Plaque PsoriasisPhase 1NCT02435342
A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 (Dalazatide) in Active Plaque Psoriasis
A Phase 1 study testing dalazatide in people with Plaque Psoriasis, run by Kineta Inc. at 1 site in Canada.
Trial summary
The primary purpose of this study is to examine safety outcomes in active plaque psoriasis patients after systemic administration of dalazatide. Clinical outcome measures will also be assessed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- dalazatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Mar 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female subjects, ages 18-65;
- Active plaque psoriasis with ≥3% BSA involved;
- An adequate number of vulgar psoriatic plaques of at least 2 cm X 2 cm with Target Lesion Investigator Global Assessment scores >3, that are not located on the face, scalp, groin, genitals, folds, palms or soles
- Weight of 50 - 100 kg;
- Non-child bearing potential or willingness to use adequate contraception in order to prevent pregnancy from the screening visit until 60 days after the follow-up visit.
- Subject will be evaluated for latent TB infection.
- Able to communicate and able to provide valid, written informed consent;
Who cannot join
- The following will exclude potential subjects from the study:
- Erythrodermic, predominantly guttate, exclusively palmar/plantar, or generalized pustular psoriasis;
- Current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate);
- Use of the following concurrent systemic medications: corticosteroids, retinoids, cyclosporine, methotrexate, or biologic agents.
- Use of concurrent topical medications (must be discontinued at least 2 weeks prior to baseline);
- UVA or UVB therapy within 4 weeks of baseline;
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- The presence of uncontrolled hypertension, uncontrolled diabetes, clinically significant cardiovascular disease, asthma or reduced pulmonary capacity, or a history of seizure or other neurologic disorder;
- Presence or history of pre-existing paresthesia or neuropathy;
- Abnormalities on neurological exam at screening or baseline;
- Clinically significant ECG abnormalities, in the opinion of the Investigator;
- History of any cancer requiring systemic chemotherapy or radiation;
- The presence of acute infection or history of acute infection as judged by the Investigator within 7 days of baseline;
- The presence of clinically significant laboratory abnormalities;
- A positive hepatitis screen (Hepatitis BsAg or anti-HCV) or positive Human Immunodeficiency Virus (HIV) antibody test ;
- History of treated or untreated TB
- Any history of anaphylaxis that is important in the view of the Investigator;
- Participation in another clinical trial with receipt of an investigational product within 90 days of baseline (or 5 half-lives of the previous drug, whichever is longer);
- History of alcohol abuse that is important in the view of the Investigator;
- Positive drug screen for amphetamines, barbituates, benzodiazepines, cocaine, cannabis, methamphetamine, methylenedioxymethanphetamine, opiates or phencyclidine
- Inadequate venous access that would interfere with obtaining blood samples;
- Positive pregnancy test at screening or at baseline or current lactation (female subjects only);
- Inability or unwillingness to comply with study restrictions, return for follow up appointments, or other considerations, in the opinion of the Investigator, which would make the candidate unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 in Active Plaque Psoriasis
The primary purpose of this study is to examine safety outcomes in active plaque psoriasis patients after systemic administration of dalazatide. Clinical outcome measures will also be assessed.
Read the detailed description
The primary purpose of this study is to examine safety outcomes in active plaque psoriasis patients after systemic administration of dalazatide. Clinical outcome measures will also be assessed.
- Conditions
- Plaque Psoriasis
- Being tested
- dalazatide, placebo
- Keywords
- ShK-186, dalazatide, psoriasis, Kv1.3,, autoimmune
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalazatideDrug
Also called ShK-186
Subcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up.
placeboDrug
placebo, Subcutaneous injection twice per week for a total of 9 doses
| Study group | Role | What they receive |
|---|---|---|
| 30ug dalazatide | Experimental | 12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks. Receives: Drug: dalazatide; Drug: placebo |
| 60ug dalazatide | Experimental | 12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks. Receives: Drug: dalazatide; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects with adverse events
Measured: From randomization through Day 57 (12 timepoints)
Secondary outcomes (10)
Target lesion assessment
Target lesion evaluated for erythema, induration, and scaling.
Measured: From randomization to Day 57 (4 timepoints)
Psoriasis Area Severity Index (PASI) score
Measured: From randomization to Day 57 (4 timepoints)
Patient and Investigator Global Assessment of Psoriasis
Measured: From randomization to Day 57 (4 timepoints)
Psoriasis Disability Index (PDI)
Measured: From randomization to Day 57 (4 timepoints)
Skin biomarker assessments
Skin biopsy from psoriatic lesion collected for analysis of gene expression via qPCR and immune cell infiltration via histology and immunohistochemistry analysis.
