NCT05635838

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

Completed Phase 2 Results posted Last updated 1 November 2024

What this trial tests

Phase 2 trial testing Ruxolitinib cream in Hidradenitis Suppurativa in 69 participants. Completed in 14 March 2024.

Timeline

7 December 2022

Primary endpoint
19 October 2023

14 March 2024

Quick facts

Lead sponsor	Incyte Corporation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	69
Start date	7 December 2022
Primary completion	19 October 2023
Estimated completion	14 March 2024
Sites	20 locations across Canada, United States

Drugs / interventions tested

• Ruxolitinib cream — full drug profile →
• Vehicle cream — full drug profile →

Conditions studied

• Hidradenitis Suppurativa — all drugs for Hidradenitis Suppurativa →

Sponsor

Incyte Corporation — full company profile →

Who can join

18 and older, any sex, with Hidradenitis Suppurativa. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 Primary · Baseline; Week 16

The mixed model repeated measure (MMRM) included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.

Group	Value	95% CI
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID	-3.61	± 0.378
DBVC Period: Vehicle Cream BID	-2.42	± 0.336

Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 Secondary · Baseline; Week 16

AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, in AN count relative to Baseline.

AN50

Group	Value	95% CI
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID	79.2
DBVC Period: Vehicle Cream BID	56.3

AN75

Group	Value	95% CI
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID	54.2
DBVC Period: Vehicle Cream BID	25.0

AN90

Group	Value	95% CI
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID	20.8
DBVC Period: Vehicle Cream BID	12.5

AN100

Group	Value	95% CI
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID	20.8
DBVC Period: Vehicle Cream BID	12.5

Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline Secondary · Baseline; Week 16

Pre-existing ANs at Baseline were defined as abscesses and/or inflammatory nodules present at Baseline. All new ANs identified during the study in an anatomical area that had pre-existing ANs at Baseline were counted. Any new ANs identified in an anatomical area that was initially free of ANs at Baseline were not counted. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-trea

Group	Value	95% CI
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID	-3.85	± 0.362
DBVC Period: Vehicle Cream BID	-3.17	± 0.323

Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16 Secondary · Baseline; Week 16

The Skin Pain NRS is a daily participant-reported measure (24-hour recall) of the worst level of skin pain related to Hidradenitis Suppurativa. The participants rated the pain severity of their Hidradenitis Suppurativa by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described their worst level of pain in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as

Group	Value	95% CI
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID	-1.90	± 0.532
DBVC Period: Vehicle Cream BID	-2.09	± 0.497

Change From Baseline in Itch NRS Score at Week 16 Secondary · Baseline; Week 16

The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity related to Hidradenitis Suppurativa. The participants rated the itch severity of their Hidradenitis Suppurativa by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated

Group	Value	95% CI
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID	-1.45	± 0.538
DBVC Period: Vehicle Cream BID	-2.39	± 0.493

Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 Secondary · Baseline; Week 16

HiSCR was defined as at least a 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to Baseline.

Group	Value	95% CI
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID	79.2
DBVC Period: Vehicle Cream BID	50.0

Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16 Secondary · Baseline; Week 16

The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. IHS4 score was 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). Scores: mild=0-3; moderate=4-10; severe ≥11. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 val

Group	Value	95% CI
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID	-3.58	± 0.505
DBVC Period: Vehicle Cream BID	-2.76	± 0.459

Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period Secondary · up to Week 16 plus 30 days

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.

Group	Value	95% CI
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID	13
DBVC Period: Vehicle Cream BID	15

Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period Secondary · up to Week 16 plus 30 days

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age

Group	Value	95% CI
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID	0
DBVC Period: Vehicle Cream BID	2

Number of Participants With Any TEAE in the Open-label Extension (OLE) Period Secondary · from Week 17 up to Week 32 plus 30 days

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.

Group	Value	95% CI
OLE Period: Ruxolitinib 1.5% Cream BID	8
OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	15

Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period Secondary · from Week 17 up to Week 32 plus 30 days

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3:

Group	Value	95% CI
OLE Period: Ruxolitinib 1.5% Cream BID	0
OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID	3

Adverse events — posted to ClinicalTrials.gov

Time frame: up to Week 32 plus 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vehicle Cream BID

Serious: 1/35 (3%)

Deaths: 0/35

Ruxolitinib 1.5% Cream BID

Serious: 2/66 (3%)

Deaths: 0/66

Serious adverse events (5 terms)

Reaction	System	Vehicle Cream BID	Ruxolitinib 1.5% Cream BID
Acute kidney injury	Renal and urinary disorders	—	—
Atelectasis	Respiratory, thoracic and mediastinal disorders	—	—
Crohn's disease	Gastrointestinal disorders	—	—
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Vehicle Cream BID	Ruxolitinib 1.5% Cream BID
Nasopharyngitis	Infections and infestations	—	—
Nausea	Gastrointestinal disorders	—	—

Most-reported serious reactions: Acute kidney injury, Atelectasis, Crohn's disease, Diabetic ketoacidosis, Systemic lupus erythematosus.

Data from ClinicalTrials.gov NCT05635838 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Current Clinical Trial Landscape for Hidradenitis Suppurativa: A Narrative Review.
   Hunt A, Qian V, Olds H, Daveluy S. · · 2023 · cited 10× · PMID 37261652 · DOI 10.1007/s13555-023-00935-x
2. Emerging Treatments and the Clinical Trial Landscape for Hidradenitis Suppurativa Part I: Topical and Systemic Medical Therapies.
   Fragoso NM, Masson R, Gillenwater TJ, Shi VY, et al · · 2023 · cited 9× · PMID 37402031 · DOI 10.1007/s13555-023-00956-6
3. Abstracts of the 9th Annual Symposium on Hidradenitis Suppurativa Advances 2024 : Austin, Texas | November 1-3, 2024.
   · 2025 · PMID 39951203 · DOI 10.1007/s13555-025-01343-z