Hidradenitis Suppurativa (Acne Inversa)Phase 2NCT07727889
A 24-Week Real-World Study of Upadacitinib in Moderate-to-Severe Hidradenitis Suppurativa
A Phase 2 study testing Upadacitinib in people with Hidradenitis Suppurativa (Acne Inversa), run by Peking Union Medical College at 1 site in China.
Trial summary
Hidradenitis suppurativa is a chronic, recurrent inflammatory skin disease characterized by painful inflammatory nodules, abscesses, draining tunnels, and scarring. Patients with moderate-to-severe disease may experience inadequate responses, intolerance, or loss of response to conventional systemic therapies and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa (Acne Inversa)
- What is being tested?
- Upadacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 years or older.
- Diagnosis of moderate-to-severe hidradenitis suppurativa confirmed by a dermatologist, generally corresponding to Hurley stage II or III, or active hidradenitis suppurativa considered by the investigator to require systemic treatment.
- Presence of evaluable inflammatory lesions at baseline, allowing assessment of abscess and inflammatory nodule count, IHS4, pain NRS, pruritus NRS, and DLQI.
- Considered by the investigator to be an appropriate candidate for treatment with upadacitinib in a real-world clinical setting.
- Willing and able to comply with scheduled visits, laboratory testing, contraceptive requirements, and safety follow-up.
- Able to understand the real-world and exploratory nature of the study and that upadacitinib is an investigational and off-label treatment for hidradenitis suppurativa.
- Willing to provide written informed consent.
Who cannot join
- A condition requiring urgent treatment, inpatient antimicrobial treatment, extensive surgery, or another emergency intervention that, in the investigator's judgment, makes participation inappropriate.
- Active serious infection, active tuberculosis, uncontrolled chronic or recurrent infection, or another condition associated with an unacceptable risk of immunosuppression.
- Screening results indicating hepatitis B, hepatitis C, human immunodeficiency virus infection, tuberculosis, or another infection risk that requires postponement of immunomodulatory treatment and makes participation inappropriate.
- Clinically significant cytopenia, severe hepatic or renal impairment, or another laboratory abnormality that makes treatment with upadacitinib inappropriate.
- Previous venous thromboembolism, a serious major adverse cardiovascular event, active malignancy, or another condition for which the investigator considers the risk of a Janus kinase inhibitor unacceptable.
- Pregnancy, breastfeeding, or plans to become pregnant during the study.
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- A participant of childbearing potential who is unable or unwilling to use effective contraception during the study.
- Known serious hypersensitivity or contraindication to upadacitinib or any component of the formulation.
- Recent participation in another interventional clinical study or another condition that may interfere with the evaluation of effectiveness or safety.
- Any unacceptable safety risk or inability to obtain key effectiveness or safety data, as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
No. 1 Shuai Fu Yuan, Dongcheng District, Beijing
Beijing, Beijing Municipality, 100730
About this study
Official title: A Single-Center, Prospective, Open-Label, Exploratory, Single-Arm Real-World Study of Upadacitinib in Patients With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis suppurativa is a chronic, recurrent inflammatory skin disease characterized by painful inflammatory nodules, abscesses, draining tunnels, and scarring. Patients with moderate-to-severe disease may experience inadequate responses, intolerance, or loss of response to conventional systemic therapies and biologic agents.
This prospective, open-label, single-arm, real-world study will evaluate the effectiveness, safety, patient-reported outcomes, and treatment persistence of upadacitinib in 50 adults with moderate-to-severe hidradenitis suppurativa over 24 weeks. Participants will receive oral upadacitinib in routine clinical practice. A starting dose of 15 mg once daily is recommended. The dose may be increased to 30 mg once daily based on disease severity, treatment response, safety findings, drug accessibility, and shared decision-making between the investigator and the participant.
