Status:
COMPLETED
A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa.
Lead Sponsor:
Aarhus University Hospital
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
This is a 16-week treatment, randomized, double-blind, proof-of-concept study designed to assess the safety and efficacy of RGRN-305 compared to placebo for use in future efficacy Phase 2 trials. Mal...
Eligibility Criteria
Inclusion
- Subjects will be eligible to be enrolled in the study if they meet all of the following criteria at the Screening and Baseline (Day 0) Visits, unless specified otherwise:
- Men or women aged 18 years or older at the time of consent.
- Subject has a history of onset of hidradenitis suppurativa for at least 6 months prior to Baseline (Day 0) Visit.
- Subject has hidradenitis suppurativa with at least 5 inflammatory nodules or abscesses (total AN count) in at least 2 distinct anatomic areas, both at Screening and Baseline (Day 0) Visits. Furthermore, one additional inflammatory nodule must be present for collection of skin biopsies.
- Subjects (women and men) involved in any sexual intercourse that could lead to pregnancy must agree to use an effective contraceptive method from at least 4 weeks before Baseline (Day 0) until at least 4 weeks after the last study product administration for the duration of the study. Effective contraceptive methods are: systemic hormonal contraceptives (oral contraceptive, patch, vaginal ring, injectables, or implants), intrauterine devices, vasectomy, or barrier methods of contraception in conjunction with spermicide. Hormonal contraceptives must be on a stable dose for at least 4 weeks before Baseline (Day 0).
- Note: Woman of non-childbearing potential are as follows:
- Women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation).
- Women ≥ 60 years of age.
- Women \> 40 and \< 60 years of age who have had a cessation of menses for at least 12 months and a follicle-stimulating hormone (FSH) test confirming non-childbearing potential (FSH ≥ 40 mIU/mL) or cessation of menses for at least 24 months without FSH levels confirmed.
- Protocol RGRN-305 - Safety and Efficacy of RGRN-305 in HS Page 13 of 61 Protocol version 3.2: 13 September 2021
- Women of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at Baseline (Day 0).
- Subject must have negative tuberculosis (TB) infection tests. Subjects will be evaluated for latent TB infection with a purified protein derivative (PPD) test, T-spot test or a Quantiferon Gold test, and with a chest x-ray, if one has not been performed in the last 6 months. Subject who demonstrates evidence of latent TB infection (either PPD ≥ 5 mm of induration or positive Quantiferon Gold or T-spot test, irrespective of Bacillus Calmette-Guérin (BCG) vaccination status and negative chest x-rays findings for active TB, or suspicious chest x-ray findings) will not be allowed to participate in the study.
- Subject must be willing to participate and must be capable of giving informed consent, and the consent must be obtained prior to any study-related procedures.
Exclusion
- Female subject who is breastfeeding, pregnant, or who is planning a pregnancy during the study.
- Subject has a history of skin disease or presence of a skin condition that, in the opinion of the investigator, would interfere with the study assessments.
- Subject is known to have immune deficiency or is immunocompromised.
- Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Baseline (Day 0). Subjects with successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix are not to be excluded.
- Subject has had a major surgery within 8 weeks prior to Baseline (Day 0) or has a major surgery planned during the study.
- Subject has any clinically significant medical condition including ongoing infections, or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
- Subject has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values ≥ 2 times the upper limit of normal (ULN) at Screening.
- Subject has absolute neutrophil count ≤ 1.5 X 109/L or platelet count ≤ 100 X 109/L at Screening.
- Subject has a history of clinically significant anemia or hemoglobin (Hgb) value ≤ 10 g/dL (6.21 mmol/dL) at Screening.
- Subject has a creatine clearance ≤ 60 mL/min at Screening (calculated with Cockcroft-Gault formula).
- Subject with positive results for hepatitis B surface antigens (HBsAg), anti-hepatitis B core antibodies (anti-HBc), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Subject has a known or suspected allergy to RGRN-305 or any component of the investigational product.
- Subject has a history of clinically significant drug or alcohol abuse in the last year prior to Baseline (Day 0) Visit.
- Subject is currently receiving an investigational product or device or has received one within 4 weeks prior to Baseline (Day 0) Visit.
- Subject has received a live attenuated vaccine within 4 weeks prior to Baseline (Day 0) Visit or plan to receive a live attenuated vaccine during the study and up to 1 month after the last study drug administration.
- Subject has a history of an allergic reaction or significant sensitivity to lidocaine or other local anesthetics.
- Subject has a history of hypertrophic scarring or keloid formation in scars or suture sites.
- Known inability or unavailability of a subject to complete required study visits during study participation.
- A psychiatric condition (e.g., suicidal ideation), chronic alcohol, or drug abuse problem, determined from the subject's medical history, which, in the opinion of the investigator, may pose a threat to subject compliance.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05286567
Start Date
September 1 2021
End Date
August 29 2022
Last Update
January 31 2023
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200