DISCLAIMER: This site is for informational purposes only. While we make every effort to keep it up to date, there is no guarantee that information is complete, accurate, comprehensive, or the same for all KP regions. The information on this site should not be interpreted or used as a substitute for professional medical care. Please consult your care provider for any personal health questions or before participating in clinical trials.

Active, not yet recruiting

A Phase 3 Randomized, Double-blind, 52-week Placebo-controlled Multi-center Study With a Double-blind 52-week Extension Period With Randomized Dose up/Dose Down Titration Investigating the Efficacy, Safety, and Tolerability of Ritlecitinib in Adult Participants With Nonsegmental Vitiligo

NCT No.: NCT06072183

Study Type: INTERVENTIONAL

Phase: Phase III

Region: California - Northern

Acronym: 

Official Title

A Phase 3 Randomized, Double-blind, 52-week Placebo-controlled Multi-center Study With a Double-blind 52-week Extension Period With Randomized Dose up/Dose Down Titration Investigating the Efficacy, Safety, and Tolerability of Ritlecitinib in Adult Participants With Nonsegmental Vitiligo

Purpose

The purpose of this study is to learn about the safety and effects of the study medicine ritlecitinib for the possible treatment of nonsegmental vitiligo. Vitiligo causes white patches on your skin when the cells that give your skin color are destroyed. Nonsegmental means that it can affect both sides of the body such as both knees and both hands.

Detailed Description

Additional Principal Investigator for this trial: Paradi Mirmirani

Sex

Male & Female

Age Limit

Eligibility Criteria

Inclusion Criteria

1. Participants aged 18 years (or the minimum age of consent in accordance with local regulations) or older (no upper age limit) at Screening.

  • Meeting reproductive criteria for female participants.

Disease Characteristics:

2. Eligible participants must have at both Screening and BL:

  • A clinical diagnosis of nonsegmental vitiligo for at least 3 months;
   and

  • BSA involvement 4% to 60% inclusive, excluding involvements at
   palms of the hands, soles of the feet, or dorsal aspect of the feet
   and

  • BSA ≥0.5% involvement on the face. Face is defined as including
   the area on the forehead to the original hairline, on the cheek to
   the jawline vertically to the jawline and laterally from the corner of
   the mouth to the tragus. Face will not include scalp, ears, neck, or
   surface area of the lips, but will include the nose and the eyelids;
   and
  
  • F-VASI ≥0.5 and T-VASI ≥3; and

  • Either active or stable nonsegmental vitiligo at Screening and BL
   visits. All participants who do not have the features of active
   vitiligo (defined below) will be classified as having stable disease.
  
Active vitiligo is defined as:

Participants will be classified as having active vitiligo based on the presence of at least one active lesion at BL defined as one of the following:

  • New/extending lesions(s) in the 3 months prior to Screening visit
   (confirmed by photographs or medical record);

  • Confetti-like lesion(s); Confetti-like depigmentation is   
   characterized by the presence of numerous 1-mm to 5-mm
   depigmented macules in clusters;

  • Trichrome lesion(s); Trichrome lesions have a hypopigmented
   zone of varying width between normal and completely
   depigmented skin, resulting in 3 different hues of skin;

  • Koebner phenomenon/phenomena (excluding Type 1 [history
   based on isomorphic reaction]). The Koebner phenomenon
   manifests as depigmentation at sites of trauma, usually in a linear
   arrangement.

Stable vitiligo is defined as:

• Participants will be classified as having stable vitiligo based on an absence of signs of active disease. All participants who do not have the features of active vitiligo (defined above) will be classified as having stable disease.

Eligibility is determined at Screening and Baseline based on the resulting scores from the local in-person reads of F-VASI, T-VASI, and BSA.

3. Additional inclusion criteria are:

  • If receiving concomitant medications for any reason other than
   vitiligo, participant must be on a stable regimen, which is defined
   as not starting a new drug or changing dosage within 7 days or 5
   half-lives (whichever is longer) prior to Day 1. Participant must be
   willing to stay on a stable regimen during the duration of the
   study.

  • Must agree to stop all other treatments for vitiligo from Screening
   through the final follow-up visit.

Exclusion Criteria

Medical Conditions:

1. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

• Any psychiatric condition including recent or active suicidal ideation or behavior that meets defined criteria.

2. Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin:

  • Participants that have other types of vitiligo that do not meet
   criteria for active or stable vitiligo as noted in inclusion criteria
   (including but not limited to segmental vitiligo and mixed vitiligo).

  • Currently have active forms of other hypopigmentation (including
   but not limited to Vogt-Koyanagi-Harada disease, malignancy-
   induced hypopigmentation [melanoma and mycosis fungoides],
   post-inflammatory hypopigmentation, pityriasis alba [minor
   manifestation of atopic dermatitis], senile leukoderma [age-r
   elated depigmentation], chemical/drug-induced leukoderma,
   ataxia telangiectasia, tuberous sclerosis, melasma, and
   congenital hypopigmentation disorder including piebaldism,
   Waardenburg syndrome, hypomelanosis of Ito, incontinentia
   pigmenti, dyschromatosis symmetrica hereditarian, xeroderma
   pigmentosum, and nevus depigmentosus). NOTE: Coexistence of
   halo nevus/nevi (also known as Sutton nevus/nevi) is permitted.

  • Currently have active forms of inflammatory skin disease(s) or
   evidence of skin conditions (for example, but not limited to
   morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic
   dermatitis) at the time of the Screening or BL Visit that in the
   opinion of the investigator would interfere with evaluation of
   vitiligo or response to treatment.

  • Leukotrichia in more than 33% of the face surface area affected
   with vitiligo lesions or leukotrichia in more than 33% of the total
   body surface area affected with vitiligo lesions.

  • Have a superficial skin infection within 2 weeks prior to first dose
   on Day 1. NOTE: participants may be rescreened after the
   infection resolves.

3. General Infection History:

  • Have a history of systemic infection requiring hospitalization,
   parenteral antimicrobial, antiviral (including biologic treatment),
   antiparasitic, antiprotozoal, or antifungal therapy, or as otherwise
   judged clinically significant by the investigator within 6 months
   prior to Day 1.

  • Have active acute or chronic infection requiring treatment with
   oral antibiotics, antivirals, antiparasitics, antiprotozoals, or
   antifungals within 4 weeks prior to Day 1. NOTE: participants may
   be rescreened after the infection resolves.

  • Evidence or history of untreated, currently treated or inadequately
   treated active or latent infection with Mycobacterium tuberculosis.

4. Specific Viral Infection History:

  • History (single episode) of disseminated HZ or disseminated
   herpes simplex or recurrent (more than one episode of) localized,
   dermatomal HZ.

  • Infected with HBV or HCV: all participants will undergo screening
   for HBV and HBC for eligibility.

  • Participants who are positive for HCVAb and HCV RNA will not
   be eligible for this study.

  • Have a known immunodeficiency disorder (including positive
   serology for HIV at screening) or a first-degree relative with a
   hereditary immunodeficiency.

5. Other Medical Conditions:

  • Current or recent history of clinically significant severe,
   progressive, or uncontrolled renal (including but not limited to
   active renal disease or recent kidney stones), hepatic,
   hematological, gastrointestinal, metabolic, endocrine (eg,
   untreated hypovitaminosis D or hypothyroidism), pulmonary,
   cardiovascular, psychiatric, immunologic/rheumatologic or
   neurologic disease; or have any other severe acute or chronic
   medical or psychiatric condition or laboratory abnormality that
   may increase the risk associated with study participation or
   investigational product administration, or interfere with the
   interpretation of study results; or in the opinion of the investigator
   or Pfizer (or designee), the participant is inappropriate for entry
   into this study, or unwilling/unable to comply with study
   procedures and lifestyle requirements.

  • History of severe allergic or anaphylactoid reaction to any kinase
   inhibitor or a known allergy/hypersensitivity to any component
   (including excipients) of the study intervention.

  • Have hearing loss with progression over the previous 5 years,
   sudden hearing loss, or middle or inner ear disease such as otitis
   media, cholesteatoma, Meniere's disease, labyrinthitis, or other
   auditory condition that is considered current, fluctuating, or
   progressive.

  • Have a history of any lymphoproliferative disorder such as EBV-
   related lymphoproliferative disorder, history of lymphoma, history
   of leukemia, or signs and symptoms suggestive of current
   lymphatic or lymphoid disease.

  • Abnormal findings on the Screening chest imaging (eg, chest x-
   ray). Chest imaging may be performed up to 12 weeks prior to
   screening. Documentation of the official reading must be located
   and available in the source documentation.

  • Long QT Syndrome, a family history of Long QT Syndrome, or a
   history of TdP.

  • Have any malignancies or have a history of malignancies with the
   exception of adequately treated or excised nonmetastatic basal
   cell or squamous cell cancer of the skin or cervical carcinoma in
   situ.

  • Significant trauma or major surgery within 1 month of the first
   dose of study drug or considered in imminent need for surgery or
   with elective surgery scheduled to occur during the study.

Prior/Concomitant Therapy:

6. Have received any of the prohibited treatment regimens specified.
Prior/Concurrent Clinical Study Experience:

7. Previous administration with an investigational drug or vaccine that do not affect vitiligo within 4 weeks of Day 1 [Baseline] or within 5 half-lives, whichever is longer.

Diagnostic Assessments:

Any of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat:

8. Renal impairment

9. Hepatic dysfunction

10. Other laboratory abnormalities

11. Standard 12-lead ECG that demonstrates clinically relevant abnormalities

Other Exclusion Criteria:

12. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Keywords and/or Specific Medical Conditions

  • Dermatology

Sponsors

  • Pfizer

KP Clinical Facility

Clinical Area

  • Dermatology

Principal Investigator

Bhavnit Bhatia , MD 

Contact Information

 - CTP Collaborate Team
- ctpcollaborate@kp.org
- All Kaiser Permanente Northern California Medical Centers

Find a study