NCT06959225 · Incyte Corporation
Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)
What this study is about
The purpose of this study is to evaluate the effectiveness and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
View original scientific description
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
Interventions
DRUG
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
DRUG
Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Primary outcome measures
Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline
Time frame: Week 16
HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and/or inflammatory nodule (AN) count with no increase from baseline in abscess or draining tunnel count.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of HS for at least 6 months prior to screening visit.
- Mild to moderate HS (Hurley I or II) with the following at both screening and baseline visits:
- A total AN count of at least 4, with no draining tunnels AND
- Affecting at least 2 distinct anatomical areas
- Agreement to NOT use topical and systemic antibiotics for treatment of HS during the vehicle-controlled period.
- Agreement to NOT use topical antiseptics, including washes and leave-on products on the areas affected by HS lesions during the vehicle-controlled period and Weeks 16 to 20 of the extension period.
- Further inclusion criteria apply.
Exclusion criteria
- Body surface areas to be treated exceed 20% BSA at screening or baseline
- Presence of draining tunnels at screening or baseline.
- Medical history including current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
- Laboratory values
Where
- Phoenix, Arizona
- Scottsdale, Arizona
- Tempe, Arizona
- Fayetteville, Arkansas
- Brea, California
- Laguna Niguel, California
- Los Angeles, California
- San Diego, California
- Aurora, Colorado
- Boynton Beach, Florida
- Fort Myers, Florida
- Miami, Florida
And 42 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations