects with adequately controlled depression for at least 6 months are not excluded; however, suicidal ideation or attempt at any time within the past year is exclusionary.
- A positive tuberculosis skin test (TST) or a positive interferon-gamma release assay (IGRA) during Screening (Visit 1).
- Note: In the event a subject has had a TST or IGRA within 3 months before Baseline (Day 1/Visit 2), this does not need to be repeated during screening and the previous result can be carried forward and used in this study.
- Prior standard treatment for latent tuberculosis and prior exposure to tuberculosis with subsequent standard prophylactic treatment is allowed if recent (within ˂ 30 days) negative chest X-ray.
- Any of the following laboratory abnormalities at Screening (Visit 1):
- Total bilirubin (unless attributed to Gilbert's syndrome) >1.5 times the upper limit of normal (× ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × ULN
- Serum creatinine >133 µmol/L (1.5 mg/dL)
- Hemoglobin <11.5 g/dL for males or <10.0 g/dL for females, absolute neutrophil count of ˂1500/µL (with the exception of a documented history of a chronic benign neutropenia), or platelet count of <120,000/µL
- Use of an investigational product or device or participation in a drug research study within a period of 30 days (or 5 half-lives of the drug, whichever is longer) prior to Screening (Visit 1); for investigational products or drug research studies relating to psoriasis or arthritis, the duration will be extended to 12 weeks (or 5 half-lives of the drug, whichever is longer) prior to Screening (Visit 1)
- Allergy to any of the components of PRX003 such as histidine, sucrose and polysorbate 20
- Receipt of any vaccine (with the exception of seasonal influenza) within 30 days prior to Screening (Visit 1)
- Donation of >500 mL of blood within 3 months prior to Screening (Visit 1)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Universal Medical and Research Center, LLC
Coral Gables, Florida
Dermatology Treatment and Research Center, PA
Dallas, Texas
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Virginia Clinical Research Inc.
Norfolk, Virginia, 23502
Renstar Medical Research
Ocala, Florida, 34471
UPMC Department of Dermatology
Pittsburgh, Pennsylvania, 15213
Clinical Trials of Texas, Inc.
San Antonio, Texas
TCR Medical Corporation
San Diego, California, 92123
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of PRX003 Administered by Intravenous Infusion in Subjects With Psoriasis
This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 56 patients with Psoriasis.
- Conditions
- Psoriasis
- Being tested
- PRX003, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX003Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| PRX003 | Experimental | Not described Receives: Drug: PRX003 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as determined by number of subjects with adverse events
Measured: 6 months
Determination of pharmacokinetics parameters
time of the maximum measured concentration (Tmax)
Measured: 20 weeks
Determination of pharmacokinetics parameters
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Measured: 20 weeks
Determination of pharmacokinetics parameters
maximum concentration (Cmax)
Measured: 20 weeks
Determination of pharmacokinetics parameters
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Measured: 20 weeks
Determination of pharmacokinetics parameters
elimination rate constant
Measured: 20 weeks
Determination of pharmacokinetics parameters
terminal elimination half life (t½)
Measured: 20 weeks
Determination of pharmacokinetics parameters
clearance (CL)
Measured: 20 weeks
Determination of pharmacokinetics parameters
apparent volume of distribution (Vd)
Measured: 20 weeks
Determination of pharmacokinetics parameters
average concentration over a dosing interval (Cav)
Measured: 20 weeks
Determination of pharmacokinetics parameters
area under the plasma concentration-time curve for a dosing interval (AUCtau)
Measured: 20 weeks
Determination of pharmacokinetics parameters
minimum observed concentration (Cmin)
Measured: 20 weeks
Secondary outcomes (1)
Immunogenicity as determined by measurement of anti-PRX003 antibodies
antibody titers will be listed and summarized
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study start17 Mar 2016
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prothena Biosciences Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630901
- Sponsor's protocol ID
- PRX003-102
- Status last verified
- Sep 2016
- First submitted
- 11 Dec 2015
- Last updated
- 4 May 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 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of PRX003 Administered by Intravenous Infusion in Subjects With Psoriasis
- ClinicalTrials.gov ID
- NCT02630901
- Acronym / sponsor ID
- PRX003-102
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Prothena Biosciences LimitedIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2016 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 15 Dec 2015 (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 multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 56 patients with Psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRX003 | Experimental | Drug: PRX003 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, 18 to 80 years of age (inclusive), body weight range of ≥ 45 kg (99 lbs) to ≤ 120 kg (264 lbs) and a body mass index (BMI) of 18 - 35 kg/m2
- Provide written informed consent
- PASI score of ≥12
- Plaque psoriasis covering ≥10% of BSA
- s-PGA score of 3 or 4
Key exclusion criteria (34 listed)
- Presents with psoriasis that is predominantly guttate, erythrodermic, inverse, pustular or palmo-plantar, or an unstable form of psoriasis
- Receipt of any of the following within the specified time frame prior to Baseline (Day 1/Visit 2):
- Participation in recreational sunbathing or use of a sun-bed (e.g., tanning salon) within 7 days prior to Baseline (Day 1)
- Any major medical illness or unstable medical condition that, in the opinion of the Investigator or Sponsor, may interfere with the subject's ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data, including, but not limited to:
- Hypotension (systolic blood pressure [BP] ≤85 millimeters of mercury [mmHg]) at Baseline (Day 1/Visit 2) predose or a known history or documentation of hypotension on more than one occasion within 3 months prior to Baseline (Day 1/Visit 2)
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 |
|---|---|---|
| PRX003 | Drug | PRX003 |
| Placebo | Other | Placebo |
Primary outcome
Safety and tolerability as determined by number of subjects with adverse events
Time frame: 6 months
Determination of pharmacokinetics parameters
Time frame: 20 weeks
time of the maximum measured concentration (Tmax)
Determination of pharmacokinetics parameters
Time frame: 20 weeks
area under the concentration-time curve from time zero to the last quantifiable concentration time-point (AUClast)
Determination of pharmacokinetics parameters
Time frame: 20 weeks
maximum concentration (Cmax)
Determination of pharmacokinetics parameters
Time frame: 20 weeks
area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)
Determination of pharmacokinetics parameters
Time frame: 20 weeks
elimination rate constant
Determination of pharmacokinetics parameters
Time frame: 20 weeks
terminal elimination half life (t½)
Determination of pharmacokinetics parameters
Time frame: 20 weeks
clearance (CL)
Determination of pharmacokinetics parameters
Time frame: 20 weeks
apparent volume of distribution (Vd)
Determination of pharmacokinetics parameters
Time frame: 20 weeks
average concentration over a dosing interval (Cav)
Determination of pharmacokinetics parameters
Time frame: 20 weeks
area under the plasma concentration-time curve for a dosing interval (AUCtau)
Determination of pharmacokinetics parameters
Time frame: 20 weeks
minimum observed concentration (Cmin)
1 secondary outcome
Immunogenicity as determined by measurement of anti-PRX003 antibodies
Time frame: 20 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 4 May 2018.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRX003 in people with Psoriasis, run by Prothena Biosciences Limited at 9 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 8 inclusion and 34 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 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and tolerability as determined by number of subjects with adverse events (time frame: 6 months). The study lists 12 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 4 May 2018.