Hidradenitis Suppurativa (HS)Phase 2SHINENCT03487276
Efficacy and Safety Study of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
A Phase 2 study testing IFX-1 in people with Hidradenitis Suppurativa (HS), run by InflaRx GmbH at 41 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- IFX-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 41 sitesin 9 countries
- Study dates
- 26 Feb 2018to 27 Jan 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 (ultraviolet B or psoralen and ultraviolet A)
- History of heart disease or malignancy
Trial locations and contacts
41 sites in 9 countries.
41 sites in 9 countries
United States13 sites
InflaRX Investigational Site
Birmingham, Alabama, 35233
InflaRX Investigational Site
Chapel Hill, North Carolina, 27516
InflaRX Investigational Site
Cincinnati, Ohio, 45219
InflaRX Investigational Site
Columbia, Missouri, 65212
InflaRX Investigational Site
Dearborn, Michigan, 48124
InflaRX Investigational Site
Fort Myers, Florida, 33912
InflaRx Investigational Site
Goodlettsville, Tennessee, 37072
InflaRX Investigational Site
Hershey, Pennsylvania, 17033
InflaRX Investigational Site
Miami, Florida, 33136
InflaRx Investigational Site
Saint Joseph, Missouri, 64506
InflaRX Investigational Site
Sandy Springs, Georgia, 30328
InflaRX Investigational Site
St Louis, Missouri, 63104
InflaRX Investigational Site
St Louis, Missouri, 63110
France6 sites
InflaRX Investigational Site
Antony, Hauts De Seine, 92160
InflaRX Investigational Site
Bordeaux, Gironde, 33000
InflaRX Investigational Site
Nantes, Loire Atlantique, 44093
InflaRX Investigational Site
Nice, Alpes Maritimes, 06202
InflaRX Investigational Site
Paris, 75475
InflaRX Investigational Site
Toulouse, Haute Garonne, 31059
Poland6 sites
InflaRX Investigational Site
Gdansk, 80-402
InflaRX Investigational Site
Kłodzko, 57-300
InflaRX Investigational Site
Krakow, 30-033
InflaRX Investigational Site
Lodz, 90-436
InflaRX Investigational Site
Wroclaw, 50-566
InflaRX Investigational Site
Wroclaw, 51-318
Germany4 sites
InflaRX Investigational Site
Bochum, North Rhine-Westphalia, 44791
InflaRX Investigational Site
Darmstadt, Hesse, 64297
InflaRX Investigational Site
Dessau, Saxony-Anhalt, 06847
InflaRX Investigational Site
Frankfurt am Main, Hesse, 60590
Bulgaria3 sites
InflaRX Investigational Site
Sofia, 1431
InflaRX Investigational Site
Sofia, 1606
InflaRX Investigational Site
Stara Zagora, 6003
Canada3 sites
InflaRX Investigational Site
Peterborough, Ontario, K9J 5K2
InflaRX Investigational Site
Richmond Hill, Ontario, L4C 9M7
InflaRX Investigational Site
St. John's, Newfoundland and Labrador, A1C 2H5
Greece3 sites
InflaRX Investigational Site
Athens, 115 25
InflaRX Investigational Site
Athens, 12462
InflaRX Investigational Site
Thessaloniki, 54645
Denmark2 sites
InflaRX Investigational Site
Copenhagen, 2400
InflaRX Investigational Site
Roskilde, 4000
About this study
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
The purpose of this study is to determine whether IFX-1 is safe and effective in the treatment of moderate to severe hidradenitis suppurativa.
Read the 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.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- IFX-1, Placebo
- Keywords
- hidradenitis suppurativa, monoclonal antibody, complement factor C5a, IFX-1, hidradenitis Suppurativa Clinical Response, Inflammation, skin diseases
- Medical subject headings
- Hidradenitis Suppurativa, Inflammation, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFX-1Drug
Also called CaCP29, Vilobelimab
Single IV infusions of IFX-1 diluted in sodium chloride.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
| Cohort 2 | Experimental | Minimum Dose IFX-1 (400 mg Q4W) Receives: Drug: IFX-1 |
| Cohort 3 | Experimental | Low dose IFX-1 (800 mg Q4W) Receives: Drug: IFX-1 |
| Cohort 4 | Experimental | Medium Dose IFX-1 (800 mg Q2W) Receives: Drug: IFX-1 |
| Cohort 5 | Experimental | High Dose IFX-1 (1200 mg Q2W) Receives: Drug: IFX-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16
The primary efficacy endpoint of the percentage of patients with HiSCR at Week 16 was analyzed using the multiple comparisons procedure-modelling (MCP-Mod) procedure. The definition for response to treatment based on HiSCR relative to Baseline was: at least 50% reduction in abscesses and inflammatory nodule (AN) count (over all anatomical regions) with no increase in number of abscesses and in number of draining fistulas.
