Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS) (SHINE)

InflaRx

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa (HS)

Treatments: Drug: Placebo; Drug: IFX-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03487276

IFX-1-P2.4

Details and patient eligibility

About

The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.

Full description

Hidradenitis suppurativa (HS) is a chronic devastating skin disorder affecting areas rich in apocrine glands. HS is diagnosed by its clinical features and its chronicity. It is recognized by the presence of recurrent, painful, deep-seated, rounded nodules usually ending in abscesses and sinus tracts with suppuration and hypertrophic scarring. As complement C5a is involved in the underlying acute inflammatory responses, this study is set up based on the hypothesis that IFX-1 might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, ≥ 18 years of age
• Written informed consent obtained from subject
• Diagnosis of HS for at least 1 year
• Moderate or severe HS, as indicated by HS lesions in at least 2 distinct areas, 1 of which must be at least Hurley Stage II or Stage III
• Inadequate response to at least 3 months of oral antibiotics, or intolerance to antibiotics
• Total abscess and inflammatory nodule (AN) count of ≥ 3

Exclusion criteria

• Prior treatment with adalimumab or another biologic product during the 24 weeks before Screening

• Subjects on permitted oral antibiotic treatment for HS (doxycycline or minocycline only) who have not been on a stable dose during the 28 days before Screening

• Subject received systemic non-biologic therapy for HS with potential therapeutic impact for HS during the 28 days before Screening (other than permitted oral antibiotics)

• Prior treatment with any of the following medications during the 28 days before Screening:

  • Any other systemic therapy for HS
  • Any iv anti-infective therapy
  • Phototherapy (ultraviolet B or psoralen and ultraviolet A)

• History of heart disease or malignancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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179 participants in 5 patient groups, including a placebo group

Cohort 1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Cohort 2

Experimental group

Description:

Minimum Dose IFX-1 (400 mg Q4W)

Treatment:

Drug: IFX-1

Cohort 3

Experimental group

Description:

Low dose IFX-1 (800 mg Q4W)

Treatment:

Drug: IFX-1

Cohort 4

Experimental group

Description:

Medium Dose IFX-1 (800 mg Q2W)

Treatment:

Drug: IFX-1

Cohort 5

Experimental group

Description:

High Dose IFX-1 (1200 mg Q2W)

Treatment:

Drug: IFX-1