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

NCT03487276 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IFX-1-P2.4
• Study Type: interventional
• Target: 179
• Locations: 9 countries
• Sites: 41

Brief 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.

Conditions

Hidradenitis Suppurativa (HS)

Keywords

hidradenitis suppurativa; monoclonal antibody; complement factor C5a; IFX-1; hidradenitis Suppurativa Clinical Response; Inflammation; skin diseases

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16

  The primary efficacy endpoint of the percentage of patients with HiSCR at Week 16 was analyzed using the multiple comparisons procedure-modelling (MCP-Mod) procedure. The definition for response to treatment based on HiSCR relative to Baseline was: at least 50% reduction in abscesses and inflammatory nodule (AN) count (over all anatomical regions) with no increase in number of abscesses and in number of draining fistulas.

  Week 16

Secondary Outcomes (8)

• Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12

  Week 12

• Number of Patients With Flares Relative to Day 1

  From Day 1 until Day 309

• Absolute Change in Modified Sartorius Score (mSS) From Day 1.

  From Day 1 until Day 309

• Absolute Change in Patient's Global Assessment of Skin Pain From Day 1.

  From Day 1 until Day 309

• Percentage of Patients Achieving NRS30

  From Day 1 until Day 309

Study Arms (5)

Cohort 1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Cohort 2

EXPERIMENTAL

Minimum Dose IFX-1 (400 mg Q4W)

Drug: IFX-1

Cohort 3

EXPERIMENTAL

Low dose IFX-1 (800 mg Q4W)

Drug: IFX-1

Cohort 4

EXPERIMENTAL

Medium Dose IFX-1 (800 mg Q2W)

Drug: IFX-1

Cohort 5

EXPERIMENTAL

High Dose IFX-1 (1200 mg Q2W)

Drug: IFX-1

Interventions

IFX-1 DRUG

Single IV infusions of IFX-1 diluted in sodium chloride.

Also known as: CaCP29, Vilobelimab

Cohort 2; Cohort 3; Cohort 4; Cohort 5

Placebo DRUG

Placebo

Cohort 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, ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InflaRx GmbH: lead
• Quintiles, Inc.: collaborator

Study Sites (41)

InflaRX Investigational Site

Birmingham, Alabama, 35233, United States

Location

InflaRX Investigational Site

Fort Myers, Florida, 33912, United States

Location

InflaRX Investigational Site

Miami, Florida, 33136, United States

Location

InflaRX Investigational Site

Sandy Springs, Georgia, 30328, United States

Location

InflaRX Investigational Site

Dearborn, Michigan, 48124, United States

Location

InflaRX Investigational Site

Columbia, Missouri, 65212, United States

Location

InflaRx Investigational Site

Saint Joseph, Missouri, 64506, United States

Location

InflaRX Investigational Site

St Louis, Missouri, 63104, United States

Location

InflaRX Investigational Site

St Louis, Missouri, 63110, United States

Location

InflaRX Investigational Site

Chapel Hill, North Carolina, 27516, United States

Location

InflaRX Investigational Site

Cincinnati, Ohio, 45219, United States

Location

InflaRX Investigational Site

Hershey, Pennsylvania, 17033, United States

Location

InflaRx Investigational Site

Goodlettsville, Tennessee, 37072, United States

Location

InflaRX Investigational Site

Sofia, 1431, Bulgaria

Location

InflaRX Investigational Site

Sofia, 1606, Bulgaria

Location

InflaRX Investigational Site

Stara Zagora, 6003, Bulgaria

Location

InflaRX Investigational Site

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

InflaRX Investigational Site

Peterborough, Ontario, K9J 5K2, Canada

Location

InflaRX Investigational Site

Richmond Hill, Ontario, L4C 9M7, Canada

Location

InflaRX Investigational Site

Copenhagen, 2400, Denmark

Location

InflaRX Investigational Site

Roskilde, 4000, Denmark

Location

InflaRX Investigational Site

Nice, Alpes Maritimes, 06202, France

Location

InflaRX Investigational Site

Bordeaux, Gironde, 33000, France

Location

InflaRX Investigational Site

Toulouse, Haute Garonne, 31059, France

Location

InflaRX Investigational Site

Antony, Hauts De Seine, 92160, France

Location

InflaRX Investigational Site

Nantes, Loire Atlantique, 44093, France

Location

InflaRX Investigational Site

Paris, 75475, France

Location

InflaRX Investigational Site

Darmstadt, Hesse, 64297, Germany

Location

InflaRX Investigational Site

Frankfurt am Main, Hesse, 60590, Germany

Location

InflaRX Investigational Site

Bochum, North Rhine-Westphalia, 44791, Germany

Location

InflaRX Investigational Site

Dessau, Saxony-Anhalt, 06847, Germany

Location

InflaRX Investigational Site

Athens, 115 25, Greece

Location

InflaRX Investigational Site

Athens, 12462, Greece

Location

InflaRX Investigational Site

Thessaloniki, 54645, Greece

Location

InflaRX Investigational Site

Rotterdam, 3015 CE, Netherlands

Location

InflaRX Investigational Site

Gdansk, 80-402, Poland

Location

InflaRX Investigational Site

Krakow, 30-033, Poland

Location

InflaRX Investigational Site

Kłodzko, 57-300, Poland

Location

InflaRX Investigational Site

Lodz, 90-436, Poland

Location

InflaRX Investigational Site

Wroclaw, 50-566, Poland

Location

InflaRX Investigational Site

Wroclaw, 51-318, Poland

Location

Related Publications (2)

• Giamarellos-Bourboulis EJ, Jemec GBE, Prens EP, Riedemann NC, Otto I, Weisman J, Pulka G, Nowicki RJ, Kantardjiev V, Pinter A, Thomsen SF, Berneman D, Kanni T, Alavi A, Breno B, Gooderham M, Stone M, Anadkat MJ, Katoulis A, Papakonstantis M, Becherel PA, Szepietowski JC, van der Zee HH, Zouboulis CC, Sayed CJ. Vilobelimab to improve clinical outcomes in moderate-to-severe hidradenitis suppurativa through an adjunctive effect on draining tunnels: results of the SHINE double-blind placebo-controlled randomized trial. Br J Dermatol. 2026 Jan 27;194(2):254-263. doi: 10.1093/bjd/ljaf398.

  PMID: 41081529 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.

  PMID: 34252397 DERIVED

MeSH Terms

Conditions

Hidradenitis Suppurativa; Inflammation; Skin Diseases

Interventions

vilobelimab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Korinna Pilz, MD, MSc
• Organization: InflaRx N.V.

Korinna.Pilz@InflaRx.de

+49 89 414 189 78 00

Study Officials

• Othmar Zenker, CMO

  InflaRx GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: April 4, 2018
• Study Start: February 26, 2018
• Primary Completion: May 27, 2019
• Study Completion: January 27, 2020
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); BU (3); DE (4); GR (3); US (13); PL (6); FR (6); NL (1); CA (3)