Trial · NCT05635838
Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
NCT05635838, Phase 2, Completed, Incyte Corporation; results first posted 2024-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa. Trials, record NCT05635838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05635838
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
- NCT number
- NCT05635838
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 69 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Ruxolitinib cream, Vehicle cream
- First posted
- 2022-12-02
- Last updated
- 2024-11-01
- Results first posted
- 2024-11-01
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | 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. |
| Secondary | Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | 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. |
| Secondary | Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline | 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-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value. |
| Secondary | Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16 | 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 the Week 16 value minus the Baseline value. |
| Secondary | Change From Baseline in Itch NRS Score at Week 16 | 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 as the Week 16 value minus the Baseline value. |
| Secondary | Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | 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. |
| Secondary | Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16 | 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 value minus the Baseline value. |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period | 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. |
| Secondary | Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period | 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-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. |
| Secondary | Number of Participants With Any TEAE in the Open-label Extension (OLE) Period | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | Baseline; Week 16 | Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were defined according to treatment assignment at randomization. Only participants with available data were analyzed. | ANs | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | Baseline; Week 16 | ITT Population. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline | Baseline; Week 16 | ITT Population. Only participants with available data were analyzed. | ANs | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16 | Baseline; Week 16 | ITT Population. Only participants with available data were analyzed. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Itch NRS Score at Week 16 | Baseline; Week 16 | ITT Population. Only participants with available data were analyzed. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 | Baseline; Week 16 | ITT Population. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16 | Baseline; Week 16 | ITT Population. Only participants with available data were analyzed. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period | up to Week 16 plus 30 days | Safety Population: all participants who applied ruxolitinib 1.5% cream or vehicle cream at least once. Treatment groups were determined according to the actual treatment the participant applied on Day 1 regardless of assigned treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period | up to Week 16 plus 30 days | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any TEAE in the Open-label Extension (OLE) Period | from Week 17 up to Week 32 plus 30 days | Open-label Extension Safety Population: all participants who applied ruxolitinib 1.5% cream BID at least once during the OLE Period | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | -3.61 | Standard Error 0.378 | ANs | |
| Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16 | DBVC Period: Vehicle Cream BID | -2.42 | Standard Error 0.336 | ANs | |
| Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | AN50 | 79.2 | percentage of participants | |
| Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | DBVC Period: Vehicle Cream BID | AN50 | 56.3 | percentage of participants | |
| Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | AN75 | 54.2 | percentage of participants | |
| Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | DBVC Period: Vehicle Cream BID | AN75 | 25.0 | percentage of participants | |
| Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | AN90 | 20.8 | percentage of participants | |
| Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | DBVC Period: Vehicle Cream BID | AN90 | 12.5 | percentage of participants | |
| Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | AN100 | 20.8 | percentage of participants | |
| Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16 | DBVC Period: Vehicle Cream BID | AN100 | 12.5 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 16-Week DBVC Period | STARTED | Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | 34 | |
| 16-Week DBVC Period | STARTED | DBVC Period: Vehicle Cream BID | 35 | |
| 16-Week DBVC Period | STARTED | Open-label Extension (OLE) Period: Ruxolitinib 1.5% Cream BID | 0 | |
| 16-Week DBVC Period | STARTED | OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | 0 | |
| 16-Week DBVC Period | COMPLETED | Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | 24 | |
| 16-Week DBVC Period | COMPLETED | DBVC Period: Vehicle Cream BID | 32 | |
| 16-Week DBVC Period | COMPLETED | Open-label Extension (OLE) Period: Ruxolitinib 1.5% Cream BID | 0 | |
| 16-Week DBVC Period | COMPLETED | OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID | 0 | |
| 16-Week DBVC Period | NOT COMPLETED | Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID | 10 | |
| 16-Week DBVC Period | NOT COMPLETED | DBVC Period: Vehicle Cream BID | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Vehicle Cream BID | 0 | 35 | 0 |
| other | Nasopharyngitis | Infections and infestations | Ruxolitinib 1.5% Cream BID | 5 | 66 | 5 |
| other | Nausea | Gastrointestinal disorders | Vehicle Cream BID | 2 | 35 | 2 |
| other | Nausea | Gastrointestinal disorders | Ruxolitinib 1.5% Cream BID | 0 | 66 | 0 |
| serious | Acute kidney injury | Renal and urinary disorders | Vehicle Cream BID | 0 | 35 | 0 |
| serious | Acute kidney injury | Renal and urinary disorders | Ruxolitinib 1.5% Cream BID | 1 | 66 | 1 |
| serious | Atelectasis | Respiratory, thoracic and mediastinal disorders | Vehicle Cream BID | 0 | 35 | 0 |
| serious | Atelectasis | Respiratory, thoracic and mediastinal disorders | Ruxolitinib 1.5% Cream BID | 1 | 66 | 1 |
| serious | Crohn's disease | Gastrointestinal disorders | Vehicle Cream BID | 0 | 35 | 0 |
| serious | Crohn's disease | Gastrointestinal disorders | Ruxolitinib 1.5% Cream BID | 1 | 66 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle Cream BID | 0 | 35 |
| Total, all-cause mortality | Ruxolitinib 1.5% Cream BID | 0 | 66 |
| Total, other adverse events | Vehicle Cream BID | 2 | 35 |
| Total, other adverse events | Ruxolitinib 1.5% Cream BID | 5 | 66 |
| Total, serious adverse events | Vehicle Cream BID | 1 | 35 |
| Total, serious adverse events | Ruxolitinib 1.5% Cream BID | 2 | 66 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| OLE Period: Ruxolitinib 1.5% Cream BID vs OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID: Number of Participants With Any TEAE in the Open-label Extension (OLE) Period | Trial comparisons |
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID vs DBVC Period: Vehicle Cream BID: Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period | Trial comparisons |
| OLE Period: Ruxolitinib 1.5% Cream BID vs OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID: Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period | Trial comparisons |
| Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID vs DBVC Period: Vehicle Cream BID: Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period | Trial comparisons |
| Ruxolitinib 1.5% Cream BID vs Vehicle Cream BID: deaths from any cause | Trial comparisons |
| Ruxolitinib 1.5% Cream BID vs Vehicle Cream BID: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05635838
GET https://conductscience.org/api/trials/v1/NCT05635838/results?page=2