Last updated on October 2019

This is an Exploratory Study to Evaluate the Safety, Tolerability, and Efficacy of SNA-120 (Pegcantratinib) Ointment for the Symptomatic Treatment of Persistent Pruritus (Itch) and Psoriasis in Subjects Being Treated with Calcipotriene Ointment.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pruritus | Itch | Dermatology | Psoriasis | Psoriasis and Psoriatic Disorders | Calcipotriene
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion criteria (additional criteria not listed may apply):

  1. Men and women ages 18 and older
  2. A clinical diagnosis of stable psoriasis for at least 6 months prior to screening
  3. Chronic pruritus of the psoriasis plaques to be present for at least 6 weeks prior to screening
  4. Meet score criteria for Pruritus (itch)
  5. Willing and able to undergo a 4-week period with calcipotriene ointment twice-daily dosing and remain on this stable regimen throughout the study
  6. Meet score criteria for mild to moderate psoriasis affecting 1% to 15% of the BSA (body surface area), excluding the face, palms, and soles
  7. Psoriasis plaques are amenable to treatment with a topical medication
  8. Willing and able to comply with the study instructions, complete study diary, and attend all scheduled visits
  9. Willing and able to discontinue all other topical products to treat psoriasis and/or itch, including topical steroids
  10. Willing and able to avoid prolonged exposure of the designated treatment plaques to ultraviolet (UV) radiation (natural and artificial) for the duration of the study
  11. Women of childbearing potential must have a negative pregnancy test at screening and Part B baseline before randomization (Study Day B1) and must agree to use highly effective methods of contraception during the study
  12. Men who engage in sexual activity that can result in fathering children must agree to use highly effective forms of contraception during the study

Exclusion Criteria (additional criteria not listed may apply):

  1. Underlying conditions other than psoriasis that, in the opinion of the investigator, currently cause or influence pruritus of the overall skin, including pruritus that is not associated with psoriasis (e.g. significant xerosis, drug-induced pruritus, renal insufficiency, or liver dysfunction)
  2. Current or past history of hypercalcemia, Vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
  3. Laboratory test results indicating active or chronic hepatitis infection
  4. Thyroid abnormalities that, in the opinion of the investigator, are clinically relevant and may affect assessments, (ie, uncontrolled hyper- or hypothyroidism that may impact itching)
  5. Subjects with spontaneously improving or rapidly deteriorating psoriasis and/or pruritus before screening
  6. Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis
  7. Subjects with a clinical diagnosis of bacterial infection of the skin including impetigo and abscesses
  8. Subjects who have previously failed treatment with or failed to tolerate treatment with calcipotriene
  9. The use of certain medications/ treatments which the study staff will review and discuss before screening
  10. A history of any major medical illness or clinically significant illness that may influence subject safety and/or the study outcome (e.g. active malignancy, HIV, etc.)
  11. Subjects who, in the opinion of the investigator, have any acute or chronic medical or psychiatric condition or laboratory abnormality at screening that would make them unsuitable for participation in this study or that places the subject at undue risk (e.g. history of drug, alcohol, or other substance abuse) or other factors limiting the ability of the subject to cooperate and to comply with this protocol
  12. Known hypersensitivity to SNA-120, calcipotriene, the study treatment excipients, and /or polyethylene glycol (PEG), or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation
  13. Currently enrolled in an investigational drug or device study or has used an investigational drug or an investigational device treatment within 30 days
  14. Women who are pregnant or lactating, or are planning to become pregnant during the study
  15. Subjects previously participating in any SNA-120 (and/or CT327) clinical studies

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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