Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04006457) looked at a medicine called ritlecitinib over a long-term period. The main part of the study involved two groups of participants: 449 people who were new to the medicine (the "de novo" group) and 603 people who had already been taking it in an earlier study (the "roll-over" group). A smaller, separate part of the trial involved 17 participants and looked at how the body responds to certain vaccines — specifically a whooping cough/tetanus/diphtheria (Tdap) vaccine and a meningococcal vaccine — while taking ritlecitinib. The trial's primary focus was on monitoring and recording any medical events (called adverse events) that occurred during treatment, as well as tracking measurements like blood pressure, pulse, and laboratory test results. The reported data shows that in the main study, 401 out of 447 treated participants in the de novo group and 515 out of 603 in the roll-over group experienced at least one treatment-emergent adverse event (that is, any medical occurrence that happened after starting the study medicine). Serious adverse events were reported in 30 de novo participants and 42 roll-over participants; adverse events that led to a participant stopping the medicine were reported for 36 and 46 participants in those groups respectively. Abnormal laboratory test results meeting specified thresholds were recorded for 390 de novo participants and 490 roll-over participants. Abnormal vital sign readings (such as unusually low blood pressure or pulse) were also recorded across both groups, with the reported data showing numbers varying by category. For the vaccine sub-study, the reported data shows that 62.5% of participants who received the Tdap vaccine showed a booster response to the tetanus component, as defined by the study's criteria. The secondary outcome data for adverse events until end of study was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 42481842) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Alopecia Areata Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with alopecia areata (a condition causing hair loss) and your hair loss is not caused by anything else — though having common pattern baldness alongside alopecia areata is acceptable.
- If you are aged 12 to under 18, you have lost at least 50% of the hair on your scalp due to alopecia areata (including complete scalp or full-body hair loss).
- If you are aged 18 or older, you have lost at least 25% of the hair on your scalp due to alopecia areata (including complete scalp or full-body hair loss).
- If you are a new participant, you have not had any noticeable hair regrowth on your scalp in the past 6 months.
- If you are a new participant, your current episode of hair loss has been going on for 10 years or less.
Who may not be able to join:
- You have hearing loss that has been getting worse over the past 5 years, or you have experienced sudden hearing loss, or you have an ear condition that is ongoing, changing, or worsening.
- You have a history of cancer or currently have cancer — with the exception of certain skin cancers (basal cell or squamous cell) or early-stage cervical cancer that have been fully treated or removed and have not spread.
- You have had a widespread (affecting a large area of the body) outbreak of herpes zoster (shingles) or herpes simplex (cold sores/related virus) even once, or you have had more than one episode of shingles in a localised area.
- You have had an infection serious enough to require a hospital stay or intravenous/injected antibiotics or antiviral medication within the 6 months before the first study visit.
- You have previously taken a type of medication called a JAK inhibitor (other than the specific drug being studied in this trial), unless your last dose of that medication was more than 12 weeks before your screening appointment.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Pfizer CT.gov Call Center, Pfizer
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Main Study: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Until Follow-up Visit; Main Study: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation Until Follow-up Visit; Main Study: Number of Participants According to Categorization of Vital Signs Data Until Follow-up Visit; Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit; Vaccine Sub-study: Percentage of Participants With Tetanus Booster Response
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.