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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
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
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
Number of Participants Achieving Reduction from Baseline in Weekly Average of Daily Itch Score at Week 16
Timepoint [5] 0 0
Baseline and Week 16
Secondary outcome [6] 0 0
Number of Participants Achieving Improvement in Prurigo Nodularis Assessment Score at Week 16
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Change from Baseline in Weekly Average of Daily Itch Score at Week 24
Timepoint [7] 0 0
Baseline and Week 24
Secondary outcome [8] 0 0
Change from Baseline in Prurigo Nodularis Assessment Score at Week 24
Timepoint [8] 0 0
Baseline and Week 24
Secondary outcome [9] 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 [9] 0 0
Baseline and Week 24
Secondary outcome [10] 0 0
Change from Baseline in Quality of Life Assessment Score at Week 24
Timepoint [10] 0 0
Baseline and Week 24
Secondary outcome [11] 0 0
Change from Baseline in Quality of Life Assessment Score at Week 16
Timepoint [11] 0 0
Baseline and week 16
Secondary outcome [12] 0 0
Change from Baseline in Weekly Average of Daily Skin Pain Assessment Score at Week 24
Timepoint [12] 0 0
Baseline and Week 24
Secondary outcome [13] 0 0
Change from Baseline in Weekly Average of Daily Sleep Disturbance Assessment Score at Week 24
Timepoint [13] 0 0
Baseline and Week 24
Secondary outcome [14] 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 [14] 0 0
Baseline and week 24
Secondary outcome [15] 0 0
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [15] 0 0
Up to approximately Week 68
Secondary outcome [16] 0 0
Number of Participants Experiencing AEs of Special Interest (EOIs)
Timepoint [16] 0 0
Up to approximately Week 68
Secondary outcome [17] 0 0
Number of Participants with Anti-rocatinlimab Antibodies
Timepoint [17] 0 0
Baseline to Week 68
Secondary outcome [18] 0 0
Serum Concentrations of Rocatinlimab
Timepoint [18] 0 0
Baseline to Week 52
Secondary outcome [19] 0 0
Trough Concentration (Ctrough) of Rocatinlimab
Timepoint [19] 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 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 1prerandomization.
* 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
15/05/2027
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 postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Japan
State/province [12] 0 0
Toyama
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Ansansi, Gyeonggido
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Turkey
State/province [15] 0 0
Ankara
Country [16] 0 0
Turkey
State/province [16] 0 0
Aydin
Country [17] 0 0
Turkey
State/province [17] 0 0
Denizli
Country [18] 0 0
Turkey
State/province [18] 0 0
Gaziantep
Country [19] 0 0
Turkey
State/province [19] 0 0
Samsun

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
medinfo@amgen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


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