Comparative Evaluation of Changes in Clinical Severity and Inflammatory Biomarkers in Hidradenitis Suppurativa Patients Receiving Infliximab With Versus Without Adjunctive Tirzepatide (Spartina) Therapy
To compare the efficacy of adding Tirzepatide to Infliximab versus Infliximab alone on clinical severity, particularly Hidradenitis Suppurativa Clinical Response (HiSCR), and inflammatory biomarkers in patients with moderate-to-severe Hidradenitis Suppurativa over 24 weeks
Design
Phase 2, open-label, parallel-group, randomized controlled clinical trial on 20 patients. Simple randomization (1:1 ratio) will be used
Settings and conduct
The study will be conducted at Razi Hospital, affiliated with Tehran University of Medical Sciences. It is an open-label trial without blinding. Patients will be evaluated clinically at weeks 0, 8, 16, and 24
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 65 years; Hidradenitis Suppurativa at Hurley Stage II or III; Body Mass Index (BMI) >= 27; receiving stable Infliximab therapy for at least 12 weeks; written informed consent. Exclusion criteria: Personal or family history of Medullary Thyroid Carcinoma (MTC); Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); history of pancreatitis; diabetic retinopathy; pregnancy or breastfeeding; active malignancy; severe renal failure
Intervention groups
Intervention group: Subcutaneous injection of Tirzepatide (dose escalating from 2.5 to 7.5 mg/week) plus standard Infliximab therapy. Control group: Standard Infliximab therapy alone without placebo
Main outcome variables
Achievement of Hidradenitis Suppurativa Clinical Response (HiSCR) at week 24, assessed by clinical examination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230502058057N2
Registration date:2026-09-24, 1405/07/02
Registration timing:prospective
Last update:2026-09-24, 1405/07/02
Update count:0
Registration date
2026-09-24, 1405/07/02
Registrant information
Name
Bahram Davoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3344 0409
Email address
bahram.davoudi75@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-02, 1405/07/10
Expected recruitment end date
2027-04-30, 1406/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of Changes in Clinical Severity and Inflammatory Biomarkers in Hidradenitis Suppurativa Patients Receiving Infliximab With Versus Without Adjunctive Tirzepatide (Spartina) Therapy
Public title
The effect of adding Tirzepatide on severity of Hidradenitis Suppurativa in patients treated with Infliximab
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 65 years diagnosed with Hidradenitis Suppurativa (Hurley stage II or III)
BMI >= 27 kg/m2
Receiving stable and continuous treatment with Infliximab for at least 12 weeks
Written informed consent
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be randomly allocated into two equal groups (1:1 ratio) using simple randomization. The intervention group will receive Infliximab plus Tirzepatide, while the control group will continue Infliximab alone. This randomization aims to reduce bias and balance baseline characteristics.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of School of Medicine, Tehran University of Medical Sciences
At baseline (week 0), and weeks 8, 16, and 24 after the start of intervention
Method of measurement
Clinical examination by a dermatologist counting the number of inflammatory lesions (abscesses and nodules) and draining fistulas
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients receive subcutaneous injections of Tirzepatide (starting at 2.5 mg weekly and increasing to 7.5 mg over 8 weeks) in addition to their standard treatment with Infliximab
Category
Treatment - Drugs
2
Description
Control group: patients will continue their standard treatment with Infliximab only and will not receive any placebo or additional medication