Measured: From randomaization to Day 32 (2 timepoints)
Blood biomarker assessments
Blood collected for analysis of gene and protein expression as well as immunophenotyping of T cell subsets.
Measured: From randomizatoin to Day 57 (5 timepoints)
Dermatology Quality of Life Questionnaire (DLQI)
Measured: From randomization to Day 57 (4 timepoints)
Presence of specific anti-drug antibodies to dalazatide
Serum evaluated for specific anti-drug antibody using ELISA-based immunoassay.
Measured: From randomization to Day 57 (three timepoints)
Subjects with changes in vital signs
Vital signs include temperature, respiratory rate, supine blood pressure and pulse.
Measured: From randomization to Day 57 (12 timepoints)
Subjects with changes in symptom-directed physical examinations
Measured: From randomization to day 5 (12 timepoints)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kineta Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shawn Iadonato, PhD, Study director, Kineta Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435342
- Sponsor's protocol ID
- 186-03
- Status last verified
- May 2015
- First submitted
- 15 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 in Active Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT02435342
- Acronym / sponsor ID
- 186-03
- Conditions
- Plaque Psoriasis
- Keywords
- ShK-186, dalazatide, psoriasis, Kv1.3,, autoimmune
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kineta Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 May 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.
The primary purpose of this study is to examine safety outcomes in active plaque psoriasis patients after systemic administration of dalazatide. Clinical outcome measures will also be assessed.
Detailed description
The primary purpose of this study is to examine safety outcomes in active plaque psoriasis patients after systemic administration of dalazatide. Clinical outcome measures will also be assessed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30ug dalazatide | Experimental | Drug: dalazatide, Drug: placebo12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks. |
| 60ug dalazatide | Experimental | Drug: dalazatide, Drug: placebo12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult male and female subjects, ages 18-65;
- Active plaque psoriasis with ≥3% BSA involved;
- An adequate number of vulgar psoriatic plaques of at least 2 cm X 2 cm with Target Lesion Investigator Global Assessment scores >3, that are not located on the face, scalp, groin, genitals, folds, palms or soles
- Weight of 50 - 100 kg;
- Non-child bearing potential or willingness to use adequate contraception in order to prevent pregnancy from the screening visit until 60 days after the follow-up visit.
Key exclusion criteria (22 listed)
- Erythrodermic, predominantly guttate, exclusively palmar/plantar, or generalized pustular psoriasis;
- Current drug-induced or aggravated psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta-blockers, calcium-channel blockers, or lithium carbonate);
- Use of the following concurrent systemic medications: corticosteroids, retinoids, cyclosporine, methotrexate, or biologic agents.
- Use of concurrent topical medications (must be discontinued at least 2 weeks prior to baseline);
- UVA or UVB therapy within 4 weeks of baseline;
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 |
|---|---|---|
| dalazatideAlso: ShK-186Subcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up. | Drug | 30ug dalazatide, 60ug dalazatide |
| placeboplacebo, Subcutaneous injection twice per week for a total of 9 doses | Drug | 30ug dalazatide, 60ug dalazatide |
Primary outcome
Subjects with adverse events
Time frame: From randomization through Day 57 (12 timepoints)
10 secondary outcomes
Target lesion assessment
Time frame: From randomization to Day 57 (4 timepoints)
Psoriasis Area Severity Index (PASI) score
Time frame: From randomization to Day 57 (4 timepoints)
Patient and Investigator Global Assessment of Psoriasis
Time frame: From randomization to Day 57 (4 timepoints)
Psoriasis Disability Index (PDI)
Time frame: From randomization to Day 57 (4 timepoints)
Skin biomarker assessments
Time frame: From randomaization to Day 32 (2 timepoints)
Blood biomarker assessments
Time frame: From randomizatoin to Day 57 (5 timepoints)
Dermatology Quality of Life Questionnaire (DLQI)
Time frame: From randomization to Day 57 (4 timepoints)
Presence of specific anti-drug antibodies to dalazatide
Time frame: From randomization to Day 57 (three timepoints)
Subjects with changes in vital signs
Time frame: From randomization to Day 57 (12 timepoints)
Subjects with changes in symptom-directed physical examinations
Time frame: From randomization to day 5 (12 timepoints)
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 6 May 2015.
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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.
Shawn Iadonato, PhD study director
Kineta Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dalazatide in people with Plaque Psoriasis, run by Kineta Inc. at 1 site in Canada.
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 7 inclusion and 22 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 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 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?
Subjects with adverse events (time frame: From randomization through Day 57 (12 timepoints)). 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 May 2015; AzTrials last refreshed its copy on 6 Nov 2026.