Effectiveness assessments will include the Hidradenitis Suppurativa Clinical Response, abscess and inflammatory nodule count, International Hidradenitis Suppurativa Severity Score System, pain and pruritus numerical rating scales, Dermatology Life Quality Index, disease flares, rescue treatments, and surgical interventions. Safety assessments will include adverse events, serious adverse events, laboratory abnormalities, infections, thromboembolic events, major adverse cardiovascular events, hepatic abnormalities, lipid abnormalities, and cytopenias.
Read the detailed description
Hidradenitis suppurativa is a chronic, recurrent, inflammatory, and scarring skin disease that substantially affects pain, sleep, psychological well-being, social functioning, and quality of life. Although systemic antibiotics, retinoids, immunomodulatory agents, biologic therapies, and surgery are available, patients with moderate-to-severe or refractory disease frequently experience inadequate disease control, recurrent flares, persistent draining tunnels, treatment interruption, or failure of multiple treatment lines.
The Janus kinase-signal transducer and activator of transcription pathway is involved in the signaling of multiple inflammatory cytokines implicated in hidradenitis suppurativa. Upadacitinib is a selective Janus kinase 1 inhibitor. Preliminary randomized clinical trial and real-world evidence suggests that upadacitinib may improve inflammatory lesion counts, hidradenitis suppurativa clinical response, disease severity, pain, and quality of life. However, upadacitinib remains an investigational and off-label treatment for hidradenitis suppurativa, and additional real-world data are required to characterize its effectiveness, optimal dosing, treatment persistence, and safety.
This is a single-center, prospective, open-label, exploratory, single-arm investigator-initiated study conducted in a routine clinical care setting. Approximately 50 adults with moderate-to-severe hidradenitis suppurativa will be enrolled and followed for 24 weeks.
A starting regimen of upadacitinib 15 mg orally once daily is recommended. For participants with severe disease, a high baseline inflammatory burden, or an inadequate clinical response, the dose may be increased to 30 mg once daily when considered clinically appropriate and acceptable from a safety perspective. Dose selection and adjustment will be based on the investigator's clinical judgment, participant preference, drug accessibility, prior treatment, comorbidities, and safety assessment. All dose changes, interruptions, discontinuations, concomitant treatments, rescue treatments, and surgical procedures will be documented.
Study assessments are planned at screening, baseline, Week 4, Week 12, and Week 24. Safety follow-up will be conducted after the last dose of upadacitinib. Laboratory monitoring will include complete blood count, hepatic and renal function, serum lipids, creatine kinase, and other clinically indicated assessments. Participants will be screened for tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus infection, pregnancy, and relevant cardiovascular or thromboembolic risks before treatment.
The primary objective is to estimate the proportion of participants achieving a Hidradenitis Suppurativa Clinical Response of at least 50% at Week 24. Secondary and exploratory analyses will evaluate higher response thresholds, changes in disease activity, patient-reported outcomes, treatment persistence, dose modification, safety outcomes, and potential baseline predictors of treatment response.
