A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
ConditionHidradenitis Suppurativa
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
Hidradenitis Suppurativa (HS) is a skin condition that causes deep, painful bumps on the skin. These bumps usually appear in an area where the skin rubs together. They start as small bumps but may become swollen and red over time. If they fill with pus, these lumps are called abscesses; these can also burst. Over time, the area can get scars and tunnels on or under the skin. Recent studies suggest that the condition may start when hair follicles become damaged and blocked. This impacts the skin and may activate the body's germ-fighting (immune) system. This allows bacteria to grow on the skin which worsens the condition and can cause abscesses.
The main aims of this study are to learn how safe zasocitinib is, how well it works and how well adults with HS tolerate it compared with a placebo.
The participants will receive the study treatment (either zasocitinib or placebo) for up to 4 months (16 weeks). The placebo looks like the zasocitinib capsule but does not have any medicine in it. After the first 4 months, all participants (also those who initially received placebo) will then receive zasocitinib for up to 8 months (36 weeks).
During the study, participants will visit their study clinic 12 times.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is willing and able to understand and fully comply with all trial procedures and requirements (including the use of digital tools and applications), in the opinion of the investigator.
Participant has provided written informed consent and any required privacy authorization before the initiation of any trial procedures.
Participants must have signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior to screening, and a diagnosis of HS (confirmed by a dermatologist) at the screening visit with stable HS signs and symptoms for 2 months before screening, as determined by the investigator through interview or medical history.
Participants should have HS lesions in at least 2 distinct anatomical areas, one of which must be at least Hurley Stage II or III at both screening and Day 1.
Disqualifiers
Participant has a draining tunnel count of greater than (>) 20 at screening or Day 1.
Participant has any other active skin disease or condition (for example, bacterial cellulitis, Candida intertrigo, extensive condyloma) that may, in the opinion of the investigator, interfere with the assessment of HS or participant has developed a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
Participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease.
Participant has a diagnosis of inflammatory conditions other than HS, including but not limited to, psoriasis, psoriatic arthritis, and rheumatoid arthritis.
Trial design
Design model
Parallel
Treatments tested in this trial
Zasocitinib (Dose A)
DrugZasocitinib.
Placebo
Other interventionPlacebo.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Double-blinded: Zasocitinib (Dose A)Experimental treatment 1 intervention
Group B: Double-blinded: PlaceboPlacebo comparator 1 intervention
Group C: Open-label: Zasocitinib (Dose A)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants who Achieve 75 Percent (%) Reduction in Hidradenitis Suppurativa Clinical Response (HiSCR75)
HiSCR75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline.
Time frame
At Week 16Secondary outcomes
1
Percentage of Participants who Achieve 50% Reduction in HiSCR50
HiSCR50 is defined as at least a 50% reduction in the total AN count with no increase in abscess or draining tunnel count relative to baseline.
Time frame
At Week 162
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the trial intervention.
Time frame
From start of study drug up to Week 56 Source ClinicalTrials.gov