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Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa

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ClinicalTrials.gov Identifier: NCT03001622
Recruitment Status : Completed
First Posted : December 23, 2016
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
InflaRx GmbH

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)).

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Biological: IFX-1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase II Trial to Evaluate the Safety of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa
Actual Study Start Date : December 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
IFX-1 Biological: IFX-1
chimeric, monoclonal antibody




Primary Outcome Measures :
  1. Number of patients with at least possibly related treatment-emergent adverse events (TEAEs) [ Time Frame: up to Day 134 ]
  2. Number of patients with detection of anti-drug antibodies (pre-/post-dosing) [ Time Frame: up to Day 134 ]

Secondary Outcome Measures :
  1. Plasma concentration of IFX-1 [ Time Frame: From Day 1 until Day 134 ]
  2. Plasma concentration of C5a [ Time Frame: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. VAS pain score per time point [ Time Frame: At each visit from Day 1 until Day 134 ]
  9. Change from baseline in VAS pain score per time point [ Time Frame: At each visit from Day 1 until Day 134 ]
  10. VAS disease score per time [ Time Frame: At each visit from Day 1 until Day 134 ]
  11. Change from baseline in VAS disease score per time point [ Time Frame: At each visit from Day 1 until Day 134 ]
  12. 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 ]
  13. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001622


Locations
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Greece
ATTIKON University Hospital
Athens, Greece, 12462
Sponsors and Collaborators
InflaRx GmbH

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Responsible Party: InflaRx GmbH
ClinicalTrials.gov Identifier: NCT03001622     History of Changes
Other Study ID Numbers: IFX-1-P2.3
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration