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Terminated/Withdrawn
Sponsor ID
20230053

A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

Sponsor ID
20230053
Clinicaltrials.gov ID
NCT06527404
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).

Additional Study Details

Phase
Phase 3
Product
Rocatinlimab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
469
Additional Study Details

Protocol Summary

Primary Outcome Measures

Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24

Timeframe: Up to 24 weeks

US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24

Timeframe: Up to 24 weeks

Secondary Outcome Measures

Global: Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Week 24

Timeframe: Week 24

Global: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 24

Timeframe: Baseline and Week 24

Global: Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24

Timeframe: Baseline and Week 24

Global: Number of Participants Achieving Reduction in Weekly Average Daily Prurigo Nodularis Skin Pain Assessment at Week 24 in Those with Baseline NRS Above Cutoff

Timeframe: Baseline and Week 24

US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24

Timeframe: Baseline and Week 24

US Only: Number of Participants with Improvement in Prurigo Nodularis Stage Assessment at Week 24

Timeframe: Week 24

US Only: Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24

Timeframe: Week 24

US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Skin Pain Assessment at Week 24 in Participants With Baseline Score Greater Than or Equal to a Cutoff Score

Timeframe: Week 24

Change from Baseline in Weekly Average of Daily Itch Score at Weeks 24, 36 and 52

Timeframe: Baseline, Week 24, Week 36 and Week 52

Percent Improvement from Baseline in Weekly Average of Daily Itch Score at Week 36 and 52

Timeframe: Baseline, Week 36 and Week 52

Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Weeks 16, 36 and 52

Timeframe: Baseline, Week 16, Week 36 and Week 52

Number of Participants Achieving Weekly Average of Daily Itch Score Less than a Cutoff Score at Week 36 and 52

Timeframe: Week 36 and Week 52

Change from Baseline in Prurigo Nodularis Stage Assessment Score at Week 24, 36, and 52

Timeframe: Baseline, Week 24, Week 36 and Week 52

Number of Participants Achieving Improvement in Prurigo Nodularis Stage Assessment Score at Weeks 36 and 52

Timeframe: Week 36 and Week 52

Number of Participants Achieving Improvement in Prurigo Nodularis Activity Assessment Score at Weeks 24, 36 and 52

Timeframe: Week 24, Week 36 and Week 52

Change from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52

Timeframe: Baseline, Week 24, Week 36 and Week 52

Number of Participants Achieving Reduction from Baseline in Quality of Life Assessment Score at Weeks 24, 36 and 52 in Participants with Baseline Score Greater Than or Equal to a Cutoff Score

Timeframe: Baseline, Week 24, Week 36 and Week 52

Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Weeks 24, 36 and 52

Timeframe: Baseline, Week 24, Week 36 and Week 52

Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52

Timeframe: Baseline, Week 24, Week 36 and Week 52

Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Weeks 24, 36 and 52 in Participants with Baseline Weekly Average Score Greater Than or Equal to a Cutoff Score

Timeframe: Baseline, Week 24, Week 36 and Week 52

Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Stage Assessment at Week 36 and 52

Timeframe: Baseline, Week 36 and Week 52

Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Week 36 and 52 in Participants With Baseline Score Greater Than or Equal to a Cutoff Score

Timeframe: Baseline, Week 36 and Week 52

Locations

Location
Status
Contact Us
Location
Direct Helpers Research Center
Hialeah, FL, United States, 33012
Status
Recruiting
Location
Los Angeles Universal Research Center
Los Angeles, CA, United States, 90057
Status
Recruiting
Location
Center For Clinical Studies PLLC
Houston, TX, United States, 77004
Status
Recruiting
Location
Clinical Research Trials of Florida Inc
Tampa, FL, United States, 33607
Status
Recruiting
Location
Wolverine Clinical Trials
Santa Ana, CA, United States, 92706
Status
Recruiting
Location
Optima Research
Boardman, OH, United States, 44512
Status
Recruiting
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Study Info
Age
18 - 100 Years
Condition
  • Prurigo Nodularis
    • Sex
    All
    Trial Dates
    Jul 2024 - Apr 2026
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Age ≥ 18 years (or any legal adult age within the country if it is older than 18 years) • Clinical Diagnosis of Prurigo Nodularis that has been present for at least 3 months. • Patient-reported average Daily Itch Score based on electronic daily diary assessment the last 7 days prior to and including day 1. • Has ≥ 20 prurigo nodularis nodules in total with bilateral distribution on both legs and /or arms and /or trunk. • History of inadequate response to topical therapies of medium or higher potency or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
    Exclusion Criteria:
    • Skin or systemic morbidities, other than prurigo nodularis, that have been active within the last 3 months that interfere with assessment of study outcomes including but not limited to atopic dermatitis (signs or symptoms other than dry skin or requiring treatment is not allowed; use of emollients and/or history of AD is allowed). • Prurigo nodularis secondary to medications. • Prurigo nodularis secondary to neurologic or psychiatric medical conditions. • Treatment with any systemic biologic immunosuppressive or systemic biologic immunomodulatory therapy for prurigo nodularis or any other autoimmune, inflammatory, or allergic disease within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 prerandomization. • Treatment with live virus including live attenuated vaccination 12 weeks prior to day 1 prerandomization.