Hidradenitis SuppurativaPhase 2NCT03001622
Studying Complement Inhibition in Patients With Moderate to Severe Hidradenitis Suppurativa
A Phase 2 study testing IFX-1 in people with Hidradenitis Suppurativa, run by InflaRx GmbH at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- IFX-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2016to Jul 2017
- Phase
- Phase 2
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 patients ≥ 18 years old
- Written informed consent
- Diagnosis of HS for at least 1 year
- Hidradenitis suppurativa (HS) lesions in at least 2 distinct anatomic areas, one of which is Hurley Stage II or III
- Total AN (abscesses and nodules) count ≥3
- Patients with either primary or secondary failure of biological treatment or are not eligible for treatment with other biologicals
- Failure of previous antimicrobial treatments
Who cannot join
- Body weight above 150 kg or body weight below 60 kg
- Has a draining fistula count of greater than 30 at baseline
- Surgical management planned within the next 24 weeks
- Occurrence of a flare-up of HS leading to intravenous antimicrobial treatment within the last 14 days
- Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study
- Active infection
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- Severe congestive heart failure (i.e., New York Heart Association (NYHA) Class IV)
- Depression
- History of systemic lupus erythematosus or rheumatoid arthritis
- Any immunodeficiency disease
- Active hematological or solid malignant tumor
- 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.
- One of the following abnormal laboratory results
- White blood cell count < 2,500/mm3
- Neutrophil count < 1000/mm3
- Serum Creatinine > 3 x Upper Normal Limit (UNL)
- Total Bilirubin > 2 x UNL
- Alanine-Aminotransferase (ALAT) > 2 x UNL
- Positive screening test for Hepatitis B, Hepatitis C, or HIV 1/2
- Prior administration of any biological compound in the last 3 months
- Intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1 mg/kg for the last three weeks;
- Intake of Immunosuppressive drugs within past 30 days (e.g., cyclosporine, tacrolimus)
- General exclusion criteria
- Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
- 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
- Participation in any interventional clinical trial within the last three months
- Known intravenous drug abuse
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Phase II Trial to Evaluate the Safety of IFX-1 in Patients With Moderate to Severe Hidradenitis Suppurativa
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)).
- Conditions
- Hidradenitis Suppurativa
- Being tested
- IFX-1
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFX-1Biological
chimeric, monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| IFX-1 | Other | Not described Receives: Biological: IFX-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with at least possibly related treatment-emergent adverse events (TEAEs)
Measured: up to Day 134
Number of patients with detection of anti-drug antibodies (pre-/post-dosing)
Measured: up to Day 134
Secondary outcomes (13)
Plasma concentration of IFX-1
Measured: From Day 1 until Day 134
Plasma concentration of C5a
Measured: 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
Measured: 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
Measured: 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
Measured: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
HS-PGA score per time point
Measured: 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
Measured: At each visit from Day 1 until Day 134
VAS pain score per time point
Measured: At each visit from Day 1 until Day 134
Change from baseline in VAS pain score per time point
Measured: At each visit from Day 1 until Day 134
VAS disease score per time
Measured: At each visit from Day 1 until Day 134
Change from baseline in VAS disease score per time point
Measured: At each visit from Day 1 until Day 134
Dermatology Life Quality Index (DLQI) per time point
Measured: 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
Measured: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- InflaRx GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001622
- Sponsor's protocol ID
- IFX-1-P2.3
- Status last verified
- Sep 2017
- First submitted
- 29 Nov 2016
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Prens 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