Trial · NCT07029711
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | For US and Countries Following US Analysis Plan: Response based on achieving an absolute Severity of Alopecia Tool (SALT) score ≤20. | Week 24 | The difference in proportions of participants with the SALT ≤20 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Primary | For EU/UK and Countries Following EU/UK Analysis Plan: Response based on achieving an absolute SALT score ≤10. | Week 24 | The difference in proportions of participants with the SALT ≤10 response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For EU/UK and Countries Following EU/UK Analysis Plan: Patient Global Impression of Change (PGI-C) response defined as a score of "moderately improved" or "greatly improved". | Week 24 | The difference in proportions of participants with the PGI-C response at Week 24 between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: Change from baseline (CFB) in SALT score. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. | The difference in means/proportions in the SALT Score at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: Response based on achieving absolute SALT score ≤20 at all visits (except for that included as the primary endpoint). | Week 2, Week 4, Week 8, Week 12, Week 18 | The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: Response based on achieving absolute SALT score ≤10 at all visits (except for that included as the primary endpoint). | Week 2, Week 4, Week 8, Week 12, Week 18. | The difference in means/proportions in the endpoint at all scheduled time points (except for that included as the primary endpoints) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: PGI-C response at all visits (except for that included as a key secondary endpoint). | Week 2, Week 4, Week 8, Week 12, Week 18. | The difference in proportions of participants with the PGI-C response at all scheduled time points (except for that included as key secondary endpoint) between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: Response based on improvement from baseline for each Alopecia Areata Patient Priority Outcomes (AAPPO) item. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: CFB in Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy Depressive Symptoms T-score. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: CFB in PROMIS Parent Proxy Anxiety Symptoms T-score. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: CFB in BRIEF®2 T-scores for the 3 index scores (Behavior Regulation Index (BRI), Emotion Regulation Index (ERI), Cognitive Regulation Index (CRI)). | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: CFB in modified Children's Dermatology Life Quality Index (CDLQI) total score. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: Response based on achieving at least 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score in participants with an abnormal EBA at baseline. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. | The difference in proportions of participants with the EBA response at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: Response based on achieving at least 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score in participants with an abnormal ELA at baseline. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. | The difference in proportions of participants with the ELA response at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: Plasma concentration of ritlecitinib. | Post dose hour 1 and hour 3 at day 28 or day 56. | |
| Secondary | For all countries: Incidence of treatment emergent Adverse Events (AEs). | From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 8 months). | To evaluate safety and tolerability of ritlecitinib over time. |
| Secondary | For all countries: Incidence of Serious Adverse Events (SAEs) and AEs leading to permanent discontinuation from the study. | From the time participant signs informed consent/assent, through and including a minimum of 28 calendar days after the last administration of the study intervention (up to approximately 8 months). | To evaluate safety and tolerability of ritlecitinib over time. |
| Secondary | CFB in AAPPO activity limitation score. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
| Secondary | For all countries: Acceptability and palatability assessment. | Week 2 and Week 18 | To evaluate acceptability and palatability of the age-appropriate formulation. |
| Secondary | CFB in AAPPO emotional symptoms score. | Week 2, Week 4, Week 8, Week 12, Week 18, Week 24. | The difference in proportions/ means in the endpoint at all scheduled time points between each ritlecitinib dose and placebo groups in pediatric AA participants defined by the inclusion and exclusion criteria. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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