PruritusPhase 2NCT03448081
Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene
A Phase 2 study testing SNA-120 and Calcipotriene in people with Pruritus and Psoriasis, run by Sienna Biopharmaceuticals at 20 sites in 2 countries.
Trial summary
A Phase 2 study evaluating safety, tolerability, and efficacy of SNA-120 ointment when administered topically with calcipotriene ointment for the treatment of pruritus and psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SNA-120 and Calcipotriene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 12 Feb 2018to 10 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Stable psoriasis for at least 6 months prior to screening
- Chronic pruritus of the psoriasis plaques at least 6 weeks prior to screening
- At least moderate baseline overall itch associated with psoriatic plaques
- Willing and able to undergo a 4-week run-in with calcipotriene ointment dosing and remain on this stable regimen throughout the study
- Mild or moderate psoriasis at screening and baseline
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- Subject's plaques are amenable to treatment with a topical medication
- 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 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
Who cannot join
- Underlying conditions other than psoriasis that, in the opinion of the investigator, currently cause or influence pruritus of the overall skin
- Current or past history of hypercalcemia, Vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
- Thyroid abnormalities that, in the opinion of the investigator, are clinically relevant and may affect assessments
- Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis
- Subjects with a clinical diagnosis of bacterial infection of the skin
- Subjects who have previously failed treatment with or failed to tolerate treatment with calcipotriene
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- Known hypersensitivity to SNA-120 (pegcantratinib), 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 or 5 half-lives of investigational drug (whichever is longer) of baseline
- 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 or pegcantratinib) clinical studies
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States17 sites
Sienna 018
Anniston, Alabama, 36207
Sienna 017
Austin, Texas, 78745
Sienna 005
Berlin, New Jersey, 08009
Site 013
Coral Gables, Florida, 33143
Sienna 019
Fountain Valley, California, 92708
Sienna 010
Houston, Texas, 77004
Site 012
Indianapolis, Indiana, 46256
Sienna 007
Los Angeles, California, 90045
Sienna 009
Mobile, Alabama, 36608
Sienna 002
Oklahoma City, Oklahoma, 73118
Sienna 021
Pflugerville, Texas, 78660
Site 014
Raleigh, North Carolina, 27612
Sienna 020
Rochester, New York, 14623
Sienna 001
San Antonio, Texas, 78213
Site 015
Sanford, Florida, 32771
Site 016
Sherman Oaks, California, 91403
Sienna 011
Warren, Michigan, 48088
Canada3 sites
Sienna 003
Montreal, Quebec, H2K 4L5
Sienna 008
Peterborough, Ontario, K9J 5K2
Sienna 006
Surrey, British Columbia, V3R 6A7
About this study
Official title: An Exploratory, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of SNA-120 (Pegcantratinib) Ointment for the Symptomatic Treatment of Persistent Pruritus and Psoriasis in Subjects Being Treated With Calcipotriene Ointment
A Phase 2 study evaluating safety, tolerability, and efficacy of SNA-120 ointment when administered topically with calcipotriene ointment for the treatment of pruritus and psoriasis.
Read the detailed description
All subjects are required to meet eligibility requirements and undergo a calcipotriene run-in period (Part A) prior to qualifying and randomizing into the study to receive either SNA-120 or Placebo ointment in combination with calcipotriene ointment (Part B). Combination therapy (SNA-120 ointment + calcipotriene ointment or Placebo ointment + calcipotriene ointment) is to continue over an 8 week period to evaluate safety, tolerability and the efficacy of treatment on both persistent pruritus and the visible signs and symptoms of psoriasis.
- Being tested
- SNA-120, Placebo, Calcipotriene
- Medical subject headings
- Pruritus, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNA-120Drug
SNA-120 (0.5%) active ointment
PlaceboDrug
Vehicle Ointment
CalcipotrieneDrug
Calcipotriene ointment (0.005%)
| Study group | Role | What they receive |
|---|---|---|
| SNA-120 + Calcipotriene | Active comparator | Not described Receives: Drug: SNA-120; Drug: Calcipotriene |
| Placebo + Calcipotriene | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Calcipotriene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Itch Numeric Rating Scale scores (I-NRS) from baseline
11-point NRS scale used to assess pruritus severity, ranging from 0 (no itching at all) to 10 (worst possible itching)
Measured: week 8
Secondary outcomes (2)
Change in Investigator Global Assessment (IGA) from baseline
5-point scale used to assess the overall severity of psoriasis by evaluting induration, erythema and desquamation (0=clear to 4=severe)
Measured: week 8
Change in Psoriasis Area Severity Index (PASI) from baseline
A quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance (0 = no disease to 72 = maximum disease)
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start12 Feb 2018
- Primary completion21 Nov 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sienna Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448081
- Sponsor's protocol ID
- SNA-120-202
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2018
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of SNA-120 (Pegcantratinib) Ointment for the Symptomatic Treatment of Persistent Pruritus and Psoriasis in Subjects Being Treated With Calcipotriene Ointment
- ClinicalTrials.gov ID
- NCT03448081
- Acronym / sponsor ID
- SNA-120-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Sienna BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 study evaluating safety, tolerability, and efficacy of SNA-120 ointment when administered topically with calcipotriene ointment for the treatment of pruritus and psoriasis.
Detailed description
All subjects are required to meet eligibility requirements and undergo a calcipotriene run-in period (Part A) prior to qualifying and randomizing into the study to receive either SNA-120 or Placebo ointment in combination with calcipotriene ointment (Part B). Combination therapy (SNA-120 ointment + calcipotriene ointment or Placebo ointment + calcipotriene ointment) is to continue over an 8 week period to evaluate safety, tolerability and the efficacy of treatment on both persistent pruritus and the visible signs and symptoms of psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNA-120 + Calcipotriene | Active comparator | Drug: SNA-120, Drug: Calcipotriene |
| Placebo + Calcipotriene | Placebo comparator | Drug: Placebo, Drug: Calcipotriene |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent
- Stable psoriasis for at least 6 months prior to screening
- Chronic pruritus of the psoriasis plaques at least 6 weeks prior to screening
- At least moderate baseline overall itch associated with psoriatic plaques
- Willing and able to undergo a 4-week run-in with calcipotriene ointment dosing and remain on this stable regimen throughout the study
Key exclusion criteria (10 listed)
- Underlying conditions other than psoriasis that, in the opinion of the investigator, currently cause or influence pruritus of the overall skin
- Current or past history of hypercalcemia, Vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders
- Thyroid abnormalities that, in the opinion of the investigator, are clinically relevant and may affect assessments
- Current diagnosis of guttate, erythrodermic, exfoliative, or pustular psoriasis
- Subjects with a clinical diagnosis of bacterial infection of the skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNA-120SNA-120 (0.5%) active ointment | Drug | SNA-120 + Calcipotriene |
| PlaceboVehicle Ointment | Drug | Placebo + Calcipotriene |
| CalcipotrieneCalcipotriene ointment (0.005%) | Drug | Placebo + Calcipotriene, SNA-120 + Calcipotriene |
Primary outcome
Change in Itch Numeric Rating Scale scores (I-NRS) from baseline
Time frame: week 8
11-point NRS scale used to assess pruritus severity, ranging from 0 (no itching at all) to 10 (worst possible itching)
2 secondary outcomes
Change in Investigator Global Assessment (IGA) from baseline
Time frame: week 8
Change in Psoriasis Area Severity Index (PASI) from baseline
Time frame: week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNA-120 and Calcipotriene in people with Pruritus and Psoriasis, run by Sienna Biopharmaceuticals at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Itch Numeric Rating Scale scores (I-NRS) from baseline (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.