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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06855498




Registration number
NCT06855498
Ethics application status
Date submitted
26/02/2025
Date registered
3/03/2025

Titles & IDs
Public title
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Scientific title
A Phase 3b, Multicenter, Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Secondary ID [1] 0 0
INCB054707-801
Universal Trial Number (UTN)
Trial acronym
STOP-LTR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis Suppurativa (HS) 0 0
Condition category
Condition code

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

Experimental: povorcitinib - Participants will receive povorcitinib treatment with the same schedule and dose options as the study in which they originally enrolled.


Treatment: Drugs: povorcitinib
Study drug will be taken orally as defined by the protocol.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit
Timepoint [1] 0 0
Up to approximately 3 years

Eligibility
Key inclusion criteria
* Ability to comprehend and willingness to sign a written ICF for the study.
* Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment.
* Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator.
* Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
* Willingness to avoid pregnancy or fathering children as defined in the protocol.
* Willingness and ability to comply with the study Protocol and procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Had been permanently discontinued from study treatment during the parent study.
* Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study.
* Received at least 1 dose of either of the following therapies within the 28 days prior to starting treatment in this rollover study:

* Biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab).
* Live, attenuated vaccine.
* Plans for administration of a live, attenuated vaccine during this study or within 8 weeks after the last dose of study drug.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class.
* Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Any condition that would, in the investigator's and/or sponsor's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
28/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2028
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigative Site AU003 - Kogarah
Recruitment hospital [2] 0 0
Investigative Site AU005 - Liverpool
Recruitment hospital [3] 0 0
Investigative Site AU001 - Newcastle
Recruitment hospital [4] 0 0
Investigative Site AU007 - Wolloongabba
Recruitment hospital [5] 0 0
Investigative Site AU006 - Woolloongabba
Recruitment hospital [6] 0 0
Investigative Site AU004 - Carlton
Recruitment hospital [7] 0 0
Investigative Site AU002 - East Melbourne
Recruitment hospital [8] 0 0
Investigative Site AU008 - Fremantle
Recruitment hospital [9] 0 0
Investigative Site AU009 - Westmead
Recruitment postcode(s) [1] 0 0
02217 - Kogarah
Recruitment postcode(s) [2] 0 0
02170 - Liverpool
Recruitment postcode(s) [3] 0 0
02289 - Newcastle
Recruitment postcode(s) [4] 0 0
04102 - Wolloongabba
Recruitment postcode(s) [5] 0 0
04102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
03053 - Carlton
Recruitment postcode(s) [7] 0 0
03002 - East Melbourne
Recruitment postcode(s) [8] 0 0
06160 - Fremantle
Recruitment postcode(s) [9] 0 0
02145 - Westmead
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Incyte Medical Monitor
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Incyte Corporation Call Center (US)
Address 0 0
Country 0 0
Phone 0 0
1.855.463.3463
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/NCT06855498