Clinical trial NCT02435342: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Plaque Psoriasis
Keywords: ShK-186
dalazatide
psoriasis
Kv1.3,
autoimmune
Lead sponsor: Kineta Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Primary outcomes:
measure: Subjects with adverse events
timeFrame: From randomization through Day 57 (12 timepoints)
Secondary outcomes:
measure: Target lesion assessment
timeFrame: From randomization to Day 57 (4 timepoints)
measure: Psoriasis Area Severity Index (PASI) score
timeFrame: From randomization to Day 57 (4 timepoints)
measure: Patient and Investigator Global Assessment of Psoriasis
timeFrame: From randomization to Day 57 (4 timepoints)
measure: Psoriasis Disability Index (PDI)
timeFrame: From randomization to Day 57 (4 timepoints)
measure: Skin biomarker assessments
timeFrame: From randomaization to Day 32 (2 timepoints)
measure: Blood biomarker assessments
timeFrame: From randomizatoin to Day 57 (5 timepoints)
measure: Dermatology Quality of Life Questionnaire (DLQI)
timeFrame: From randomization to Day 57 (4 timepoints)
measure: Presence of specific anti-drug antibodies to dalazatide
timeFrame: From randomization to Day 57 (three timepoints)
measure: Subjects with changes in vital signs
timeFrame: From randomization to Day 57 (12 timepoints)
measure: Subjects with changes in symptom-directed physical examinations
timeFrame: From randomization to day 5 (12 timepoints)
Other outcomes:
measure: Area under the plasma concentration versus time curve of dalazatide (AUC)
timeFrame: 5 minutes pose dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 4 hours post dose
Locations:
city: Montreal
country: Canada
facility: Innovaderm Research, Inc
state: Quebec
Study officials:
affiliation: Kineta Inc.
name: Shawn Iadonato, PhD
role: STUDY_DIRECTOR
References: