Clinical trial NCT02435342 (phase 1, status: completed)
Conditions: plaque psoriasis
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50
Drugs: dalazatide, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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.