TriangleNCT03570749 · OUTCOME
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Week 36
What was measured
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
Analysis population: All randomized phase 3 participants who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
Groups in this outcome
Placebo Phase 3
Participants received two placebo tablets administered orally every day (QD).
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
| Group | Source count |
|---|---|
| Placebo Phase 3 | 189 |
| 2 mg Baricitinib Phase 3 | 184 |
| 4 mg Baricitinib Phase 3 | 281 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo Phase 3 | 5.3 | Not reported | 2.9 | 9.5 | Not reported |
| 2 mg Baricitinib Phase 3 | 21.7 | Not reported | 16.4 | 28.2 | Not reported |
| 4 mg Baricitinib Phase 3 | 35.2 | Not reported | 29.9 | 41.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 2.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.02
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 5.75
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 5.89
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 23.62
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 11.80
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 2.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 12.02
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 5.75
- statistical Method
- Regression, Logistic
- ci Lower Limit
- 5.89
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 23.62
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- param Type
- Odds Ratio (OR)
- param Value
- 11.80
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.9
- upper Limit
- 9.5
- value
- 5.3
- group Id
- OG001
- lower Limit
- 16.4
- upper Limit
- 28.2
- value
- 21.7
- group Id
- OG002
- lower Limit
- 29.9
- upper Limit
- 41.0
- value
- 35.2
- denoms
- counts
- group Id
- OG000
- value
- 189
- group Id
- OG001
- value
- 184
- group Id
- OG002
- value
- 281
- units
- Participants
- description
- The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received two placebo tablets administered orally every day (QD).
- id
- OG000
- title
- Placebo Phase 3
- description
- Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
- id
- OG001
- title
- 2 mg Baricitinib Phase 3
- description
- Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
- id
- OG002
- title
- 4 mg Baricitinib Phase 3
- param Type
- NUMBER
- population Description
- All randomized phase 3 participants who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
- reporting Status
- POSTED
- time Frame
- Week 36
- title
- Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice