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

Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435342
• Other study ID #: 186-03
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2015
• Last updated: May 1, 2015
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Kineta Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Canada	Innovaderm Research, Inc	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Kineta Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Subjects with adverse events		From randomization through Day 57 (12 timepoints)	Yes
Secondary	Target lesion assessment	Target lesion evaluated for erythema, induration, and scaling.	From randomization to Day 57 (4 timepoints)	No
Secondary	Psoriasis Area Severity Index (PASI) score		From randomization to Day 57 (4 timepoints)	No
Secondary	Patient and Investigator Global Assessment of Psoriasis		From randomization to Day 57 (4 timepoints)	No
Secondary	Psoriasis Disability Index (PDI)		From randomization to Day 57 (4 timepoints)	No
Secondary	Skin biomarker assessments	Skin biopsy from psoriatic lesion collected for analysis of gene expression via qPCR and immune cell infiltration via histology and immunohistochemistry analysis.	From randomaization to Day 32 (2 timepoints)	No
Secondary	Blood biomarker assessments	Blood collected for analysis of gene and protein expression as well as immunophenotyping of T cell subsets.	From randomizatoin to Day 57 (5 timepoints)	No
Secondary	Dermatology Quality of Life Questionnaire (DLQI)		From randomization to Day 57 (4 timepoints)	No
Secondary	Presence of specific anti-drug antibodies to dalazatide	Serum evaluated for specific anti-drug antibody using ELISA-based immunoassay.	From randomization to Day 57 (three timepoints)	No
Secondary	Subjects with changes in vital signs	Vital signs include temperature, respiratory rate, supine blood pressure and pulse.	From randomization to Day 57 (12 timepoints)	Yes
Secondary	Subjects with changes in symptom-directed physical examinations		From randomization to day 5 (12 timepoints)	Yes