A 24-Week Real-World Study of Upadacitinib in Moderate-to-Severe Hidradenitis Suppurativa

NCT07727889 | Active Not Recruiting Phase 2

• 1 other identifier: No. I-25PJ3021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hidradenitis Suppurativa (Acne Inversa)

Keywords

Upadacitinib; Janus kinase inhibitor; JAK1 inhibitor; Hidradenitis suppurativa; Acne inversa; Real-world study; HiSCR; IHS4; Refractory hidradenitis suppurativa; Moderate-to-severe hidradenitis suppurativa

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 24

Study Arms (1)

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.

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

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.

Upadacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Peking Union Medical College: lead

Study Sites (1)

No. 1 Shuai Fu Yuan, Dongcheng District, Beijing

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Dermatology Department

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)