Hidradenitis suppurativa (HS) MedDRA version: 20.0 Level: LLT Classification code 10020041 Term: Hidradenitis suppurativa System Organ Class: 100000004858
Conditions
Sponsors
InflaRx GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, = 18 years of age 2. Written informed consent obtained from subject 3. Diagnosis of Hidradentis Suppurativa (HS) for at least 1 year 4. 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 5. Stable HS for at least 2 months before Screening, as determined by the investigator through subject interview and review of medical history 6. Inadequate response to at least 3 months of oral antibiotics, or intolerance to antibiotics 7. Total abscess and inflammatory nodule count of = 3 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 167 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Body weight 130 kg 2. Any other skin disease that may interfere with assessment of HS 3. More than 20 draining fistulas 4. Prior treatment with adalimumab or another biologic product during the 24 weeks before Screening 5. Prior treatment with IFX-1 6. 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 7. 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) 8. Prior treatment with any of the following medications during the 28 days before Screening: a. Any other systemic therapy for HS b. Any iv anti-infective therapy c. Phototherapy (UVB or psoralen and UVA) 9. Prior treatment with any of the following medications during the 14 days before Screening: a. Analgesics (including opioids) for HS related pain b. Prescription-only topical therapies for HS c. Oral anti-infectives for infections other than HS 10. History of moderate to severe heart failure (New York Heart Association Class III or IV), cerebrovascular accident during the 24 weeks before Screening, history of malignancy except for successfully treated non-metastatic basal cell or squamous cell carcinoma or in situ carcinoma of the cervix 11. One of the following abnormal laboratory findings: a. White blood cell count (WBC) 3 × UNL d. Total bilirubin > 3 × UNL e. Alanine aminotransferase > 5 × UNL f. Aspartate aminotransferase > 5 × UNL g. Positive Screening test for HIV-1 or 2, or hepatitis B or C virus 12. Chronic and/or recurring systemic infections, history of invasive infections with atypical pathogens (i.e., which normally do not cause invasive infection, such as listeriosis), or known primary immunodeficiency 13. Subject is judged to be in poor general health, as determined by the investigator based upon medical history, physical examination, laboratory safety and, a 12 lead ECG 14. Female subjects of childbearing potential unwilling or unable to use a highly effective method of contraception (pearl index < 1%) such as complete sexual abstinence, combined oral contraceptive, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant, or depot contraceptive injection in combination with a second method of contraception such as condom, cervical cap, or diaphragm with spermicide during the study and for at least 1 month after last administration of IMP 15. History of drug or alcohol abuse during the 24 weeks before Screening 16. Pregnancy, as verified by a positive pregnancy test, or nursing woman 17. Evidence or suspicion that the subject might not comply with the requirements of the study protocol 18. Any other factor which, in the investigator’s opinion, is likely to compromise the subject’s ability to participate in the study 19. The subject is an employee or direct relative of an employee at the study site or sponsor 20. The subject is imprisoned or lawfully kept in an institution 21. The subject has participated in a clinical study during the 3 months before Screening, or plans to participate in a clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate a dose-response signal of IFX-1 in subjects with moderate to severe hidradenitis suppurativa according to the Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16. ;Secondary Objective: • To assess the efficacy of IFX-1 using additional outcome measures • To assess the safety and tolerability of IFX-1 • To generate data for pharmacokinetics (PK) and pharmacodynamics (PD) modelling • To assess patient-reported outcomes • To evaluate the long-term efficacy and safety of IFX-1 ;Primary end point(s): The primary efficacy endpoint is the percentage of subjects with a response on the basis of the HiSCR determined at Week 16, before administration of IMP.;Timepoint(s) of evaluation of this end point: Week 16 (before administration of the IMP) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: 1. Percentage of subjects with a response on the basis of the HiSCR determined at Week 12, before administration of IMP 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 3. Absolute values and absolute and relative change in modified Sartorius Score (mSS) from Day 1 by time point 4. Absolute value and absolute and relative change in Patient’s Global Assessment of Skin Pain (Numeric Rating Scale [NRS]) from Day 1 by time point 5. Percentage of subjects achieving, by time point: - At least a 30% reduction and at least 1 unit reduction from Day 1 among subjects with baseline NRS = 3 in Patient’s Global Assessment of Skin Pain (NRS30) - At least a 50% reduction and at least 2 units reduction from Day 1 among subjects with baseline NRS = 3 in Patient’s Global Assessment of Skin Pain (NRS50) 6. Absolute values and absolute and relative change in Dermatology Life Quality Index (DLQI) score from Day 1 by time point Safety endpoints: 7. The number and percentage of subjects who had a treatment-emergent adverse event (TEAE) as well as the number of TEAEs will be assessed for all TEAEs and serious adverse events (SAEs). ;Timepoint(s) of evaluation of this end point: 1. Week 12 (before administration of the IMP) 2. and 3. At weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44 for all patients, and in addition for HiSCR non-responders: at weeks 22, 26, 30, 34, 38 4. and 5. Daily from Day 0 to week 44 6. At weeks 16, 32, 44 7. Continuously from screening to end of study (week 44) | — |
Countries
Bulgaria, Canada, Denmark, France, Germany, Greece, Netherlands, Poland, United States
Contacts
Public ContactInflaRx GmbH
InflaRx GmbH
Outcome results
None listed