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Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib cream
Vehicle cream
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa focused on measuring Hidradenitis suppurativa, skin disease, ruxolitinb cream

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of HS based on clinical history and physical examination for at least 3 months. Diagnosis of HS (Hurley I or II) with the following: A total AN count of 3 to ≤ 10, with no draining tunnels at screening and baseline visits. AND The AN count at the screening AND baseline visits: AN of 3 should affect at least 1 distinct anatomical area AN of > 3 to ≤ 10 should affect at least 2 distinct anatomical areas. Baseline Skin Pain or Itch NRS score ≥ 1. Agreement to NOT use topical and systemic antibiotics for treatment of HS during the study. Agreement to NOT use a diluted beach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study. Willingness to avoid pregnancy or fathering children Exclusion Criteria: Presence of draining tunnels at screening or at baseline visits. Concurrent conditions and history of other diseases: Active ongoing inflammatory diseases of the skin other than HS that might confound the evaluation of HS. Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of HS AN or compromise participant safety. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome). Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox, clinically infected AD, or impetigo) within 2 weeks before baseline. Laboratory values outside of the protocol-defined criteria. Use of any prohibited medications per protocol-defined criteria. Pregnant or lactating participants, or those considering pregnancy during the period of their study participation. Other exclusion criteria may apply.

Sites / Locations

  • Medical Dermatology Specialists Phoenix
  • First Oc Dermatology
  • Skin Care Research, Llc Scr Hollywood
  • Forcare Clinical Research
  • Marietta Dermatology the Skin Cancer Center Marietta
  • Delricht Research
  • Delricht Research
  • Beth Israel Deaconess Medical Center
  • Revival Research Institute, Llc Troy
  • Dr Bobby Buka, Md Greenwich Village
  • Dermatology Associates of Plymouth Meeting
  • International Clinical Research Tennessee Llc
  • Austin Institute For Clinical Research Aicr Pflugerville
  • Progressive Clinical Research
  • Dermatology Specialists of Spokane
  • Wiseman Dermatology Research Inc
  • Dr.Wei Jing Loo Medicine Professional Corp
  • Lynderm Research Inc
  • Skin Centre For Dermatology
  • Xlr8 Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ruxolitinib Cream

Vehicle Cream

Arm Description

Ruxolitinib 1.5% cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.

Vehicle cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.

Outcomes

Primary Outcome Measures

Change from baseline in abscess and inflammatory nodules (AN) count at Week 16.
Defined as total count of abscess and inflammatory nodules.

Secondary Outcome Measures

Proportion of participants achieving AN50
Defined as at least 50% reduction respectively in AN count relative to baseline.
Proportion of participants achieving AN75
Defined as at least 75% reduction respectively in AN count relative to baseline.
Proportion of participants achieving AN90
Defined as at least 90% reduction respectively in AN count relative to baseline.
Proportion of participants achieving AN100
Defined as 100% reduction respectively in AN count relative to baseline.
Change from baseline in the Skin Pain Numeric Rating Scale (NRS)
Defined as skin pain severity on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) in the past 24 hours.
Change from baseline in the Itch NRS score
The Itch NRS is defined as itch severity on an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch) in the past 24 hours.
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
HiSCR is defined as at least 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to baseline.
Change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) score
IHS4 score is calculated by the number of inflammatory nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4).
Number of Treatment Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

Full Information

First Posted
November 23, 2022
Last Updated
August 4, 2023
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05635838
Brief Title
Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Official Title
A Phase 2, Double-Blind, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
December 3, 2023 (Anticipated)
Study Completion Date
March 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants with Hidradenitis Suppurativa. This is a randomized 16-week double-blind, vehicle-controlled (DBVC) study followed by a 16 week open label extension period (OLE) with an active treatment for participants who complete the DBVC period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
Hidradenitis suppurativa, skin disease, ruxolitinb cream

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized 1:1 to 1 of 2 treatment groups (ruxolitinib 1.5% cream BID or vehicle cream BID).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ruxolitinib Cream
Arm Type
Experimental
Arm Description
Ruxolitinib 1.5% cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.
Arm Title
Vehicle Cream
Arm Type
Experimental
Arm Description
Vehicle cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib cream
Other Intervention Name(s)
INCB018424 cream
Intervention Description
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Intervention Type
Drug
Intervention Name(s)
Vehicle cream
Intervention Description
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Primary Outcome Measure Information:
Title
Change from baseline in abscess and inflammatory nodules (AN) count at Week 16.
Description
Defined as total count of abscess and inflammatory nodules.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Proportion of participants achieving AN50
Description
Defined as at least 50% reduction respectively in AN count relative to baseline.
Time Frame
Week 16
Title
Proportion of participants achieving AN75
Description
Defined as at least 75% reduction respectively in AN count relative to baseline.
Time Frame
Week 16
Title
Proportion of participants achieving AN90
Description
Defined as at least 90% reduction respectively in AN count relative to baseline.
Time Frame
Week 16
Title
Proportion of participants achieving AN100
Description
Defined as 100% reduction respectively in AN count relative to baseline.
Time Frame
Week 16
Title
Change from baseline in the Skin Pain Numeric Rating Scale (NRS)
Description
Defined as skin pain severity on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) in the past 24 hours.
Time Frame
Week 16
Title
Change from baseline in the Itch NRS score
Description
The Itch NRS is defined as itch severity on an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch) in the past 24 hours.
Time Frame
Week 16
Title
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)
Description
HiSCR is defined as at least 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to baseline.
Time Frame
Week 16
Title
Change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) score
Description
IHS4 score is calculated by the number of inflammatory nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4).
Time Frame
Week 16
Title
Number of Treatment Emergent Adverse Events (TEAEs)
Description
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time Frame
Up to 40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of HS based on clinical history and physical examination for at least 3 months. Diagnosis of HS (Hurley I or II) with the following: A total AN count of 3 to ≤ 10, with no draining tunnels at screening and baseline visits. AND The AN count at the screening AND baseline visits: AN of 3 should affect at least 1 distinct anatomical area AN of > 3 to ≤ 10 should affect at least 2 distinct anatomical areas. Baseline Skin Pain or Itch NRS score ≥ 1. Agreement to NOT use topical and systemic antibiotics for treatment of HS during the study. Agreement to NOT use a diluted beach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study. Willingness to avoid pregnancy or fathering children Exclusion Criteria: Presence of draining tunnels at screening or at baseline visits. Concurrent conditions and history of other diseases: Active ongoing inflammatory diseases of the skin other than HS that might confound the evaluation of HS. Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of HS AN or compromise participant safety. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome). Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox, clinically infected AD, or impetigo) within 2 weeks before baseline. Laboratory values outside of the protocol-defined criteria. Use of any prohibited medications per protocol-defined criteria. Pregnant or lactating participants, or those considering pregnancy during the period of their study participation. Other exclusion criteria may apply.
Facility Information:
Facility Name
Medical Dermatology Specialists Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
First Oc Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Skin Care Research, Llc Scr Hollywood
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Forcare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Marietta Dermatology the Skin Cancer Center Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060-1047
Country
United States
Facility Name
Delricht Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Delricht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Revival Research Institute, Llc Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Dr Bobby Buka, Md Greenwich Village
City
New York
State/Province
New York
ZIP/Postal Code
10012-1354
Country
United States
Facility Name
Dermatology Associates of Plymouth Meeting
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
International Clinical Research Tennessee Llc
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Austin Institute For Clinical Research Aicr Pflugerville
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Dermatology Specialists of Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Wiseman Dermatology Research Inc
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
Dr.Wei Jing Loo Medicine Professional Corp
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L4
Country
Canada
Facility Name
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Skin Centre For Dermatology
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 5K2
Country
Canada
Facility Name
Xlr8 Medical Research
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency

Learn more about this trial

Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

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