- Conditions
- Hidradenitis Suppurativa (Acne Inversa)
- Being tested
- Upadacitinib
- Keywords
- Upadacitinib, Janus kinase inhibitor, JAK1 inhibitor, Hidradenitis suppurativa, Acne inversa, Real-world study, HiSCR, IHS4, Refractory hidradenitis suppurativa, Moderate-to-severe hidradenitis suppurativa
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Upadacitinib will be administered orally once daily for up to 24 weeks. The recommended starting dose is 15 mg once daily. Dose escalation to 30 mg once daily may be implemented according to clinical response, disease severity, safety findings, participant preference, and drug accessibility. Participants will obtain the medication through a physician's prescription and will bear the medication costs according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib | Experimental | Participants will receive oral upadacitinib for 24 weeks in a routine clinical care setting. The recommended starting dose is 15 mg once daily. The dose may be increased to 30 mg once daily for participants with severe disease, a high inflammatory burden, or an inadequate clinical response, provided that the investigator determines that the potential benefit outweighs the safety risk. Dose adjustments, treatment interruptions, discontinuations, concomitant therapies, and rescue interventions will be documented. Receives: Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving HiSCR50 at Week 24
HiSCR50 is defined as at least a 50% reduction from baseline in the combined abscess and inflammatory nodule count, with no increase from baseline in the number of abscesses and no increase from baseline in the number of draining tunnels.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Jul 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (Acne Inversa)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Ma, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727889
- Sponsor's protocol ID
- No. I-25PJ3021
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because this is a small, single-center study involving detailed clinical and safety information from patients with a relatively uncommon disease, individual participant data will not be made publicly available. Deidentified aggregate data may be reported in scientific publications. Requests for additional deidentified data may be considered by the principal investigator in accordance with participant consent, institutional policy, ethics approval, and applicable data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Open-Label, Exploratory, Single-Arm Real-World Study of Upadacitinib in Patients With Moderate-to-Severe Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT07727889
- Acronym / sponsor ID
- No. I-25PJ3021
- Conditions
- Hidradenitis Suppurativa (Acne Inversa)
- Keywords
- Upadacitinib, Janus kinase inhibitor, JAK1 inhibitor, Hidradenitis suppurativa, Acne inversa, Real-world study, HiSCR, IHS4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hidradenitis suppurativa is a chronic, recurrent inflammatory skin disease characterized by painful inflammatory nodules, abscesses, draining tunnels, and scarring. Patients with moderate-to-severe disease may experience inadequate responses, intolerance, or loss of response to conventional systemic therapies and biologic agents.
This prospective, open-label, single-arm, real-world study will evaluate the effectiveness, safety, patient-reported outcomes, and treatment persistence of upadacitinib in 50 adults with moderate-to-severe hidradenitis suppurativa over 24 weeks. Participants will receive oral upadacitinib in routine clinical practice. A starting dose of 15 mg once daily is recommended. The dose may be increased to 30 mg once daily based on disease severity, treatment response, safety findings, drug accessibility, and shared decision-making between the investigator and the participant.
Effectiveness assessments will include the Hidradenitis Suppurativa Clinical Response, abscess and inflammatory nodule count, International Hidradenitis Suppurativa Severity Score System, pain and pruritus numerical rating scales, Dermatology Life Quality Index, disease flares, rescue treatments, and surgical interventions. Safety assessments will include adverse events, serious adverse events, laboratory abnormalities, infections, thromboembolic events, major adverse cardiovascular events, hepatic abnormalities, lipid abnormalities, and cytopenias.
Detailed description
Hidradenitis suppurativa is a chronic, recurrent, inflammatory, and scarring skin disease that substantially affects pain, sleep, psychological well-being, social functioning, and quality of life. Although systemic antibiotics, retinoids, immunomodulatory agents, biologic therapies, and surgery are available, patients with moderate-to-severe or refractory disease frequently experience inadequate disease control, recurrent flares, persistent draining tunnels, treatment interruption, or failure of multiple treatment lines.
The Janus kinase-signal transducer and activator of transcription pathway is involved in the signaling of multiple inflammatory cytokines implicated in hidradenitis suppurativa. Upadacitinib is a selective Janus kinase 1 inhibitor. Preliminary randomized clinical trial and real-world evidence suggests that upadacitinib may improve inflammatory lesion counts, hidradenitis suppurativa clinical response, disease severity, pain, and quality of life. However, upadacitinib remains an investigational and off-label treatment for hidradenitis suppurativa, and additional real-world data are required to characterize its effectiveness, optimal dosing, treatment persistence, and safety.
This is a single-center, prospective, open-label, exploratory, single-arm investigator-initiated study conducted in a routine clinical care setting. Approximately 50 adults with moderate-to-severe hidradenitis suppurativa will be enrolled and followed for 24 weeks.
A starting regimen of upadacitinib 15 mg orally once daily is recommended. For participants with severe disease, a high baseline inflammatory burden, or an inadequate clinical response, the dose may be increased to 30 mg once daily when considered clinically appropriate and acceptable from a safety perspective. Dose selection and adjustment will be based on the investigator's clinical judgment, participant preference, drug accessibility, prior treatment, comorbidities, and safety assessment. All dose changes, interruptions, discontinuations, concomitant treatments, rescue treatments, and surgical procedures will be documented.
