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New treatment option for Hidradenitis Suppurativa
Official title A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT07244263
What this study is testing
What is Zasocitinib (Dose A)?
Zasocitinib (Dose A) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hidradenitis suppurativa.
Also referred to as TAK-279, NDI-034858.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant Willingness:
- Participant is willing and able to understand and fully comply with all trial procedures and requirements (including the use of digital tools and...
- Participant has provided written informed consent and any required privacy authorization before the initiation of any trial procedures. Disease...
- Participants must have signs and symptoms of hidradenitis suppurativa (HS) for at least 6 months prior to screening, and a diagnosis of HS (confirmed...
- 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...
You likely can't join if
- Target Disease-Related Exclusions:
- 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...
- 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...
- Tuberculosis (TB):
See the full eligibility criteria
Who can join
- Participant Willingness:
- 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. Disease Characteristics:
- 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...
- 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.
- Participants must have a total of greater than or equal to (\>=) 5 inflammatory lesions (that is, number of abscesses plus number of inflammatory nodules) at both screening and Day 1.
- Participants must have a history of inadequate response to a previous course of oral antibiotic for treatment of HS or exhibited recurrence, intolerance, or contraindication during that course of oral antibiotic, as...
- Participant is aged \>=18 years at the time of consent. In the European Union (EU)/European Economic Area (EEA), for participants aged 65 years or older, the investigator must document a favorable benefit-risk...
- Participant meets the following birth control requirement:
- An individual with potential for pregnancy, who is now surgically sterile; OR
- An individual of nonchildbearing potential with laboratory confirmation of postmenopausal status; OR
- If sexually active with a nonsterilized individual who produces sperm, an individual with potential for pregnancy who agrees to use a highly effective method of contraception from the signing of informed consent...
- For participants in the EU/EEA, the investigator must have no reason to believe that the participant would be placed at risk by participating in the trial with regard to the European Commission decision as of 10 March...
What rules you out
- Target Disease-Related Exclusions:
- 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...
- 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. Recent/Concurrent Infectious Disease Exclusions:
- Tuberculosis (TB):
- Participants have a history of active TB infection, regardless of treatment status.
- Participants have signs or symptoms of active TB (including, but not limited to, chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator.
- Participants have evidence of latent tuberculosis infection (LTBI) as evidenced by a positive QuantiFERON (QFT) result OR 2 indeterminate QFT results, and participant does not have documentation of appropriate LTBI...
- Participant has had any imaging trial during or 6 months prior to screening, including x-ray, chest computed tomography, magnetic resonance imaging, or other chest imaging suggesting evidence of current active or a...
- Herpes infections:
- Participant has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or Day 1.
- Participant has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2...
- Nonherpetic viral diseases:
- Participant has presence of hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV RNA (nucleic acid test or polymerase chain reaction [PCR]). In the EU/EEA, if the participant has total...
- Participant has presence of positive hepatitis B virus surface antigen (HBsAg), or indeterminate HBsAg, presence of HBV DNA (regardless of serology), or positive anti-hepatitis B core antibody (HBcAb) without concurrent...
- Participant has positive results for HIV by serology, regardless of viral load.
- Other infectious diseases:
- Participant has a history of active infection or febrile illness within 10 days prior to Day 1, as assessed by the investigator.
- Participant has a history of symptoms suggestive of systemic or invasive infection within 30 days prior to Day 1.
- Participant has a history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous (IV) antimicrobial therapy within 8 weeks prior to Day 1, or oral antimicrobial therapy...
- Participant has a history of chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations (except...
- Participant has a history of an infected joint prosthesis unless that prosthesis has been removed or replaced at least 60 days prior to Day 1.
- Participant has a history of opportunistic infections (for example, Pneumocystis jirovecii pneumonia, histoplasmosis, or coccidiomycosis).
- Participant had a bacterial infection within 60 days prior to Day 1 for which he or she did not receive treatment. Noninfectious Disorders Exclusions:
- Participant has any clinically significant medical condition, evidence of an unstable clinical condition (for example, cardiovascular, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, neurologic...
- Participant has a history of known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency, splenectomy.
- Participant has a history of new or unstable autoimmune disease (including but not limited to autoimmune thyroid disease, alopecia areata, lupus, Sjogren's, myasthenia gravis, or rheumatoid arthritis).
- Participant had a major surgery within 60 days prior to Day 1 or has a major surgery planned during the trial.
- Participant has unstable, poorly controlled, or severe hypertension at screening, confirmed by 2 repeat assessments.
- Participant has a history of Class III or IV congestive heart failure as defined by New York Heart Association criteria.
- Participant has a history of lymphoproliferative disease.
- For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses, participant has been hospitalized in the past 3 months, has ever required intubation for treatment, currently requires...
- Participant has any of the following cardiovascular disease history:
- A new diagnosis of atrial fibrillation or an episode of atrial fibrillation with rapid ventricular response or other dysrhythmia, nonacute cardiac hospitalization (for example, pacemaker implantation), pulmonary...
- Any history of cerebrovascular event, myocardial infarction, coronary stenting, or aortocoronary bypass surgery. If, however, the investigator documents there are no suitable treatment alternatives available for the...
- Participant has significant/uncontrolled psychiatric illness, in the opinion of the investigator.
- Participant has any lifetime history of suicide attempts, or active suicidal ideation or suicidal behavior in the past 5 years, or any diagnosis of severe depression or other unstable psychiatric condition in the last 6...
- Participant has a score of 15 or above at screening or Day 1 on the 8-item Patient Health Questionnaire-8 (PHQ-8).
- Participant has a history of active substance abuse or a history of substance abuse within 12 months prior to screening. Laboratory/Physical Exclusions:
- Participant has ECG abnormalities that are considered clinically significant and would pose an unacceptable risk to the participant if they participated in the trial, in the opinion of the investigator.
- Participant has inadequate renal, hepatic, or pancreatic function before enrollment based on the following parameters:
- Total bilirubin (unconjugated and/or conjugated) \>1.5 × upper limit of the normal range (ULN) unless the participant has known Gilbert's syndrome that can explain the elevation of bilirubin, or
- Serum alanine aminotransferase (ALT) or AST \>3 × ULN, or
- Creatinine \>1.5 × ULN. Note: The participant may be retested (1 time) to meet eligibility criteria at the discretion of the investigator.
- Estimated creatinine clearance lesser than (\<)45 milliliter per minute (mL/min) based on the Cockcroft-Gault calculation.
- A history of chronic pancreatitis or recent acute pancreatitis (\<60 days/not fully resolved).
- Participant has any of the following laboratory values at the screening visit:
- Hemoglobin \<9.0 gram per deciliter (g/dL) (\<90.0 gram per liter [g/L]).
- Absolute white blood cell count \<3.0 × 10\^9/L (\<3000/ cubic millimeters [mm\^3]).
- Absolute neutrophil count (ANC) of \<1.0 × 10\^9/L (\<1000/mm\^3).
- Absolute lymphocyte count of \<0.5 × 10\^9/L (\<500/mm\^3).
- Platelet count \<100 × 10\^9/L (\<100,000/mm\^3).
- Thyroid-stimulating hormone (TSH) (\>10 milli-international units per liter [mIU/L]) or free T4 or T3 outside the normal reference range. Note: Participants would be allowed to rescreen after treatment.
- Triglyceride level \>=750 milligram per deciliter [mg/dL] (\>=8.5 millimole per liter [mmol/L]).
- Creatine phosphokinase (CPK) \> ULN. CPK may be repeated once; if repeat value is Common Terminology Criteria for Adverse Events (National Cancer Institute) (CTCAE) Grade 1 or lower (or lesser than or equal to [\<=]2.5...
- Participant has any other significant laboratory abnormalities that, in the opinion of the investigator, might place the participant at unacceptable risk for participation in this trial.
- Participant does not tolerate venipuncture or inability to be venipunctured. Allergies and Adverse Drug Reactions Exclusions:
- Participant has a history of significant drug allergy (such as anaphylaxis).
- Participant has a known or suspected allergy to zasocitinib or any of its components. Other Exclusions:
- Participant has a positive pregnancy test result or plans to become pregnant during the trial period, including plans to donate ova (eggs) or sperm, or participant is pregnant or lactating/nursing.
- Participant has a history of substance abuse within 12 months prior to Day 1.
- Participants who have given greater than 500 mL of blood or plasma within 30 days prior to screening (during a clinical trial or at a blood bank donation) or plan to donate blood during the course of the trial.
- Participant is compulsorily detained for treatment of either a psychiatric or physical (for example, infectious disease) illness, or is committed to an institution (for example, prison) by virtue of an order issued...
- Participant is a trial site employee, an immediate family member (for example, spouse, parent, child, sibling), or is in a dependent relationship with trial site employee who is involved in the conduct of this trial or...
- In Germany, participant is incapable of giving consent or otherwise meets criteria in Sections 136 or 137 of the Verordnung zum Schutz vor der schädlichen Wirkung ionisierender Strahlung Strahlenschutzverordnung.
- Participants with a history of malignancy within the past 5 years prior to the screening visit are excluded, EXCEPT if the malignancy was a cutaneous squamous or basal cell carcinoma, or in situ cervical cancer that has...
- History or current status of substance use disorder and or tobacco use disorder. For participants with excessive alcohol intake or currently smoking or using chewing tobacco or with a history of long-term smoking (\>=20...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Fort Smith, Arkansas, United States
- Fountain Valley, California, United States
- Hialeah, Florida, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Fort Gratiot, Michigan, United States
- Greenland, New Hampshire, United States
- Lake Success, New York, United States
- New York, New York, United States
- Mayfield Heights, Ohio, United States
- Portland, Oregon, United States
- Arlington, Texas, United States
- Dallas, Texas, United States
- Darlinghurst, New South Wales, Australia
- Westmead, New South Wales, Australia
- Carlton, Victoria, Australia
- Melbourne, Victoria, Australia
- Calgary, Alberta, Canada
+ 28 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Fort Smith, Arkansas, United States; Fountain Valley, California, United States; Hialeah, Florida, United States; Tampa, Florida, United States; Boston, Massachusetts, United States and 42 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.