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

Phase 1

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: dalazatide; Drug: placebo

• Registration Number: NCT02435342
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-10
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-04-15
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-01
• Last Update Submitted: 2015-05-01
• Study First Posted: 2015-05-06
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30ug dalazatide	dalazatide	12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
30ug dalazatide	placebo	12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
60ug dalazatide	placebo	12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.
60ug dalazatide	dalazatide	12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Subjects with adverse events	From randomization through Day 57 (12 timepoints)

Secondary Outcome Measures

Name	Time	Method
Target lesion assessment	From randomization to Day 57 (4 timepoints)	Target lesion evaluated for erythema, induration, and scaling.
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)	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	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)	From randomization to Day 57 (4 timepoints)
Presence of specific anti-drug antibodies to dalazatide	From randomization to Day 57 (three timepoints)	Serum evaluated for specific anti-drug antibody using ELISA-based immunoassay.
Psoriasis Disability Index (PDI)	From randomization to Day 57 (4 timepoints)
Subjects with changes in vital signs	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	From randomization to day 5 (12 timepoints)

Trial Locations

Locations (1)

Innovaderm Research, Inc; 🇨🇦 Montreal, Quebec, Canada