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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Are there results?
None posted in the registry

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.

Greece1 site

  • ATTIKON University Hospital

    Athens, 12462

Other trials in Greece

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)).

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 groups in NCT03001622
Study groupRoleWhat they receive
IFX-1OtherNot described
Receives: Biological: IFX-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with at least possibly related treatment-emergent adverse events (TEAEs)

    Measured: up to Day 134

  2. Number of patients with detection of anti-drug antibodies (pre-/post-dosing)

    Measured: up to Day 134

Secondary outcomes (13)

  1. Plasma concentration of IFX-1

    Measured: From Day 1 until Day 134

  2. Plasma concentration of C5a

    Measured: Data will be collected at the following time points: Day 1, Day 22, Day 50 and Day 134

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. VAS pain score per time point

    Measured: At each visit from Day 1 until Day 134

  9. Change from baseline in VAS pain score per time point

    Measured: At each visit from Day 1 until Day 134

  10. VAS disease score per time

    Measured: At each visit from Day 1 until Day 134

  11. Change from baseline in VAS disease score per time point

    Measured: At each visit from Day 1 until Day 134

  12. 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

  13. 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.

  1. First posted23 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IFX-1 in people with Hidradenitis Suppurativa, run by InflaRx GmbH at 1 site in Greece.

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 7 inclusion and 28 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 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 at least possibly related treatment-emergent adverse events (TEAEs) (time frame: up to Day 134). The study lists 2 primary outcomes in all. 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 NCT03001622, which also lists 1 linked publication.

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 19 Sep 2017.

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Clinical Trial NCT03001622 | AzTrials