Study assessments are planned at screening, baseline, Week 4, Week 12, and Week 24. Safety follow-up will be conducted after the last dose of upadacitinib. Laboratory monitoring will include complete blood count, hepatic and renal function, serum lipids, creatine kinase, and other clinically indicated assessments. Participants will be screened for tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus infection, pregnancy, and relevant cardiovascular or thromboembolic risks before treatment.
The primary objective is to estimate the proportion of participants achieving a Hidradenitis Suppurativa Clinical Response of at least 50% at Week 24. Secondary and exploratory analyses will evaluate higher response thresholds, changes in disease activity, patient-reported outcomes, treatment persistence, dose modification, safety outcomes, and potential baseline predictors of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib | Experimental | Drug: UpadacitinibParticipants will receive oral upadacitinib for 24 weeks in a routine clinical care setting. The recommended starting dose is 15 mg once daily. The dose may be increased to 30 mg once daily for participants with severe disease, a high inflammatory burden, or an inadequate clinical response, provided that the investigator determines that the potential benefit outweighs the safety risk. Dose adjustments, treatment interruptions, discontinuations, concomitant therapies, and rescue interventions will be documented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female participants aged 18 years or older.
- Diagnosis of moderate-to-severe hidradenitis suppurativa confirmed by a dermatologist, generally corresponding to Hurley stage II or III, or active hidradenitis suppurativa considered by the investigator to require systemic treatment.
- Presence of evaluable inflammatory lesions at baseline, allowing assessment of abscess and inflammatory nodule count, IHS4, pain NRS, pruritus NRS, and DLQI.
- Considered by the investigator to be an appropriate candidate for treatment with upadacitinib in a real-world clinical setting.
- Willing and able to comply with scheduled visits, laboratory testing, contraceptive requirements, and safety follow-up.
Key exclusion criteria (10 listed)
- A condition requiring urgent treatment, inpatient antimicrobial treatment, extensive surgery, or another emergency intervention that, in the investigator's judgment, makes participation inappropriate.
- Active serious infection, active tuberculosis, uncontrolled chronic or recurrent infection, or another condition associated with an unacceptable risk of immunosuppression.
- Screening results indicating hepatitis B, hepatitis C, human immunodeficiency virus infection, tuberculosis, or another infection risk that requires postponement of immunomodulatory treatment and makes participation inappropriate.
- Clinically significant cytopenia, severe hepatic or renal impairment, or another laboratory abnormality that makes treatment with upadacitinib inappropriate.
- Previous venous thromboembolism, a serious major adverse cardiovascular event, active malignancy, or another condition for which the investigator considers the risk of a Janus kinase inhibitor unacceptable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpadacitinibUpadacitinib will be administered orally once daily for up to 24 weeks. The recommended starting dose is 15 mg once daily. Dose escalation to 30 mg once daily may be implemented according to clinical response, disease severity, safety findings, participant preference, and drug accessibility. Participants will obtain the medication through a physician's prescription and will bear the medication costs according to routine clinical practice. | Drug | Upadacitinib |
Primary outcome
Proportion of Participants Achieving HiSCR50 at Week 24
Time frame: Baseline to Week 24
HiSCR50 is defined as at least a 50% reduction from baseline in the combined abscess and inflammatory nodule count, with no increase from baseline in the number of abscesses and no increase from baseline in the number of draining tunnels.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. Because this is a small, single-center study involving detailed clinical and safety information from patients with a relatively uncommon disease, individual participant data will not be made publicly available. Deidentified aggregate data may be reported in scientific publications. Requests for additional deidentified data may be considered by the principal investigator in accordance with participant consent, institutional policy, ethics approval, and applicable data protection requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Upadacitinib in people with Hidradenitis Suppurativa (Acne Inversa), run by Peking Union Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving HiSCR50 at Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.