Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa

NCT03001622 | Completed Phase 2

• 1 other identifier: IFX-1-P2.3
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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)).

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (13)

• 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

• 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

Study Arms (1)

IFX-1

OTHER

Biological: IFX-1

Interventions

IFX-1 BIOLOGICAL

chimeric, monoclonal antibody

IFX-1

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 patients ≥ 18 years old
• Written informed consent
• Diagnosis of HS for at least 1 year
• Hidradenitis suppurativa (HS) lesions in at least 2 distinct anatomic areas, one of which is Hurley Stage II or III
• Total AN (abscesses and nodules) count ≥3
• Patients with either primary or secondary failure of biological treatment or are not eligible for treatment with other biologicals
• Failure of previous antimicrobial treatments

You may not qualify if:

• 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
• Active infection
• Severe congestive heart failure (i.e., New York Heart Association (NYHA) Class IV)
• Depression
• History of systemic lupus erythematosus or rheumatoid arthritis
• Any immunodeficiency disease
• Active hematological or solid malignant tumor
• Patients must not have had any other active skin disease or condition (e.g., bacterial, fungal, or viral infection) that may have interfered with assessment of HS.
• One of the following abnormal laboratory results
• White blood cell count \< 2,500/mm3
• Neutrophil count \< 1000/mm3

Sponsors & Collaborators

• InflaRx GmbH: lead

Study Sites (1)

ATTIKON University Hospital

Athens, 12462, Greece

Location

Related Publications (1)

• 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.

  PMID: 34252397 DERIVED

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

vilobelimab

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 23, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)