Phase 2, randomized, parallel-group, double-blind, placebo-controlled study of sonelokimab in patients with active moderate to severe hidradenitis suppurativa
- Conditions
- boil-like lumps or abscesses that can occur in the armpitsbuttocks or under the breasts.groinHidradenitis Suppurativa (acne inversa)Its characteristics include recurrentpainful nodulesperianal area10014982
- Registration Number
- NL-OMON51658
- Lead Sponsor
- -
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
1. >=18 years of age.
2. Diagnosed with HS and has a history of signs and symptoms of HS dating back
at least 6 months.
3. Total AN count (i.e., abscesses and/or inflammatory nodules) of >=5.
4. Subject has HS lesions present in >=2 distinct anatomical areas at least one
of which must contain single or multiple fistulas (i.e., be Hurley Stage II or
III);
5. Subject had an inadequate response to appropriate systemic antibiotics for
treatment of HS (or demonstrated intolerance to, or had a contraindication to,
systemic antibiotics for treatment of their HS).
6. Participants must a suitable candidate for treatment with adalimumab per
approved local product information. If a chest X-ray or computed tomography
(CT) for tuberculosis (TB) screening is required per local guidance, the X-ray
or CT must have been taken within 3 months prior to the Screening.
7. If the subject is female, must be of non-childbearing potential or if of
childbearing potential, participant must agree to use highly effective methods
of contraception.
8. Women of childbearing potential must have a negative serum human chorionic
gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy
test at Week 0/Day1 prior to the first administration of study treatment.
9. If male, participant must be willing to use a condom when sexually active
with a partner of childbearing potential during the study and for 12 weeks
after the last dose of study drug, unless surgically sterile.
10. Participant is considered reliable and capable of adhering to the protocol,
visit schedule, or medication intake according to the judgment of the
investigator.
11. Participant is able to understand and provide signed informed consent.
1. Known hypersensitivity to sonelokimab, adalimumab or any of its excipients.
2. Draining fistula count of >=20.
3. Any other active skin disease or condition that may interfere with the
assessment of HS.
4. Subject who currently use or plan used one or more prohibited treatments
specified in this protocol.
5. Subjects enrolling in the non-antibiotic strata: use of systemic antibiotics
for the treatment of HS within 28 days.
6. Previous exposure or subject in a study of brodalumab (anti-IL-17RA) and/or
bimekizumab (anti-IL17 A/F).
7. Unsuitable for interleukin (IL)-17A therapy and anti-tumor necrosis factor
alpha (TNFa) therapy.
8. Prior exposure to more than 2 biologic response modifiers.
9. Diagnosis of ulcerative colitis or Crohn's disease.
10. Subject has an active infection or history of infections.
11. Participant with evidence of tuberculosis infection (TB) at screening
unless the following criteria apply:
i. A full TB work-up within 12 weeks establishes no evidence of active TB
infection.
ii. Positive for latent TB per work-up must have completed sufficient treatment
at least 4 weeks prior.
12. Any current nontuberculous mycobacterial (NTM) infection or any history of
pulmonary NTM infection.
13. Concurrent acute or chronic viral hepatitis B virus (HBV) or hepatitis C
virus (HCV) infection.
14. Evidence of human immunodeficiency virus (HIV) infection.
15. Tests positive for Severe Acute Respiratory Syndrome Coronavirus 2
(SARS-CoV-2) infection.
16. Concurrent malignancy or a history of malignancy during the past 5 years of
with the following exceptions:
a. <=3 successfully excised or ablated, basal cell carcinomas of the skin.
b. One squamous cell carcinoma of the skin not worse than Stage T1 that has
been successfully treated, with no signs of recurrence or metastases for at
least the past 2 years.
c. Actinic keratosis.
d. Squamous cell carcinoma in situ of the skin successfully treated >6 months.
e. Localized carcinoma in situ of the cervix treated and considered cured.
17. History of a lymphoproliferative disorder including lymphoma or current
signs and symptoms suggestive of lymphoproliferative disease.
18. Primary immunodeficiencies, prior splenectomy, or suppressive conditions,
including subjects taking immunosuppressive therapy following organ transplants.
19. Had major surgery (e.g., hip replacement, aneurysm removal) within 6 months
or is planning to have major surgery during the study.
20. History or concurrent clinically significant medical conditions or any
other reason, including any physical, psychological, or psychiatric condition,
that would compromise the safety or interfere with the subject's participation
in the study, would make the participant an unsuitable candidate to receive
study drug, or would put the participant at risk.
21. Has received live (including attenuated) vaccination within 8 weeks or
planned during the study and up to at least 12 weeks after the last dose of
study drug.
22. Has received Bacillus Calmette-Guérin vaccination within 1 year.
23. Presence of active suicidal ideation, or positive suicidal behavior; any
history of suicidal attempt (including an actual attempt, interrupted attempt,
or aborted attempt), or suicidal ideation in the past 6 months.
24. Presence of moderately severe depression or
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Percentage of participants achieving Hidradenitis Suppurativa Clinical<br /><br>Response (HiSCR) 75 at Week 12, where HiSCR75 is defined as at<br /><br>least a 75% reduction from baseline in abscess and inflammatory nodule (AN)<br /><br>count, with no increase from baseline in abscess or draining fistula<br /><br>count.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Proportion of participants achieving HiSCR50 at Week 12.<br /><br>2. Change from baseline in International Hidradenitis Suppurativa Severity<br /><br>Score System (IHS4) at Week 12;<br /><br>3. Proportion of participants achieving a Dermatology Life Quality Index (DLQI)<br /><br>total score of <=5 at Week 12.<br /><br>4. Proportion of participants achieving at least 30% reduction and at least<br /><br>1-unit reduction from baseline in Numerical Rating Scale (NRS) 30<br /><br>in Patient's Global Assessment of Skin Pain (PGA) of Skin Pain at Week 12 among<br /><br>subjects with baseline NRS >=3.</p><br>