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

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ClinicalTrials.gov Identifier: NCT03487276
Recruitment Status : Active, not recruiting
First Posted : April 4, 2018
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
InflaRx GmbH

Tracking Information
First Submitted Date  ICMJE February 27, 2018
First Posted Date  ICMJE April 4, 2018
Last Update Posted Date June 26, 2019
Actual Study Start Date  ICMJE February 26, 2018
Actual Primary Completion Date May 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
Response on the basis of the Hidradenitis Suppurativa Clinical Response (HiSCR) determined at Week 16 [ Time Frame: Week 16 ]
The primary efficacy endpoint of the percentage of subjects with HiSCR at Week 16 will be analyzed using the multiple comparisons procedure-modelling (MCP-Mod) procedure.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03487276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • Percentage of subjects with a response on the basis of the HiSCR determined at Week 12 [ Time Frame: Week 12 ]
    Endpoint of the percentage of subjects with HiSCR at Week 12 will be analyzed in the same way as the primary endpoint using the MCP-Mod procedure.
  • Number of subjects with flares analyzed in terms of ≥ 25% increase in AN count among subjects with a minimum increase of 2 in AN count relative to Day 1 [ Time Frame: From Day 1 until Day 309 ]
    The number of subjects with flares compared to Day 1 will be analyzed by descriptive statistics by time point.
  • Change in modified Sartorius Score (mSS) from Day 1 by time point [ Time Frame: From Day 1 until Day 309 ]
    The changes from Day 1 will be analyzed by descriptive statistics by time point. The NRS will be used to assess the worst and average skin pain due to HS. Ratings for these 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).
  • Change in Patient's Global Assessment of Skin Pain (Numeric Rating Scale [NRS]) from Day 1 by time point [ Time Frame: From Day 1 until Day 309 ]
    The absolute values and changes from baseline will be analyzed by descriptive statistics by time point. The NRS will be used to assess the worst and average skin pain due to HS. Ratings for these 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).
  • Percentage of subjects achieving, by time point: At least a 30% reduction and at least 1 unit reduction from Day 1 in Patient's Global Assessment of Skin Pain (NRS30) [ Time Frame: From Day 1 until Day 309 ]
    This is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10) that best reflects the intensity of their pain. The minimum score is 0 (No skin pain), and the maximum score is 10 (Skin pain as bad as you can imagine). There are no sub-scales. All categorical efficacy endpoints will be summarized by time point using absolute and relative frequencies.
  • Percentage of subjects achieving, by time point: At least a 50% reduction and at least 1 unit reduction from Day 1 in Patient's Global Assessment of Skin Pain (NRS50) [ Time Frame: From Day 1 until Day 309 ]
    This is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10) that best reflects the intensity of their pain. The minimum score is 0 (No skin pain), and the maximum score is 10 (Skin pain as bad as you can imagine). There are no sub-scales. All categorical efficacy endpoints will be summarized by time point using absolute and relative frequencies.
  • Change in Dermatology Life Quality Index (DLQI) score from Day 1 by time point [ Time Frame: From Day 1 until Day 309 ]
    The changes from Day 1 will be analyzed by descriptive statistics by time point. A score is documented for each of the 10 DLQI items, ranging from 0 to 3 for each item. The total score is the sum of the responses to all 10 DLQI items, ranging from 0 to 30. A higher score corresponds to worse health related quality of life
  • Safety parameters (adverse events) will be assessed. [ Time Frame: From Day 1 until Day 309 ]
    Continuous safety parameters will be analyzed by descriptive statistics by time point.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
  • Percentage of subjects with a response on the basis of the HiSCR determined at Week 12 [ Time Frame: Week 12 ]
    Endpoint of the percentage of subjects with HiSCR at Week 12 will be analyzed in the same way as the primary endpoint using the MCP-Mod procedure.
