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Trial record 7 of 811 for:    Psoriasis 4

A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 (Dalazatide) in Active Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02435342
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):
Kineta Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: dalazatide Drug: placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 in Active Plaque Psoriasis
Study Start Date : October 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 30ug dalazatide
12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
Drug: dalazatide
Subcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up.
Other Name: ShK-186

Drug: placebo
placebo, Subcutaneous injection twice per week for a total of 9 doses

Experimental: 60ug dalazatide
12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
Drug: dalazatide
Subcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up.
Other Name: ShK-186

Drug: placebo
placebo, Subcutaneous injection twice per week for a total of 9 doses




Primary Outcome Measures :
  1. Subjects with adverse events [ Time Frame: From randomization through Day 57 (12 timepoints) ]

Secondary Outcome Measures :
  1. Target lesion assessment [ Time Frame: From randomization to Day 57 (4 timepoints) ]
    Target lesion evaluated for erythema, induration, and scaling.

  2. Psoriasis Area Severity Index (PASI) score [ Time Frame: From randomization to Day 57 (4 timepoints) ]
  3. Patient and Investigator Global Assessment of Psoriasis [ Time Frame: From randomization to Day 57 (4 timepoints) ]
  4. Psoriasis Disability Index (PDI) [ Time Frame: From randomization to Day 57 (4 timepoints) ]
  5. Skin biomarker assessments [ Time Frame: From randomaization to Day 32 (2 timepoints) ]
    Skin biopsy from psoriatic lesion collected for analysis of gene expression via qPCR and immune cell infiltration via histology and immunohistochemistry analysis.

  6. Blood biomarker assessments [ Time Frame: From randomizatoin to Day 57 (5 timepoints) ]
    Blood collected for analysis of gene and protein expression as well as immunophenotyping of T cell subsets.

  7. Dermatology Quality of Life Questionnaire (DLQI) [ Time Frame: From randomization to Day 57 (4 timepoints) ]
  8. Presence of specific anti-drug antibodies to dalazatide [ Time Frame: From randomization to Day 57 (three timepoints) ]
    Serum evaluated for specific anti-drug antibody using ELISA-based immunoassay.

  9. Subjects with changes in vital signs [ Time Frame: From randomization to Day 57 (12 timepoints) ]
    Vital signs include temperature, respiratory rate, supine blood pressure and pulse.

  10. Subjects with changes in symptom-directed physical examinations [ Time Frame: From randomization to day 5 (12 timepoints) ]

Other Outcome Measures:
  1. Area under the plasma concentration versus time curve of dalazatide (AUC) [ Time Frame: 5 minutes pose dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 4 hours post dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult male and female subjects, ages 18-65;
  2. Active plaque psoriasis with ≥3% BSA involved;
  3. 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
  4. Weight of 50 - 100 kg;
  5. 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.
  6. Subject will be evaluated for latent TB infection.
  7. Able to communicate and able to provide valid, written informed consent;

Exclusion Criteria:

The following will exclude potential subjects from the study:

  1. Erythrodermic, predominantly guttate, exclusively palmar/plantar, or generalized pustular psoriasis;
  2. 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);
  3. Use of the following concurrent systemic medications: corticosteroids, retinoids, cyclosporine, methotrexate, or biologic agents.
  4. Use of concurrent topical medications (must be discontinued at least 2 weeks prior to baseline);
  5. UVA or UVB therapy within 4 weeks of baseline;
  6. 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;
  7. Presence or history of pre-existing paresthesia or neuropathy;
  8. Abnormalities on neurological exam at screening or baseline;
  9. Clinically significant ECG abnormalities, in the opinion of the Investigator;
  10. History of any cancer requiring systemic chemotherapy or radiation;
  11. The presence of acute infection or history of acute infection as judged by the Investigator within 7 days of baseline;
  12. The presence of clinically significant laboratory abnormalities;
  13. A positive hepatitis screen (Hepatitis BsAg or anti-HCV) or positive Human Immunodeficiency Virus (HIV) antibody test ;
  14. History of treated or untreated TB
  15. Any history of anaphylaxis that is important in the view of the Investigator;
  16. 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);
  17. History of alcohol abuse that is important in the view of the Investigator;
  18. Positive drug screen for amphetamines, barbituates, benzodiazepines, cocaine, cannabis, methamphetamine, methylenedioxymethanphetamine, opiates or phencyclidine
  19. Inadequate venous access that would interfere with obtaining blood samples;
  20. Positive pregnancy test at screening or at baseline or current lactation (female subjects only);
  21. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435342


Locations
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Canada, Quebec
Innovaderm Research, Inc
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Kineta Inc.
Investigators
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Study Director: Shawn Iadonato, PhD Kineta Inc.

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Responsible Party: Kineta Inc.
ClinicalTrials.gov Identifier: NCT02435342     History of Changes
Other Study ID Numbers: 186-03
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015
Keywords provided by Kineta Inc.:
ShK-186
dalazatide
psoriasis
Kv1.3,
autoimmune
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases