Clinical Trials/NCT02435342

NCT02435342

Completed

Phase 1

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

Kineta Inc.1 site in 1 country24 target enrollmentOctober 2014

ConditionsPlaque Psoriasis

Interventionsdalazatide placebo

Drugsdalazatide placebo

Overview

Phase: Phase 1
Intervention: dalazatide
Conditions: Plaque Psoriasis
Sponsor: Kineta Inc.
Enrollment: 24
Locations: 1
Primary Endpoint: Subjects with adverse events
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

March 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kineta Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;

Exclusion Criteria

•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;
•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;

Arms & Interventions

30ug dalazatide

12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.

Intervention: dalazatide

30ug dalazatide

12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.

Intervention: placebo

60ug dalazatide

12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.

Intervention: dalazatide

60ug dalazatide

12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.

Intervention: placebo

Outcomes

Primary Outcomes

Subjects with adverse events

Time Frame: From randomization through Day 57 (12 timepoints)

Secondary Outcomes

Target lesion assessment(From randomization to Day 57 (4 timepoints))
Psoriasis Area Severity Index (PASI) score(From randomization to Day 57 (4 timepoints))
Patient and Investigator Global Assessment of Psoriasis(From randomization to Day 57 (4 timepoints))
Skin biomarker assessments(From randomaization to Day 32 (2 timepoints))
Blood biomarker assessments(From randomizatoin to Day 57 (5 timepoints))
Dermatology Quality of Life Questionnaire (DLQI)(From randomization to Day 57 (4 timepoints))
Presence of specific anti-drug antibodies to dalazatide(From randomization to Day 57 (three timepoints))
Psoriasis Disability Index (PDI)(From randomization to Day 57 (4 timepoints))
Subjects with changes in vital signs(From randomization to Day 57 (12 timepoints))
Subjects with changes in symptom-directed physical examinations(From randomization to day 5 (12 timepoints))