Phase 2
N=179
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Hidradenitis Suppurativa (HS)
Bottom Line
View on ClinicalTrials.gov: NCT03487276 ↗Enrolled (actual)
179
Serious AEs
3.3%
Results posted
Apr 2021
Primary outcome: Primary: Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 — 16; 12; 17; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IFX-1 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- InflaRx GmbH
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 |
16; 12; 17; 12; 15; 18 | — |
| SECONDARY Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12 |
14; 14; 12; 13; 13; 20 | — |
| SECONDARY Number of Patients With Flares Relative to Day 1 |
6; 3; 1; 0; 1; 3 | — |
| SECONDARY Absolute Change in Modified Sartorius Score (mSS) From Day 1. |
-16.4; -17.5; -29.4; -22.9; -35.2; -47.9 | — |
| SECONDARY Absolute Change in Patient's Global Assessment of Skin Pain From Day 1. |
-1.2; -0.1; -0.7; -1.5; -1.8; -1.5 | — |
| SECONDARY Percentage of Patients Achieving NRS30 |
7; 6; 5; 9; 8; 12 | — |
| SECONDARY Percentage of Patients Achieving NRS50. |
6; 3; 2; 7; 5; 7 | — |
| SECONDARY Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1. |
-1.5; 0.6; -2.6; -5.0; -2.4; -1.5 | — |
| SECONDARY Safety Parameters (Adverse Events) Will be Assessed. |
26; 26; 21; 24; 22; 39 | — |
Summary
The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03487276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.