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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

Tracking Information
First Submitted Date  ICMJE November 29, 2016
First Posted Date  ICMJE December 23, 2016
Last Update Posted Date September 19, 2017
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
  • Number of patients with at least possibly related treatment-emergent adverse events (TEAEs) [ Time Frame: up to Day 134 ]
  • Number of patients with detection of anti-drug antibodies (pre-/post-dosing) [ Time Frame: up to Day 134 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03001622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
  • Plasma concentration of IFX-1 [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • VAS pain score per time point [ Time Frame: 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 ]
  • VAS disease score per time [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa
Official Title  ICMJE An Open Label Phase II Trial to Evaluate the Safety of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa
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)).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa
Intervention  ICMJE Biological: IFX-1
chimeric, monoclonal antibody
Study Arms  ICMJE IFX-1
Intervention: Biological: IFX-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 20, 2016)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03001622
Other Study ID Numbers  ICMJE IFX-1-P2.3
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party InflaRx GmbH
Study Sponsor  ICMJE InflaRx GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InflaRx GmbH
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP