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New treatment option for Nonsegmental Vitiligo
Official title A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
ClinicalTrials.gov ID: NCT07108283
What this study is testing
What is Zasocitinib?
Zasocitinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nonsegmental vitiligo.
Also referred to as TAK-279.
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
- Vitiligo is a long-term autoimmune condition that causes the skin to lose its color. The body's germ-fighting system (immune system) mistakenly attacks the skin cells (melanocytes) which produce the pigment that gives the skin color (melanin).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
- 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 to 75
You may be able to join if
- Participant willingness:
- Participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in...
- Participant has provided written informed consent and any required privacy authorization before the initiation of any trial procedures. Disease...
- Participants must have a clinical diagnosis of nonsegmental vitiligo: F-VASI greater than or equal to (\>=) 0.5 and a T-VASI \>= 5 and less than or...
- Participant is aged \>=18 years to \<=75 years old at the time of consent.
You likely can't join if
- Target Disease-Related Exclusions:
- Participant has segmental vitiligo (including mixed vitiligo) or any other congenital or acquired cause of hypopigmentation or depigmentation that...
- Participant has \>50 percent (%) leukotrichia on the face or \>50% leukotrichia of the body (includes the face), within the skin affected by vitiligo.
- Participant requires immunomodulatory or immunosuppressive systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial...
- Participant has a history of phototherapy (including, but not limited to, broadband Ultra-Violet [UV]-B, narrowband UV-B, psoralen and UV-A, excimer...
- Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
See the full eligibility criteria
Who can join
- Participant willingness:
- Participant is willing and able to understand and fully comply with trial procedures and requirements (including 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 a clinical diagnosis of nonsegmental vitiligo: F-VASI greater than or equal to (\>=) 0.5 and a T-VASI \>= 5 and less than or equal to (\<=) 50 at screening and Day 1. Age and Reproductive Status:
- Participant is aged \>=18 years to \<=75 years old at the time of consent.
- Participant meets the following birth control requirement: An individual with potential for pregnancy who is now of nonchildbearing potential with laboratory confirmation of postmenopausal status; or an individual with...
- For participants in the EU/EEA or UK, 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...
What rules you out
- Target Disease-Related Exclusions:
- Participant has segmental vitiligo (including mixed vitiligo) or any other congenital or acquired cause of hypopigmentation or depigmentation that could interfere with the diagnosis or assessment of nonsegmental...
- Participant has \>50 percent (%) leukotrichia on the face or \>50% leukotrichia of the body (includes the face), within the skin affected by vitiligo.
- Participant requires immunomodulatory or immunosuppressive systemic treatment, other than nonsteroidal anti-inflammatory drugs, during the trial period for an immune-related disease (for example, inflammatory bowel...
- Participant has a history of phototherapy (including, but not limited to, broadband Ultra-Violet [UV]-B, narrowband UV-B, psoralen and UV-A, excimer or other laser therapy, or tanning booth use) within 8 weeks before...
- Participant has concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
- History of any depigmenting or bleaching treatment for vitiligo or other skin disorder (for example, monobenzone or phenol).
- History of any surgical treatments for vitiligo.
- History of recent or progressive undiagnosed hearing loss. Recent/Concurrent Infectious Disease Exclusions:
- Tuberculosis (TB):
- Participant has history of active TB infection, regardless of treatment status.
- Participant has 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.
- Participant has 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 (CT), 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...
- Non-herpetic viral diseases:
- Participant has presence of Hepatitis C Virus (HCV) antibody and a positive confirmatory test result for HCV Ribonucleic Acid (RNA) (nucleic acid test or polymerase chain reaction). In the EU/EEA and the UK, if the...
- Participant has presence of positive Hepatitis B surface antigen (HBsAg), or indeterminate HBsAg, presence of Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) (regardless of serology), or positive anti- Hepatitis B...
- Participant has positive results for Human Immunodeficiency Virus (HIV) by serology, regardless of viral load.
- Other infectious diseases:
- Participant has a history of active infection or febrile illness (with or without other symptoms) within 7 days prior to Day 1, as assessed by the investigator.
- Participant has a history of serious or severe infection within 30 days prior to Day 1, as assessed by the investigator.
- Participant has a history of bacterial, viral, or fungal infection that required hospitalization or treatment with intravenous antimicrobial therapy within 8 weeks prior to Day 1, or oral antimicrobial therapy within 30...
- 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/infections...
- 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, 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 thyroid disease, lupus, sjogrens, 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 cancer or lymphoproliferative disease with the exception of successfully treated nonmetastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the...
- For participants with asthma, chronic obstructive pulmonary disease, or other pulmonary illnesses has ever required intubation for treatment, currently requires oral corticosteroids, or has required more than 1 course...
- 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, non-acute 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 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 any lifetime history of suicide attempts, suicidal behavior, or active suicidal ideation with intent and plan based on medical history or a YES response to Columbia-Suicide Severity Rating Scale (C-SSRS)...
- Participant has a history of clinically significant drug or alcohol abuse within 12 months prior to Day 1. Laboratory/Physical Exclusions:
- Participant has any of the following laboratory values at the screening visit:
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) values \>=3 times the Upper Limit of Normal (ULN).
- Total bilirubin (unconjugated and/or conjugated) ˃1.5 times the ULN.
- Hemoglobin (Hgb) \<9.0 gram/deciliter (g/dL) (\<90.0 gram/Liter [g/L]).
- Absolute white blood cell count less than (\<) 3.0 \ 10\^9/Liter (L) (\<3000/cubic millimeter [mm\^3]).
- Absolute neutrophil count 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) outside the normal reference range AND free T4 or T3 outside the normal reference range.
- Estimated creatinine clearance \<45 milliliter/minute (mL/min) based on the Cockcroft-Gault calculation.
- Creatine Phosphokinase (CPK) \> ULN. CPK may be repeated once; if repeat value is Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or lower (or \<=2.5 × ULN) and no higher than the initial value...
- 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 undergo in vitro fertilization, donate ova (eggs), or sperm, or participant is lactating/nursing.
- Participant has given greater than 500 mL of blood or plasma within 30 days of screening (during a clinical trial or at a blood bank donation) or plans 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...
- History of rhabdomyolysis.
The study team makes the final eligibility decision.
Where it's taking place
- Bryant, Arkansas, United States
- Fountain Valley, California, United States
- Fremont, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Boynton Beach, Florida, United States
- Miami Lakes, Florida, United States
- Tampa, Florida, United States
- Weston, Florida, United States
- Baton Rouge, Louisiana, United States
- New Orleans, Louisiana, United States
- Rockville, Maryland, United States
- Canton, Michigan, United States
- New York, New York, United States
- Bexley, Ohio, United States
- Charleston, South Carolina, United States
- Bellaire, Texas, United States
- Plano, Texas, United States
- San Antonio, Texas, United States
+ 45 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 1 year 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bryant, Arkansas, United States; Fountain Valley, California, United States; Fremont, California, United States; Los Angeles, California, United States; Sacramento, California, United States; San Diego, California, United States and 59 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.