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Safety, Tolerability and Efficacy of SNA-120 for Treatment of Pruritus and Psoriasis in Subjects Treated With Calcipotriene

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ClinicalTrials.gov Identifier: NCT03448081
Recruitment Status : Active, not recruiting
First Posted : February 27, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sienna Labs ( Sienna Biopharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Pruritus Psoriasis Drug: SNA-120 Drug: Placebo Drug: Calcipotriene Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 12, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching Psoriasis

Arm Intervention/treatment
Active Comparator: SNA-120 + Calcipotriene Drug: SNA-120
SNA-120 (0.5%) active ointment

Drug: Calcipotriene
Calcipotriene ointment (0.005%)

Placebo Comparator: Placebo + Calcipotriene Drug: Placebo
Vehicle Ointment

Drug: Calcipotriene
Calcipotriene ointment (0.005%)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Change in Investigator Global Assessment (IGA) from baseline [ Time Frame: week 8 ]
    5-point scale used to assess the overall severity of psoriasis by evaluting induration, erythema and desquamation (0=clear to 4=severe)

  2. Change in Psoriasis Area Severity Index (PASI) from baseline [ Time Frame: week 8 ]
    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)


Other Outcome Measures:
  1. Safety measured by frequency of Adverse Events [ Time Frame: week 10 ]
    Frequency of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10

  2. Safety measured by severity of Adverse Events [ Time Frame: week 10 ]
    Severity of all Adverse Events (AEs), including local site reactions that occur during the trial from baseline through week 10

  3. Safety measured by change in clinical lab results from baseline [ Time Frame: week 10 ]
    biochemistry lab assessments

  4. Safety measured by change in clinical lab results from baseline [ Time Frame: week 10 ]
    Clinical laboratory assessments include urinalysis (pH, glucose, protein)

  5. Safety measured by change in clinical lab results from baseline [ Time Frame: week 10 ]
    hematology lab assessments

  6. Safety measured by change from baseline in blood pressure [ Time Frame: week 10 ]
    Systolic/diastolic blood pressure (BP in mmHg) - measured every full clinic visit, from baseline through week 10

  7. Safety measured by change from baseline in pulse [ Time Frame: week 10 ]
    Measured in beats per minute (bpm) - measured every full clinic visit, from baseline through week 10

  8. Safety measured by number of abnormal physical examinations from baseline [ Time Frame: week 8 ]
  9. Safety measured by PR/PQ intervals measured by 12-lead ECG [ Time Frame: week -4 ]
    Safety measured by PR/PQ intervals measured by 12-lead ECG at screening

  10. Safety measured by PR/PQ intervals measured by 12-lead ECG [ Time Frame: week 0 ]
    Safety measured by PR/PQ intervals measured by 12-lead ECG at baseline

  11. Safety measured by PR/PQ intervals measured by 12-lead ECG [ Time Frame: week 4 ]
    Safety measured by PR/PQ intervals measured by 12-lead ECG at week 4

  12. Safety measured by PR/PQ intervals measured by 12-lead ECG [ Time Frame: week 8 ]
    Safety measured by PR/PQ intervals measured by 12-lead ECG at week 8

  13. Safety measured by QRS duration measured by 12-lead ECG [ Time Frame: week -4 ]
    Safety measured by QRS duration measured by 12-lead ECG at screening

  14. Safety measured by QRS duration measured by 12-lead ECG [ Time Frame: week 0 ]
    Safety measured by QRS duration measured by 12-lead ECG at baseline

  15. Safety measured by QRS duration measured by 12-lead ECG [ Time Frame: week 4 ]
    Safety measured by QRS duration measured by 12-lead ECG at week 4

  16. Safety measured by QRS duration measured by 12-lead ECG [ Time Frame: week 8 ]
    Safety measured by QRS duration measured by 12-lead ECG at week 8

  17. Safety measured by QT intervals measured by 12-lead ECG [ Time Frame: week -4 ]
    Safety measured by QT intervals measured by 12-lead ECG at screening

  18. Safety measured by QT intervals measured by 12-lead ECG [ Time Frame: week 0 ]
    Safety measured by QT intervals measured by 12-lead ECG at baseline

  19. Safety measured by QT intervals measured by 12-lead ECG [ Time Frame: week 4 ]
    Safety measured by QT intervals measured by 12-lead ECG at week 4

  20. Safety measured by QT intervals measured by 12-lead ECG [ Time Frame: week 8 ]
    Safety measured by QT intervals measured by 12-lead ECG at week 8



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448081


Locations
United States, Alabama
Sienna 018
Anniston, Alabama, United States, 36207
Sienna 009
Mobile, Alabama, United States, 36608
United States, California
Sienna 019
Fountain Valley, California, United States, 92708
Sienna 007
Los Angeles, California, United States, 90045
Site 016
Sherman Oaks, California, United States, 91403
United States, Florida
Site 013
Coral Gables, Florida, United States, 33143
Site 015
Sanford, Florida, United States, 32771
United States, Indiana
Site 012
Indianapolis, Indiana, United States, 46256
United States, Michigan
Sienna 011
Warren, Michigan, United States, 48088
United States, New Jersey
Sienna 005
Berlin, New Jersey, United States, 08009
United States, New York
Sienna 020
Rochester, New York, United States, 14623
United States, North Carolina
Site 014
Raleigh, North Carolina, United States, 27612
United States, Oklahoma
Sienna 002
Oklahoma City, Oklahoma, United States, 73118
United States, Texas
Sienna 017
Austin, Texas, United States, 78745
Sienna 010
Houston, Texas, United States, 77004
Sienna 021
Pflugerville, Texas, United States, 78660
Sienna 001
San Antonio, Texas, United States, 78213
Canada, British Columbia
Sienna 006
Surrey, British Columbia, Canada, V3R 6A7
Canada, Ontario
Sienna 008
Peterborough, Ontario, Canada, K9J 5K2
Canada, Quebec
Sienna 003
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Sienna Biopharmaceuticals

Responsible Party: Sienna Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT03448081     History of Changes
Other Study ID Numbers: SNA-120-202
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Pruritus
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Skin Manifestations
Signs and Symptoms
Calcipotriene
Calcitriol
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents