| Eligibility |
Inclusion Criteria:
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:
1. Men or women aged 18 years or older at the time of consent.
2. Subject has a history of onset of hidradenitis suppurativa for at least 6 months prior
to Baseline (Day 0) Visit.
3. 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.
4. 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
5. Women of childbearing potential must have a negative serum pregnancy test at screening
and negative urine pregnancy test at Baseline (Day 0).
6. 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.
7. 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 Criteria:
1. Female subject who is breastfeeding, pregnant, or who is planning a pregnancy during
the study.
2. 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.
3. Subject is known to have immune deficiency or is immunocompromised.
4. 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.
5. Subject has had a major surgery within 8 weeks prior to Baseline (Day 0) or has a
major surgery planned during the study.
6. 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.
7. Subject has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values
= 2 times the upper limit of normal (ULN) at Screening.
8. Subject has absolute neutrophil count = 1.5 X 109/L or platelet count = 100 X 109/L at
Screening.
9. Subject has a history of clinically significant anemia or hemoglobin (Hgb) value = 10
g/dL (6.21 mmol/dL) at Screening.
10. Subject has a creatine clearance = 60 mL/min at Screening (calculated with
Cockcroft-Gault formula).
11. 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).
12. Subject has a known or suspected allergy to RGRN-305 or any component of the
investigational product.
13. Subject has a history of clinically significant drug or alcohol abuse in the last year
prior to Baseline (Day 0) Visit.
14. Subject is currently receiving an investigational product or device or has received
one within 4 weeks prior to Baseline (Day 0) Visit.
15. 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.
16. Subject has a history of an allergic reaction or significant sensitivity to lidocaine
or other local anesthetics.
17. Subject has a history of hypertrophic scarring or keloid formation in scars or suture
sites.
18. Known inability or unavailability of a subject to complete required study visits
during study participation.
19. 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.
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