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.

  • STATUS
    Recruiting
Updated on 23 November 2020
topical agents
calcipotriene
plaque psoriasis

Summary

This study is being done to evaluate the safety and tolerability of SNA-120 0.5% ointment applied with calcipotriene 0.005% ointment. This study will also evaluate the efficacy (effectiveness) of SNA-120 0.5% ointment applied with calcipotriene 0.005% ointment in the treatment of psoriasis and the associated symptoms of itching. The results will be compared against a vehicle. The vehicle is a moisturizing ointment that looks like the SNA-120 but does not contain an active ingredient. 

SNA-120 is an experimental drug, which means it is not yet approved by Health Canada or the United States (US) Food and Drug Administration. It is not approved for use outside of studies like this one. The active ingredient of SNA-120 ointment may inhibit itching in psoriasis patients. Calcipotriene ointment is marketed in the United States for the treatment of plaque psoriasis. You will receive it as if your regular doctor would have prescribed it to you outside this research study.  

There is a 50% chance of having the vehicle ointment instead of the SNA-120 ointment. For this study, a mandatory blood collection will be performed.

The financial compensation for study related expenses will be up to $760.00 if all visits are completed.

The study will last a period of up to 19 weeks. There will be 8 on site visits whose duration will vary from 1-3 hours long and 2 phone call visits of approximately 15-30 minutes.

Description

The study staff at Center for Clinical Studies is available to answer any questions you have regarding this study. To learn more or to see if you qualify, please call us at 281-333-2288, select option 2. COMPENSATION All study tests, examinations, and medical care required as part of this study are provided at no cost to you, the public health plan (for Canadian residents), or your private medical insurance (if any). POTENTIAL BENEFITS OF PARTICIPATING IN THE STUDY You should not expect any benefit from taking part in this study. Your condition may get better, stay the same, or get worse. You may benefit from the medical monitoring (e.g. physical examination, laboratory tests) that is part of the study. The information from this study may help our understanding of the safety of SNA-120 and its potential effectiveness in subjects with psoriasis. This may contribute to the advancement of knowledge in the field of dermatology. If you take part in this study, other people with psoriasis may be helped. INFORMATION ABOUT THE STUDY Sienna Biopharmaceuticals Inc. is sponsoring this study. This study will be performed in 4 parts: Screening, Part A, Part B and Follow-up. This study will enroll approximately 86 adult subjects with psoriasis into Part A of the study, and approximately 60 adult subjects into Part B. Approximately 10 centers in United States and Canada will participate.

Details
Condition Pruritus, Dermatology, Psoriasis
Clinical Study IdentifierTX207225
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women ages 18 and older
A clinical diagnosis of stable psoriasis for at least 6 months prior to screening
Chronic pruritus of the psoriasis plaques to be present for at least 6 weeks prior to screening
Meet score criteria for Pruritus (itch)
Willing and able to undergo a 4-week period with calcipotriene ointment twice-daily dosing and remain on this stable regimen throughout the study
Meet score criteria for mild to moderate psoriasis affecting 1% to 15% of the BSA (body surface area), excluding the face, palms, and soles
Psoriasis plaques are amenable to treatment with a topical medication
Willing and able to comply with the study instructions, complete study diary, and attend all scheduled visits
Willing and able to discontinue all other topical products to treat psoriasis and/or itch, including topical steroids
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
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
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

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)
Current or past history of hypercalcemia, Vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
Laboratory test results indicating active or chronic hepatitis infection
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)
Subjects with spontaneously improving or rapidly deteriorating psoriasis and/or pruritus before screening
Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis
Subjects with a clinical diagnosis of bacterial infection of the skin including impetigo and abscesses
Subjects who have previously failed treatment with or failed to tolerate treatment with calcipotriene
The use of certain medications/ treatments which the study staff will review and discuss before screening
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.)
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
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
Currently enrolled in an investigational drug or device study or has used an investigational drug or an investigational device treatment within 30 days
Women who are pregnant or lactating, or are planning to become pregnant during the study
Subjects previously participating in any SNA-120 (and/or CT327) clinical studies
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