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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06527404




Registration number
NCT06527404
Ethics application status
Date submitted
23/07/2024
Date registered
30/07/2024

Titles & IDs
Public title
A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
Scientific title
A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who Are Inadequately Controlled on Topical Therapies or Not Eligible for Topical Therapies
Secondary ID [1] 0 0
20230053
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prurigo Nodularis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rocatinlimab
Treatment: Drugs - Placebo

Experimental: Arm A: Blinded Treatment - Participants will receive rocatinlimab dose 1 subcutaneously (SC) during Treatment Period A and B.

Experimental: Arm B: Blinded Treatment - Participants will receive rocatinlimab dose 2 SC during Treatment Period A and B.

Experimental: Arm C: Blinded Treatment - Participants will receive matching placebo SC during Treatment Period A and B.

Experimental: Arm D: Open-label - Participants will receive open-label rocatinlimab dose 1 SC during Treatment Period B.


Treatment: Drugs: Rocatinlimab
SC Injection

Treatment: Drugs: Placebo
SC Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
Timepoint [1] 0 0
Up to 24 weeks
Primary outcome [2] 0 0
US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score and Prurigo Nodularis Assessment at Week 24
Timepoint [2] 0 0
Up to 24 weeks
Secondary outcome [1] 0 0
Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 24
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Global: Percentage Improvement from Baseline in Weekly Average of Daily Itch Score at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
US Only: Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 24
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
US Only: Number of Participants with Improvement in Prurigo Nodularis Assessment at Week 24
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 16
Timepoint [6] 0 0
Baseline and Week 16
Secondary outcome [7] 0 0
Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 16
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
Change from Baseline in Weekly Average of Daily Itch Score at Week 24
Timepoint [8] 0 0
Baseline and Week 24
Secondary outcome [9] 0 0
Change from Baseline in Prurigo Nodularis Assessment Score at Week 24
Timepoint [9] 0 0
Baseline and Week 24
Secondary outcome [10] 0 0
Number of Participants Achieving Reduction from Baseline in Quality of Life Assessment Score at Week 24 in Participants with Baseline Score Greater Than a Cutoff Score
Timepoint [10] 0 0
Baseline and Week 24
Secondary outcome [11] 0 0
Change from Baseline in Quality of Life Assessment Score at Week 24
Timepoint [11] 0 0
Baseline and Week 24
Secondary outcome [12] 0 0
Change from Baseline in Quality of Life Assessment Score at Week 16
Timepoint [12] 0 0
Baseline and week 16
Secondary outcome [13] 0 0
Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Week 24
Timepoint [13] 0 0
Baseline and Week 24
Secondary outcome [14] 0 0
Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Week 24
Timepoint [14] 0 0
Baseline and Week 24
Secondary outcome [15] 0 0
Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Week 24 in Participants with Baseline Weekly Average Score Greater Than a Cutoff Score
Timepoint [15] 0 0
Baseline and week 24
Secondary outcome [16] 0 0
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [16] 0 0
Up to approximately Week 68
Secondary outcome [17] 0 0
Number of Participants Experiencing AEs of Special Interest (EOIs)
Timepoint [17] 0 0
Up to approximately Week 68
Secondary outcome [18] 0 0
Number of Participants with Anti-rocatinlimab Antibodies
Timepoint [18] 0 0
Baseline to Week 68
Secondary outcome [19] 0 0
Serum Concentrations of Rocatinlimab
Timepoint [19] 0 0
Baseline to Week 52
Secondary outcome [20] 0 0
Trough Concentration (Ctrough) of Rocatinlimab
Timepoint [20] 0 0
Baseline to Week 52

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/05/2027
Actual
Sample size
Target
460
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St George Dermatology and Skin Cancer Centre - Kogarah
Recruitment hospital [2] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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United States of America
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Florida
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Michigan
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Texas
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United States of America
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Utah
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Argentina
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Córdoba
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Argentina
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Distrito Federal
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Argentina
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Tucuman
Country [16] 0 0
Argentina
State/province [16] 0 0
Mendoza
Country [17] 0 0
Austria
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Graz
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Belgium
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Bruxelles
Country [19] 0 0
Belgium
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Leuven
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Belgium
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Liege
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British Columbia
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Canada
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Ontario
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Chile
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Remscheid
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Canarias
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Madrid
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London
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Waltham Abbey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06527404