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The trial enrolls patients with moderate to severe Hidradenitis Suppurativa (HS). The primary goal of the trial is to evaluate the safety and tolerability of IFX-1 administered over 8 weeks in these patients. In addition the trial aims to characterize the pharmacokinetics and pharmacodynamics of IFX-1 as well as to generate preliminary data on the efficacy of IFX-1 on clinical endpoints (e.g., Hidradenitis Suppurativa Clinical Response (HiSCR), Dermatology Life Quality Index (DLQI), Visual Analog Scale (VAS) for disease, VAS for pain, Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA), Modified Sartorius Score (mSS)).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFX-1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IFX-1 | Biological | chimeric, monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with at least possibly related treatment-emergent adverse events (TEAEs) | up to Day 134 | |
| Number of patients with detection of anti-drug antibodies (pre-/post-dosing) | up to Day 134 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of IFX-1 | From Day 1 until Day 134 | |
| Plasma concentration of C5a | Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134 | |
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Inclusion Criteria:
Exclusion Criteria:
Body weight above 150 kg or body weight below 60 kg
Has a draining fistula count of greater than 30 at baseline
Surgical management planned within the next 24 weeks
Occurrence of a flare-up of HS leading to intravenous antimicrobial treatment within the last 14 days
Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study
One of the following abnormal laboratory results
Prior administration of any biological compound in the last 3 months
Intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1 mg/kg for the last three weeks;
Intake of Immunosuppressive drugs within past 30 days (e.g., cyclosporine, tacrolimus)
General exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATTIKON University Hospital | Athens | 12462 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34252397 | Derived | Prens LM, Ardon CB, van Straalen KR, van der Zee HH, Seelen MAJ, Laman JD, Prens EP, Horvath B, Damman J. No Evident Systemic Terminal Complement Pathway Activation in Hidradenitis Suppurativa. J Invest Dermatol. 2021 Dec;141(12):2966-2969.e1. doi: 10.1016/j.jid.2021.03.037. Epub 2021 Jul 9. No abstract available. |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000706656 | vilobelimab |
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| Percentage change from baseline in total abscess and nodule (AN) count per time point |
| Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134 |
| Hidradenitis Suppurativa Clinical Response (HiSCR) per time point | Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134 |
| Achievement of Hidradenitis Suppurativa - Physician's Global Assessment (HS-PGA) of clear, minimal, or mild among patients with at least 2 grades improvement (reduction) from baseline | Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134 |
| HS-PGA score per time point | Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134 |
| Achievement of at least a 30% reduction and at least a 10 mm reduction in the Visual Analog Scale (VAS) for pain, among patients who had a baseline pain assessment ≥ 30 mm | At each visit from Day 1 until Day 134 |
| VAS pain score per time point | At each visit from Day 1 until Day 134 |
| Change from baseline in VAS pain score per time point | At each visit from Day 1 until Day 134 |
| VAS disease score per time | At each visit from Day 1 until Day 134 |
| Change from baseline in VAS disease score per time point | At each visit from Day 1 until Day 134 |
| Dermatology Life Quality Index (DLQI) per time point | Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134 |
| Change from baseline in DLQI per time point | Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134 |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |