| Eligibility |
Inclusion Criteria:
Written informed consent provided by the patient. Male or female, age 18 years. BMI of 27
or greater Subject must be in general good health (except for hidradenitis suppurativa) as
judged by the investigator, based on medical history, physical examination, clinical
laboratories, and urinalysis. NOTE: the definition of good health means a subject that does
not have uncontrolled significant co-morbid conditions.
Must have a diagnosis of HS for at least 6 months prior to Baseline/Screening visit
Subjects with moderate to severe HS with a PGA score of 3 or more. 3 is defined as having:
0 abscesses, 0 draining fistula, and 5 inflammatory nodules; or 1 abscess or draining
fistula and 1 inflammatory nodule; or 2-5 abscesses or draining fistulas and 10
inflammatory nodules. Patients with more than 5 abscesses or 5 draining fistulas, and/or
excessive scarring, will be excluded.
HS lesions must be present in at least two distinct anatomic areas, one of which must be at
least Hurley Stage II (see definition of terms) Subject must have stable HS for at least 2
months (60 days) prior to Screening/Baseline visit as determined by the investigator
through subject interview and review of medical history.
Subject must agree to daily use (and throughout the entirety of the study) of one of the
following over-the- counter topical antiseptics on their HS lesions: chlorhexidine
gluconate, triclosan, benzoyl peroxide, or dilute bleach in bathwater.
Premenopausal women must have a negative serum pregnancy test on entry in the study.
Women who are post-menopausal will have their FSH checked to confirm their status.
Females of childbearing potential (FCBP)† must have a negative pregnancy test at Screening
and Baseline. While on investigational product and for at least 28 days after taking the
last dose of investigational product, FCBP who engage in activity in which conception is
possible must use one of the approved contraceptive options described below:
Option 1: Any one of the following highly effective methods: hormonal contraception
(injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal
ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or
nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane];
PLUS, one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with
spermicide; or (c) contraceptive sponge with spermicide d) oral hormonal contraception.
Use of Tirzepatide may reduce the efficacy of oral hormonal contraceptives due to delayed
gastric emptying. This delay is largest after the first dose and diminishes over time.
Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive
method, or add a barrier method of contraception for 4 weeks after initiation and for 4
weeks after each dose Escalation with tirzepatide.
Male subjects (including those who have had a vasectomy) who engage in activity in which
conception is possible must use barrier contraception (male latex condom or nonlatex condom
NOT made from natural [animal] membrane [for example, polyurethane]) while on
investigational product and for at least 28 days after the last dose of investigational
product.
A female of childbearing potential is a sexually mature female who 1) has not undergone a
hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical
removal of both ovaries) and 2) has not been postmenopausal for at least 24 consecutive
months (that is, has had menses at any time during the preceding 24 consecutive months).
The female subject's chosen form of contraception must be effective by the time the female
subject is screened into the study (for example, hormonal contraception should be initiated
at least 28 days before screening).
The screening/baseline laboratory test results must meet the following criteria (WNL means
within normal limits for patients with HS [e.g., may have slightly higher WBC and platelet
counts]):
- WBC (white blood cell count): WNL
- ANC (absolute neutrophil count): WNL
- Hemoglobin: >10 mg/dl
- Platelets: WNL
- Serum Creatinine: WNL
- SGOT (AST - aspartate aminotransferase): <3 times upper normal limit
- SGPT (ALT - alanine aminotransferase): <3 times upper normal limit
- Alkaline phosphatase:<3 times upper normal limit
- FSH for postmenopausal women (to confirm menopause has occurred and exclude the need
for contraception)
Exclusion Criteria:
Subjects with 20 nodular lesions and/or significant scarring (defined as any linear,
indurated area, extended across more than 50% of the circumference of the affected area),
more than 5 abscesses, more than 5 fistulas or sinus tracts.
Patient with PGA 0-2 (no disease or minimal disease i.e.: Hurley Stage 1) will be excluded.
Patients with BMI lower than 27 Patients with a personal or family history of MTC or in
patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Patients with Type 1 Diabetes Mellitus History of pancreatitis Other than hidradenitis
suppurativa, any clinically significant (as determined by the investigator) cardiac,
endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic,
immunologic disease, or other major disease that is currently uncontrolled.
Any condition, including the presence of laboratory abnormalities, which would place the
subject at unacceptable risk if he/she were to participate in the study. Prior history of
suicide attempt at any time in the subject's lifetime prior to or major psychiatric illness
requiring hospitalization within the last 3 years.
Women who are pregnant, nursing, or planning pregnancy within 6 months after the last study
drug dose (this includes fathers who plan on fathering a child within 6 months after their
last study drug dose.
Known serious hypersensitivity to tirzepatide or any of the excipients in it. Serious
hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with
tirzepatide.
Active substance abuse or a history of substance abuse within 6 months prior to Screening
Malignancy or history of malignancy, except for treated [i.e., cured] basal cell or
squamous cell in situ skin carcinomas; treated [i.e., cured] cervical intraepithelial
neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the
previous 5 years.
Active substance abuse or a history of substance abuse within 6 months prior to screening
Patient with diagnosis or suspected Crohn's disease or ulcerative colitis. Patient who is
on a stable dose of analgesics, will be allowed to remain on them. No new opiates will be
permitted during the trial.
Use of any investigational drug within 5 weeks prior to screening, or 5
pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
Known allergy to tirzepatide, semaglutide, exenatide, liraglutide or other incretins (GLP1
receptor agonists) Have a known history of serious infections (i.e, hepatitis, pneumonia or
pyelonephritis) in the previous 3 months Have a history of lymphoproliferative disease,
including lymphoma or signs suggestive of possible lymphoproliferative disease such as
lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the
neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly Have current
signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic,
gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or
lack of easy access.
Patient with significant scarring, fistulas, or sinus tract involvement will be excluded.
Only subjects with inflammatory abscesses and nodules will be allowed to enter the study.
Infection(s) requiring treatment with intravenous (IV) anti-infectives (antibiotics,
antivirals, antifungals) within 30 days prior to Baseline or oral anti-infectives
(antibiotics, antivirals, antifungals) within 14 days prior to Baseline.
Any other active skin disease or condition (e.g., bacterial, fungal or viral infection)
that may interfere with assessment of HS; History of invasive infection (e.g., listeriosis,
histoplasmosis), human immunodeficiency virus (HIV); Subject has an active systemic viral
infection or any active viral infection that based on the investigator's clinical
assessment make the subject an unsuitable candidate for the study; Hepatitis B: HBsAg
positive (+) or detected sensitivity on the HBV-DNA PCR qualitative test for HBc Ab/HBsAb
positive subjects; Or Hepatitis C Have evidence of active or Latent TB Pregnant (or
considering becoming pregnant) or lactating females. Subjects currently undergoing any of
the following treatments for HS will require a 4 week wash- out period: minocycline;
tetracycline; clindamycin; rifampin and steroids. Patients treated with any biologic
therapy including adalimumab, will require a washout period of 5 half lives.
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