Measured: Week 16
Secondary outcomes (8)
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12
Endpoint of the percentage of patients with HiSCR at Week 12 was analyzed in the same way as the primary endpoint using the MCP-Mod procedure and the same definition of response.
Measured: Week 12
Number of Patients With Flares Relative to Day 1
The number of patients with flares analyzed in terms of ≥ 25% increase in abscess and inflammatory nodule (AN) count among patients with a minimum increase of 2 in AN count compared to Day 1 was analyzed by descriptive statistics by time point.
Measured: From Day 1 until Day 309
Absolute Change in Modified Sartorius Score (mSS) From Day 1.
The absolute change from Day 1 will be analyzed by descriptive statistics by time point. The mSS is a summation of HS lesions based on a number of factors including anatomical region, number and type of lesions, distance between relevant lesions and lesions clearly separated by normal skin in each region measured as HS clinical parameters. The scale title for mSS is points. The mSS has a minimum value of 0 and no upper limit. The higher the score the more severe is the disease/worse is the outcome.
Measured: From Day 1 until Day 309
Absolute Change in Patient's Global Assessment of Skin Pain From Day 1.
The absolute changes from baseline were analyzed by descriptive statistics by time point. The Numeric Rating Scale (NRS) was used to assess the worst skin pain due to HS. The scale title for the NRS is points. Ratings for this item range from a minimum of 0 points (no skin pain) to a maximum of 10 points (skin pain as bad as you can imagine). The higher the score the more severe the disease/worse is the outcome.
Measured: From Day 1 until Day 309
Percentage of Patients Achieving NRS30
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 scale title for the NRS is points. The minimum score is 0 points (No skin pain), and the maximum score is 10 points (Skin pain as bad as you can imagine). The higher the score the more severe is the disease/worse is the outcome. The number of patients with at least 30% reduction and at least 1 point reduction from Day 1 in Patients Global Assessment of Skin Pain are displayed. The analysis is based on the worst skin pain the patients reported at the respective visits.
Measured: From Day 1 until Day 309
Percentage of Patients Achieving NRS50.
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 scale title for NRS is points. The minimum score is 0 points (No skin pain), and the maximum score is 10 points (Skin pain as bad as you can imagine). The higher the score the more severe is the disease/worse is the outcome. The number of patients with at least 50% reduction and at least 1 point reduction from Day 1 in Patients Global Assessment of Skin Pain are displayed. The analysis is based on the worst skin pain the patients reported at the respective visits.
Measured: From Day 1 until Day 309
Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1.
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 scale title for DLQI is points. The total score is the sum of the responses to all 10 DLQI items, ranging from the minimum of 0 points to the maximum of 30 points. A higher score corresponds to worse health related quality of life/outcome.
Measured: From Day 1 until Day 309
Safety Parameters (Adverse Events) Will be Assessed.
The number of patients with any treatment emergent adverse event (adverse events that started after first infusion of IMP) was analyzed by time point.
Measured: From Day 1 until Day 309
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start26 Feb 2018
- Primary completion27 May 2019
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- InflaRx GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Othmar Zenker, CMO, Study director, InflaRx GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487276
- Sponsor's protocol ID
- IFX-1-P2.4
- Acronym
- SHINE
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2018
- Last updated
- 8 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giamarellos-Bourboulis EJ, Jemec GBE, Prens EP, Riedemann NC, Otto I, Weisman J, Pulka G, Nowicki RJ, Kantardjiev V, Pinter A, Thomsen SF, Berneman D, Kanni T, Alavi A, Breno B, Gooderham M, Stone M, Anadkat MJ, Katoulis A, Papakonstantis M, Becherel PA, Szepietowski JC, van der Zee HH, Zouboulis CC, Sayed CJ. Vilobelimab to improve clinical outcomes in moderate-to-severe hidradenitis suppurativa through an adjunctive effect on draining tunnels: results of the SHINE double-blind placebo-controlled randomized trial. Br J Dermatol. 2026 Jan 27;194(2):254-263. doi: 10.1093/bjd/ljaf398.
