E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Hidradenitis suppurativa is a chronic inflammatory dermatological condition with follicular occlusions that progress to inflammatory lesions. Multiple inflammatory nodules may form dermal abscesses. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020041 |
E.1.2 | Term | Hidradenitis suppurativa |
E.1.2 | System Organ Class | 100000004858 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of imsidolimab in subjects with Hidradenitis suppurativa |
|
E.2.2 | Secondary objectives of the trial |
• To evaluate the safety of imsidolimab in subjects with Hidradenitis suppurativa • To evaluate the effect of imsidolimab on HS signs and symptoms in subjects with Hidradenitis suppurativa |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female aged 18 to 75 years (inclusive) at the time of signing informed consent. 2. Clinically confirmed diagnosis of active HS with a disease duration of ≥ 6 months before Day 1 as determined by the Investigator through subject interview and/or review of the medical history. 3. HS lesions present in at least 2 distinct anatomical areas, 1 of which must be Hurley Stage II (ie, single or multiple, widely separated, recurrent abscesses with tract formation and cicatrization) or Hurley Stage III (ie, diffuse or neardiffuse involvement, or multiple interconnected tracts and abscesses across the entire area). 4. Total AN count ≥ 5 5. Draining fistulas ≤ 20. 6. Stable HS for at least 6 weeks prior to Day 1 visit as determined by the Investigator through subject interview and review of medical history. 7. Agree to daily use (and throughout the study) of one of the following overthe counter topical treatments on their body areas affected with HS lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, dilute bleach in bathwater, or soap and water. 8. Meet the following laboratory criteria at screening: a) Hemoglobin ≥ 90 g/L (≥ 9 g/dL) b) White blood cell count ≥ 3.0 × 109/L (≥ 3.0 × 103/µL) c) Platelets ≥ 100 × 109/L (≥ 100 × 103/µL) d) Serum creatinine <132.6 µmol/L (< 1.5 mg/dL) e) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 upper limit of normal (ULN) f) Total bilirubin ≤ 1.5 × ULN. Subjects with known Gilbert’s disease who have serum bilirubin < 3 × ULN may be included 9. Body weight ≥ 40 kg. 10. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for subjects participating in clinical studies. Contraception and Pregnancy: a) A male subject, who has not had a vasectomy must agree to use contraception during the treatment period and for at least 220 days (which includes the duration of relevant exposure plus the duration of sperm cycle) after the last study treatment administration and refrain from donating sperm during this period. b) Female subjects: i) A woman of childbearing potential (WOCBP) is eligible to participate if she has a negative serum pregnancy test (β-human chorionic gonadotropin) at screening and a negative urine pregnancy test at Day 1, is not breastfeeding, and agrees to follow the contraceptive guidance in the Protocol during the treatment period and for at least 6 months after receiving the study treatment, and refrains from donating oocytes for assisted reproduction during this period. The female subject’s selected form of contraception must be effective by the time the female subject enters into the study at Day 1 (eg, hormonal contraception should be initiated at least 12 Weeks before Day 1. For WOCBP, hormonal contraceptives must be used without schedule changes and in steady doses during the study treatment. Starting hormonal contraceptives during the study is not permitted. Use of any hormonal contraceptives containing drospirenone, chlormadinone acetate, or cyproterone acetate is prohibited unless part of a stable contraceptive regimen ii) A woman not of childbearing potential is eligible to participate in the study. A postmenopausal woman must have a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential. 11. Willing to participate and capable of giving written informed consent, which must be personally signed and dated by the subject and obtained prior to any trial-related activities. 12. Willing to comply with all study procedures and available for the duration of the study. |
|
E.4 | Principal exclusion criteria |
1. Concomitant dermatological or medical conditions that may interfere with the Investigators’ ability to evaluate the subject’s response to therapy. 2. History of clinically significant cardiac, pulmonary, neurologic, gastrointestinal, endocrine, hematological, renal, hepatic, cerebral or psychiatric disease, or other major uncontrolled disease. 3. Chronic or recurrent infectious disease, including upper and lower respiratory infection, urinary tract infection, within 6 months prior to screening. 4. Any evidence of active infection that required treatment with a systemic antibiotic, antiviral, or antifungal agent within 4 weeks of Day 1 excluding localized oral or genital herpes simplex that, in the opinion of the Investigator, is well-controlled. 5. Any factors that would predispose the subject to develop an infection in the Investigator’s opinion. 6. Opportunistic infection or mycobacteria other than tuberculosis [TB]) or parasitic infections within 6 months prior to screening. 7. Herpes zoster infection within 2 months prior to screening. 8. [intentionally blank] 9. Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject’s immune status. 10. Major surgery within 4 weeks of Day 1. 11. History of cancer or lymphoproliferative disease within 5 years of Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded. 12. History of any significant drug allergy or reaction to polysorbate-20, a component of imsidolimab formulation, or the inactive ingredients (excipients). 13. Any systemic antibiotic treatment for HS within 4 weeks of Day 1. 14. Prescription topical therapies for the treatment of HS within 2 weeks of Day 1. 15. Over-the-counter topical antiseptic washes, creams, soaps, ointments, gels, and liquids containing antibacterial agents to treat HS within 2 weeks prior to Day 1. 16. Systemic non-biologic therapies with potential therapeutic impact for HS within 4 weeks of Day 1, including methotrexate (MTX), cyclosporine, retinoids, and fumaric acid esters, and oral or injectable corticosteroids 17. Oral analgesics (including opioids) within 2 weeks of Day 1, unless a subject is on a stable dose (as needed [PRN] is not considered a stable dose) of non-opioid analgesics for a non-HS medical condition, and is stable for 2 weeks prior to Baseline and is anticipated to remain stable throughout study participation. 18. Subject requires or is expected to require opioid analgesics during the study for any reason. 19. Nonbiologic investigational drug within 4 weeks or 5 half-lives of Day 1, whichever is longer. 20. Biologics for at least 12 weeks or 5 half-lives prior to Day 1 21. Live or live-attenuated vaccines within 12 weeks prior to Day 1. Live and live-attenuated vaccines may be utilized 12 weeks after the last study treatment administration. Note: Currently authorized nonlive and nonlive-attenuated vaccines for Coronavirus Disease 2019 (COVID-19) are allowed during the study. 22. Surgical, laser, or intense pulsed light (IPL) intervention in area with HS lesion within 4 weeks prior to Day 1. 23. Phototherapy (psoralen and ultraviolet A [PUVA] and/or UVB) within 4 weeks prior to Day 1 24. Active TB or latent TB infection as indicated by a positive QuantiFERON®-TB Gold test at screening (if the test is indeterminate, it can be repeated only once), chest Xray, and/or clinical examination, or has had active TB disease at any time in the past. 25. Clinically significant drug or alcohol abuse in the last year prior to Day 1, or other factors limiting the ability to cooperate and to comply with the study protocol. 26. Subject is a pregnant or lactating woman, or a woman who intends to become pregnant during the study period. 27. Any other physical, mental, or medical conditions, which make study participation inadvisable or could confound study assessments. 28. Clinically significant abnormality on chest X-ray at screening or within 6 months prior to screening. 29. Positive blood screen for hepatitis C antibody and hepatitis C RNA, antibodies to hepatitis B core antigen, hepatitis B surface antigen, or human immunodeficiency virus 1 and 2 antibodies. 30. Subject is not able to tolerate SC drug administration. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from Baseline in AN count at Week 16 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Incidence of AEs, SAEs, and AEs leading to treatment discontinuation, as well as changes in vital signs, clinical laboratory parameters (hematology, biochemistry, and urinalysis), and 12-lead ECGs • Percent change from Baseline in AN count at Week 16 • Proportion of subjects achieving HiSCR50 at Week 16 • Change from Baseline in HS Pain NRS at Week 16 • Percent change from Baseline in HS Pain NRS at Week 16
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
To test for immunogenicity to imsidolimab |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
United States |
Georgia |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 14 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 17 |