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

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

Tracking Information

• First Submitted Date: April 15, 2015
• First Posted Date: May 6, 2015
• Last Update Posted Date: May 6, 2015
• Study Start Date: October 2014
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 1, 2015): Subjects with adverse events [ Time Frame: From randomization through Day 57 (12 timepoints) ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 1, 2015)

• Target lesion assessment [ Time Frame: From randomization to Day 57 (4 timepoints) ]
  Target lesion evaluated for erythema, induration, and scaling.
• 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) ]
  Skin biopsy from psoriatic lesion collected for analysis of gene expression via qPCR and immune cell infiltration via histology and immunohistochemistry analysis.
• 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.
• 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) ]
  Serum evaluated for specific anti-drug antibody using ELISA-based immunoassay.
• 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.
• Subjects with changes in symptom-directed physical examinations [ Time Frame: From randomization to day 5 (12 timepoints) ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: May 1, 2015): 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 ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 (Dalazatide) in Active Plaque Psoriasis
• Official Title: A 4 Week Study of the Safety, Tolerability, and Pharmacodynamics of ShK-186 in Active Plaque Psoriasis
• 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.
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator)
• Condition: Plaque Psoriasis

Intervention

• 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

Study Arms

• Experimental: 30ug dalazatide
  12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
  Interventions:

  • Drug: dalazatide
  • Drug: placebo
• Experimental: 60ug dalazatide
  12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
  Interventions:

  • Drug: dalazatide
  • Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 1, 2015): 24
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2015
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02435342
• Other Study ID Numbers: 186-03
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kineta Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Kineta Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Shawn Iadonato, PhD; Kineta Inc.

• PRS Account: Kineta Inc.
• Verification Date: May 2015