PubMed 41081529Prens LM, Ardon CB, van Straalen KR, van der Zee HH, Seelen MAJ, Laman JD, Prens EP, Horvath B, Damman J. No Evident Systemic Terminal Complement Pathway Activation in Hidradenitis Suppurativa. J Invest Dermatol. 2021 Dec;141(12):2966-2969.e1. doi: 10.1016/j.jid.2021.03.037. Epub 2021 Jul 9. No abstract available.
PubMed 34252397
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03487276
- Acronym / sponsor ID
- SHINE / IFX-1-P2.4
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- hidradenitis suppurativa, monoclonal antibody, complement factor C5a, IFX-1, hidradenitis Suppurativa Clinical Response, Inflammation, skin diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- InflaRx GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Placebo comparator | Drug: PlaceboPlacebo |
| Cohort 2 | Experimental | Drug: IFX-1Minimum Dose IFX-1 (400 mg Q4W) |
| Cohort 3 | Experimental | Drug: IFX-1Low dose IFX-1 (800 mg Q4W) |
| Cohort 4 | Experimental | Drug: IFX-1Medium Dose IFX-1 (800 mg Q2W) |
| Cohort 5 | Experimental | Drug: IFX-1High Dose IFX-1 (1200 mg Q2W) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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:
- History of heart disease or malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IFX-1Also: CaCP29, VilobelimabSingle IV infusions of IFX-1 diluted in sodium chloride. | Drug | Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| PlaceboPlacebo | Drug | Cohort 1 |
Primary outcome
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16
Time frame: Week 16
The primary efficacy endpoint of the percentage of patients with HiSCR at Week 16 was analyzed using the multiple comparisons procedure-modelling (MCP-Mod) procedure. The definition for response to treatment based on HiSCR relative to Baseline was: at least 50% reduction in abscesses and inflammatory nodule (AN) count (over all anatomical regions) with no increase in number of abscesses and in number of draining fistulas.
8 secondary outcomes
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 12
Time frame: Week 12
Number of Patients With Flares Relative to Day 1
Time frame: From Day 1 until Day 309
Absolute Change in Modified Sartorius Score (mSS) From Day 1.
Time frame: From Day 1 until Day 309
Absolute Change in Patient's Global Assessment of Skin Pain From Day 1.
Time frame: From Day 1 until Day 309
Percentage of Patients Achieving NRS30
Time frame: From Day 1 until Day 309
Percentage of Patients Achieving NRS50.
Time frame: From Day 1 until Day 309
Absolute Change in Dermatology Life Quality Index (DLQI) Score From Day 1.
Time frame: From Day 1 until Day 309
Safety Parameters (Adverse Events) Will be Assessed.
Time frame: From Day 1 until Day 309
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41081529Giamarellos-Bourboulis EJ, Jemec GBE, Prens EP, Riedemann NC, Otto I, Weisman J, Pulka G, Nowicki RJ, Kantardjiev V, Pinter A, Thomsen SF, Berneman D, Kanni T, Alavi A, Breno B, Gooderham M, Stone M, Anadkat MJ, Katoulis A, Papakonstantis M, Becherel PA, Szepietowski JC, van der Zee HH, Zouboulis CC, Sayed CJ. Vilobelimab to improve clinical outcomes in moderate-to-severe hidradenitis suppurativa through an adjunctive effect on draining tunnels: results of the SHINE double-blind placebo-controlled randomized trial. Br J Dermatol. 2026 Jan 27;194(2):254-263. doi: 10.1093/bjd/ljaf398.
- Derived from this study: PubMed 34252397Prens LM, Ardon CB, van Straalen KR, van der Zee HH, Seelen MAJ, Laman JD, Prens EP, Horvath B, Damman J. No Evident Systemic Terminal Complement Pathway Activation in Hidradenitis Suppurativa. J Invest Dermatol. 2021 Dec;141(12):2966-2969.e1. doi: 10.1016/j.jid.2021.03.037. Epub 2021 Jul 9. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Othmar Zenker, CMO study director
InflaRx GmbH
41 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IFX-1 in people with Hidradenitis Suppurativa (HS), run by InflaRx GmbH at 41 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, France, Poland, Germany, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Hidradenitis Suppurativa Clinical Response (HiSCR) Determined at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03487276, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.