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

NCT02435342 | Completed Phase 1 DMC

• 1 other identifier: 186-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Keywords

ShK-186; dalazatide; psoriasis; Kv1.3,; autoimmune

Outcome Measures

Primary Outcomes (1)

• Subjects with adverse events

  From randomization through Day 57 (12 timepoints)

Secondary Outcomes (10)

• 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)

• Psoriasis Disability Index (PDI)

  From randomization to Day 57 (4 timepoints)

• Skin biomarker assessments

  From randomaization to Day 32 (2 timepoints)

Other Outcomes (1)

• Area under the plasma concentration versus time curve of dalazatide (AUC)

  5 minutes pose dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 4 hours post dose

Study Arms (2)

30ug dalazatide

EXPERIMENTAL

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

Drug: dalazatide; Drug: placebo

60ug dalazatide

EXPERIMENTAL

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

Drug: dalazatide; Drug: placebo

Interventions

dalazatide DRUG

Subcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up.

Also known as: ShK-186

30ug dalazatide; 60ug dalazatide

placebo DRUG

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

30ug dalazatide; 60ug dalazatide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• History of any cancer requiring systemic chemotherapy or radiation;
• The presence of acute infection or history of acute infection as judged by the Investigator within 7 days of baseline;
• The presence of clinically significant laboratory abnormalities;
• A positive hepatitis screen (Hepatitis BsAg or anti-HCV) or positive Human Immunodeficiency Virus (HIV) antibody test ;
• History of treated or untreated TB

Sponsors & Collaborators

• Kineta Inc.: lead

Study Sites (1)

Innovaderm Research, Inc

Montreal, Quebec, H2K 4L5, Canada

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Shk-186 peptide

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shawn Iadonato, PhD

  Kineta Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: May 6, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 6, 2015

Record last verified: 2015-05

Locations

CA (1)