A Phase 2 interventional study of Upadacitinib in Hidradenitis Suppurativa (Acne Inversa), sponsored by Peking Union Medical College. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Peking Union Medical College · Phase 2, Interventional, and Treatment
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.
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.
277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.
This study's enrollment of 50 is above the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.
Browse Hidradenitis Suppurativa studies →Peking Union Medical College is the lead sponsor of 58 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Upadacitinib
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.
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.
Time frame: Baseline to Week 24
Plan to share: 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.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking Union Medical College