  • Number of subjects with flares analyzed in terms of ≥ 25% increase in AN count among subjects with a minimum increase of 2 in AN count relative to Day 1 [ Time Frame: From Day 1 until Day 309 ]
    The number of subjects with flares compared to Day 1 will be analyzed by descriptive statistics by time point.
  • Change in modified Sartorius Score (mSS) from Day 1 by time point [ Time Frame: From Day 1 until Day 309 ]
    The changes from Day 1 will be analyzed by descriptive statistics by time point. The NRS will be used to assess the worst and average skin pain due to HS. Ratings for these 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).
  • Change in Patient's Global Assessment of Skin Pain (Numeric Rating Scale [NRS]) from Day 1 by time point [ Time Frame: From Day 1 until Day 309 ]
    The absolute values and changes from baseline will be analyzed by descriptive statistics by time point. The NRS will be used to assess the worst and average skin pain due to HS. Ratings for these 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).
  • Percentage of subjects achieving, by time point: At least a 30% reduction and at least 1 unit reduction from Day 1 in Patient's Global Assessment of Skin Pain (NRS30) [ Time Frame: From Day 1 until Day 309 ]
    All categorical efficacy endpoints will be summarized by time point using absolute and relative frequencies.
  • Percentage of subjects achieving, by time point: At least a 50% reduction and at least 1 unit reduction from Day 1 in Patient's Global Assessment of Skin Pain (NRS50) [ Time Frame: From Day 1 until Day 309 ]
    All categorical efficacy endpoints will be summarized by time point using absolute and relative frequencies.
  • Change in Dermatology Life Quality Index (DLQI) score from Day 1 by time point [ Time Frame: From Day 1 until Day 309 ]
    The changes from Day 1 will be analyzed by descriptive statistics by time point. A score is documented for each of the 10 DLQI items, ranging from 0 to 3 for each item. The total score is the sum of the responses to all 10 DLQI items, ranging from 0 to 30. A higher score corresponds to worse health related quality of life
  • Safety parameters (adverse events) will be assessed. [ Time Frame: From Day 1 until Day 309 ]
    Continuous safety parameters will be analyzed by descriptive statistics by time point.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Determine Efficacy and Safety of IFX-1 in Subjects With Moderate to Severe Hidradenitis Suppurativa
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.
Detailed Description Hidradenitis suppurativa (HS) is a chronic devastating skin disorder affecting areas rich in apocrine glands. HS is diagnosed by its clinical features and its chronicity. It is recognized by the presence of recurrent, painful, deep-seated, rounded nodules usually ending in abscesses and sinus tracts with suppuration and hypertrophic scarring. As complement C5a is involved in the underlying acute inflammatory responses, this study is set up based on the hypothesis that IFX-1 might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hidradenitis Suppurativa (HS)
Intervention  ICMJE
  • Drug: IFX-1
    Single IV infusions of IFX-1 diluted in sodium chloride.
    Other Name: CaCP29
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: Cohort 1
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Cohort 2
    Minimum Dose IFX-1
    Intervention: Drug: IFX-1
  • Experimental: Cohort 3
    Low dose IFX-1
    Intervention: Drug: IFX-1
  • Experimental: Cohort 4
    Medium Dose IFX-1
    Intervention: Drug: IFX-1
  • Experimental: Cohort 5
    High Dose IFX-1
    Intervention: Drug: 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2018)
175
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 10, 2019
Actual Primary Completion Date May 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 (ultra-violet B [UVB] or psoralen and ultra-violet A [UVA])
  • History of heart disease or malignancy
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 Bulgaria,   Canada,   Denmark,   France,   Germany,   Greece,   Netherlands,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03487276
Other Study ID Numbers  ICMJE IFX-1-P2.4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party InflaRx GmbH
Study Sponsor  ICMJE InflaRx GmbH
Collaborators  ICMJE Quintiles, Inc.
Investigators  ICMJE
Study Director: Othmar Zenker, CMO InflaRx GmbH
PRS Account InflaRx GmbH
Verification Date June 2019

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