Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa

September 15, 2017 updated by: InflaRx GmbH

An Open Label Phase II Trial to Evaluate the Safety of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa

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)).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 12462
        • Attikon University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Body weight above 150 kg or body weight below 60 kg
  2. Has a draining fistula count of greater than 30 at baseline
  3. Surgical management planned within the next 24 weeks
  4. Occurrence of a flare-up of HS leading to intravenous antimicrobial treatment within the last 14 days

  5. Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study

    1. Active infection
    2. Severe congestive heart failure (i.e., New York Heart Association (NYHA) Class IV)
    3. Depression
    4. History of systemic lupus erythematosus or rheumatoid arthritis
    5. Any immunodeficiency disease
    6. Active hematological or solid malignant tumor
    7. 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.

  6. One of the following abnormal laboratory results

    1. White blood cell count < 2,500/mm3
    2. Neutrophil count < 1000/mm3
    3. Serum Creatinine > 3 x Upper Normal Limit (UNL)
    4. Total Bilirubin > 2 x UNL
    5. Alanine-Aminotransferase (ALAT) > 2 x UNL
    6. Positive screening test for Hepatitis B, Hepatitis C, or HIV 1/2
  7. Prior administration of any biological compound in the last 3 months
  8. Intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1 mg/kg for the last three weeks;
  9. Intake of Immunosuppressive drugs within past 30 days (e.g., cyclosporine, tacrolimus)

  10. General exclusion criteria

    1. Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
    2. Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial
    3. Participation in any interventional clinical trial within the last three months
    4. Known intravenous drug abuse
    5. Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: IFX-1
Biological: IFX-1
chimeric, monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of patients with at least possibly related treatment-emergent adverse events (TEAEs)
Time Frame: up to Day 134
up to Day 134
Number of patients with detection of anti-drug antibodies (pre-/post-dosing)
Time Frame: up to Day 134
up to Day 134

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Plasma concentration of IFX-1
Time Frame: From Day 1 until Day 134
From Day 1 until Day 134
Plasma concentration of C5a
Time Frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
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
Time Frame: Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
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
Time Frame: Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
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
Time Frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
HS-PGA score per time point
Time Frame: Data will be collected at the following time points: Day 1, 22, 29, 36, 43, 50, 78, 106 and Day 134
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
Time Frame: At each visit from Day 1 until Day 134
At each visit from Day 1 until Day 134
VAS pain score per time point
Time Frame: At each visit from Day 1 until Day 134
At each visit from Day 1 until Day 134
Change from baseline in VAS pain score per time point
Time Frame: At each visit from Day 1 until Day 134
At each visit from Day 1 until Day 134
VAS disease score per time
Time Frame: At each visit from Day 1 until Day 134
At each visit from Day 1 until Day 134
Change from baseline in VAS disease score per time point
Time Frame: At each visit from Day 1 until Day 134
At each visit from Day 1 until Day 134
Dermatology Life Quality Index (DLQI) per time point
Time Frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
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
Time Frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InflaRx GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IFX-1-P2.3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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