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History of Changes for Study: NCT03497975
PRISM Study-Pruritus Relief Through Itch Scratch Modulation (PRISM)
Latest version (submitted August 4, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 10, 2018 None (earliest Version on record)
2 August 21, 2018 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 July 15, 2019 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Status and Eligibility
4 March 18, 2020 Contacts/Locations and Study Status
5 August 4, 2020 Contacts/Locations and Study Status
6 August 19, 2020 Contacts/Locations and Study Status
7 September 17, 2020 Study Status, Contacts/Locations and Study Design
8 September 21, 2020 Contacts/Locations and Study Status
9 December 22, 2020 Contacts/Locations and Study Status
10 January 12, 2021 Study Status
11 March 25, 2021 Contacts/Locations and Study Status
12 March 26, 2021 Study Status and Eligibility
13 April 29, 2021 Contacts/Locations and Study Status
14 June 1, 2021 Contacts/Locations and Study Status
15 July 21, 2021 Study Status and Contacts/Locations
16 August 11, 2021 Contacts/Locations and Study Status
17 September 20, 2021 Contacts/Locations, Study Status and Eligibility
18 February 17, 2022 Recruitment Status, Study Status and Contacts/Locations
19 June 30, 2022 Study Status
20 August 4, 2022 Study Status
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Study NCT03497975
Submitted Date:  April 10, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: TR11
Brief Title: PRISM Study-Pruritus Relief Through Itch Scratch Modulation (PRISM)
Official Title: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm , Efficacy and Safety Study in Prurigo Nodularis (PN) With Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2018
Overall Status: Not yet recruiting
Study Start: June 2018
Primary Completion: December 2019 [Anticipated]
Study Completion: December 2020 [Anticipated]
First Submitted: March 22, 2018
First Submitted that
Met QC Criteria:
April 10, 2018
First Posted: April 13, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
April 10, 2018
Last Update Posted: April 13, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Trevi Therapeutics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: To investigate the anti-pruritic efficacy and safety of Nalbuphine ER (NAL ER) tablets in Prurigo Nodularis. Subjects will be randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, subjects who received NAL ER will continue on NAL ER and subjects who received placebo will crossover to NAL ER.
Detailed Description: This is a randomized, double-blinded, placebo-controlled, 2-arm study with an open label extension period following double-blind treatment, to investigate the anti-pruritic efficacy and safety of Nalbuphine ER tablets. Subjects will be randomized to NAL ER (2-week titration followed by 162 mg twice daily [BID] for 12 weeks) or matching placebo (14 weeks duration), with the primary endpoint evaluation at Week 14. During the open label extension, subjects who received NAL ER will continue on NAL ER total treatment duration 52 weeks including titration and subjects who received placebo will crossover to Nalbuphine ER Upon discontinuation of investigational product, all subjects will complete a 2-week off treatment Safety Follow-up Period, regardless of when and why the subject discontinued study treatment.
Open or close this module Conditions
Conditions: Prurigo Nodularis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2/Phase 3
Interventional Study Model: Crossover Assignment
Randomized, double-blinded, placebo-controlled, 2-arm study with an open label extension period following double-blind treatment.
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 240 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Active
162 mg nalbuphine ER tablets, BID
Drug: Nalbuphine ER Tablets
Active NAL ER Tablets or matching placebo
Other Names:
  • Nalbuphine matching placebo tablets
Placebo Comparator: Placebo
Matching placebo tablets
Drug: Nalbuphine ER Tablets
Active NAL ER Tablets or matching placebo
Other Names:
  • Nalbuphine matching placebo tablets
Open or close this module Outcome Measures
Primary Outcome Measures:
1. A 4 point reduction in the Worst Itch Numerical Rating Scale (WINRS) at Week 14. (Responder = at least an improvement of 4 in WINRS score)
[ Time Frame: 14 weeks ]

Comparison of percentage responders by arm;
Secondary Outcome Measures:
1. The change from baseline up to week 14 for WINRS up to Week 14
[ Time Frame: 14 weeks ]

assessment of improvement from baseline
2. The change from baseline up to week 14 for itchyQOL up to Week 14
[ Time Frame: 14 weeks ]

assessment of improvement from baseline
3. PBI-P, a simple analysis of covariance (ANCOVA) will be used to assess the change from baseline at Week 14.
[ Time Frame: 14 weeks ]

assessment of a subject's perception of their disease before and after treatment
4. PAS: 1-category improvement from baseline in lesions with excoriations.
[ Time Frame: at week 14 and at week 52 ]

Assessment of number of subjects with 1-category improvement from baseline in lesions with excoriations.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Individuals diagnosed with generalized nodular PN
  2. Severe itch due to PN
  3. Age 18 years and older at the time of consent, and a life expectancy of at least 18 months.

Exclusion Criteria:

  1. Pruritus due to localized PN (only one body part affected)
  2. Active, uncontrolled, pruritic dermatoses in need of treatment (such as atopic dermatitis, bullous pemphigoid for example) or other dermatologic conditions that in the opinion of the Investigator could confound the ability to assess PN related itch..
  3. Exposure to any investigational medication, including placebo, within 4 weeks (3 months for biologics).
Open or close this module Contacts/Locations
Central Contact Person: Clinical Ops Lead
Telephone: 2033042499
Email: clinicalops.admin@trevitherapeutics.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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