Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa (HS) Drug: IFX-1 Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 26, 2018
Actual Primary Completion Date : May 28, 2019
Estimated Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Cohort 1
Placebo
Drug: Placebo
Placebo

Experimental: Cohort 2
Minimum Dose IFX-1
Drug: IFX-1
Single IV infusions of IFX-1 diluted in sodium chloride.
Other Name: CaCP29

Experimental: Cohort 3
Low dose IFX-1
Drug: IFX-1
Single IV infusions of IFX-1 diluted in sodium chloride.
Other Name: CaCP29

Experimental: Cohort 4
Medium Dose IFX-1
Drug: IFX-1
Single IV infusions of IFX-1 diluted in sodium chloride.
Other Name: CaCP29

Experimental: Cohort 5
High Dose IFX-1
Drug: IFX-1
Single IV infusions of IFX-1 diluted in sodium chloride.
Other Name: CaCP29




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

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): NCT03487276


  Show 41 Study Locations
Sponsors and Collaborators
InflaRx GmbH
Quintiles, Inc.
Investigators
Layout table for investigator information
Study Director: Othmar Zenker, CMO InflaRx GmbH

Layout table for additonal information
Responsible Party: InflaRx GmbH
ClinicalTrials.gov Identifier: NCT03487276     History of Changes
Other Study ID Numbers: IFX-1-P2.4
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by InflaRx GmbH:
hidradenitis suppurativa
monoclonal antibody
complement factor C5a
IFX-1
hidradenitis Suppurativa Clinical Response
Inflammation
skin diseases

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