Comparison · NCT04006457-32095b72
Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) vs Main Study: Ritlecitinib 50 mg QD (Roll-over Participants): Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) vs Main Study: Ritlecitinib 50 mg QD (Roll-over Participants): Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit. Trial comparisons, record NCT04006457-32095b72. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04006457-32095b72
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.878 | 0.845 | 0.906 | wilson | |
| Risk in group 2 | 0.814 | 0.781 | 0.843 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0644 | 0.0199 | 0.107 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 1.02 | 1.14 | log | |
| Odds ratio, group 1 over group 2 | 1.65 | 1.16 | 2.34 | log | |
| Number needed to treat, for one more participant with the outcome on Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) than on Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | 15.5 | 9.33 | 50.2 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants) | Participants with a clinical diagnosis of AA received ritlecitinib (PF-06651600) 200 mg QD for 4 weeks followed by 50 mg ritlecitinib QD for 35 months during treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. | 390 | 444 | OG000 |
| Group 2 | Main Study: Ritlecitinib 50 mg QD (Roll-over Participants) | Participants with a clinical diagnosis of AA who received ritlecitinib in studies B7931005 (NCT02974868) and B7981015 (NCT03732807) received 50 mg ritlecitinib QD for 36 months in treatment period 1. After completion of treatment period 1, participants not continuing to treatment period 2 entered a follow-up period of 4 weeks. Participants from countries where ritlecitinib was not commercially available continued to receive 50 mg ritlecitinib QD in treatment period 2 for a maximum of 24 months or until availability of commercial product in their country, or until the sponsor terminated the study in that country, whichever occurred first. Participants who permanently discontinued study treatment entered an Observation Period where they completed the scheduled study visits for approximately 2 years or until study end, whichever occurred first. Adolescent participants who did not achieve a SALT score of 20 or less by Month 6 were required to discontinue their participation in the study. | 490 | 602 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Main Study: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values Until Follow-up Visit
- Description
Criteria for laboratory abnormalities included:Hemoglobin, Hematocrit, Erythrocytes (\<0.8\*LLN); Ery. Volume, Hemoglobin,Mean Corpuscular HGB Concentration \<0.8\*LLN or \>1.5\*LLN;Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Neutrophils, Basophils, Eosinophils, Monocytes (\>1.2\*ULN), Prothrombin Time(\>1.1\*ULN).Clinical Chemistry: Bilirubin, Direct Bilirubin, Indirect Bilirubin (1.5\*ULN), Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase (\>3.0\*ULN); Albumin, Urate (\<0.8\*LLN and \>1.2\*ULN; Urea Nitrogen,Creatinine Cholesterol \>1.3\*ULN; Cholesterol \<0.8\*LLN or \>1.2\*LLN, Triglycerides,Potassium,Calcium \< 0.9x LLN \& \> 1.1x ULN; Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite \>=1; Leukocyte Erythrocytes, Leukocytes \>=20; Epithelial Cells\>=6, Hyaline Cast\>1; Bacteria\>20. Number of participants with any laboratory abnormality meeting specified criteria is included.
- Time frame
- From start of study intervention (Day 1) until follow-up visit (4 weeks after last dose in Treatment period 1) (Up to Month 40)
- Population
SAS was defined as all participants who took at least 1 dose of study intervention. Here, the Overall number of participants analyzed signifies the total number of participants evaluable for laboratory abnormalities, i.e. the number with at least one observation of the given laboratory test while on study treatment or during lag time (35 days after the last dose).
Source ClinicalTrials.gov
Trial
- Title
- Long-Term PF-06651600 for the Treatment of Alopecia Areata
- NCT number
- NCT04006457
- Phases
- PHASE3
- Conditions
- Alopecia Areata
- Interventions
- PF-06651600, Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine, Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
- Lead sponsor
- Pfizer
- Results first posted
- 2025-08-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04006457?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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