Trial · NCT05073458
Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia
NCT05073458, Phase 3, Terminated, Incyte Corporation; results first posted 2025-01-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia. Trials, record NCT05073458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05073458
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia
- NCT number
- NCT05073458
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 13 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Warm Autoimmune Hemolytic Anemia (wAIHA)
- Interventions
- parsaclisinib, placebo
- First posted
- 2021-10-11
- Last updated
- 2025-11-03
- Other registries' IDs
- eudract:2021-002844-66
- Results first posted
- 2025-01-15
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Attaining a Durable Hemoglobin Response | up to Week 24 | A durable hemoglobin response was defined as hemoglobin ≥10 grams per deciliter (g/dL) with an increase from Baseline of ≥2 g/dL not attributed to rescue therapy at ≥3 of the 4 available visits at Week 12 and/or later during the 24-week double-blind treatment period. |
| Secondary | Percentage of Participants With a ≥3-point Increase From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 24 | Baseline; Week 24 | The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Percentage of Participants With a 50 Meter Increase From Baseline to Week 24 in a 6-minute Walk Test (6MWT) | Baseline; Week 24 | The 6MWT is used to evaluate submaximal exercise capacity. It is a self-paced measurement of the distance that a participant can quickly walk on a flat, hard surface in a period of 6 minutes. |
| Secondary | Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit | Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56 | The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visit 3 occurred 12 weeks after the end of treatment visit. |
| Secondary | Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit | Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56 | The FACIT-F scale was developed to assess anemia-related fatigue. The FACIT-F is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function over the past 7 days. A clinically meaningful change in the FACIT-F score was defined as ≥3-point increase from Baseline. Item scores range from 0 ("not at all") to 4 ("very much"), and the total score ranges from 0 to 52; lower scores indicate greater fatigue. Percentage change from Baseline was calculated as (\[the post-Baseline value minus the Baseline value\]/Baseline value) x 100. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visit 3 occurred 12 weeks after the end of treatment visit. |
| Secondary | Change From Baseline in Hemoglobin at Each Post-Baseline Visit | Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visits 1, 2, and 3 occurred 4, 8, and 12 weeks, respectively, after the end of treatment visit. |
| Secondary | Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit | Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56 | Percentage change from Baseline was calculated as (\[the post-Baseline value minus the Baseline value\]/Baseline value) x 100. End of Treatment, Double-blind Period: assessment performed for participants who discontinued treatment before Week 24. End of Treatment, Open-label Period: assessment performed for participants who discontinued treatment after Week 24 and before Week 56. Follow-up Visits 1, 2, and 3 occurred 4, 8, and 12 weeks, respectively, after the end of treatment visit. |
| Secondary | Percentage of Participants Who Received Transfusions From Week 6 to Week 24 and From Week 24 to Week 48 | Week 6 to Week 24; Week 24 to Week 48 | Transfusion was permitted as a rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of warm autoimmune hemolytic anemia (wAIHA). |
| Secondary | Change From Baseline in Daily Corticosteroid Dose at Week 24 | Baseline; Week 24 | A new or increased dose of corticosteroids (prednisone or equivalent) from the Day 1 dose was permitted as rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Percentage Change From Baseline in Daily Corticosteroid Dose at Week 24 | Baseline; Week 24 | A new or increased dose of corticosteroids (prednisone or equivalent) from the Day 1 dose was permitted as rescue treatment. Rescue medication was to be considered if the absolute hemoglobin level continued to decline, there was a \> 1 g/dL decrease in hemoglobin from the prior assessment, or the participant developed new or worsening symptoms of wAIHA. Percentage change from Baseline was calculated as (\[the post-Baseline value minus the Baseline value\]/Baseline value) x 100. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Attaining a Durable Hemoglobin Response | up to Week 24 | Safety Analysis Set: all randomized participants who received at least 1 dose of study drug. Treatment groups were determined according to the actual treatment the participant received on Day 1 regardless of assigned study treatment. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a ≥3-point Increase From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 24 | Baseline; Week 24 | Safety Analysis Set. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a 50 Meter Increase From Baseline to Week 24 in a 6-minute Walk Test (6MWT) | Baseline; Week 24 | Safety Analysis Set. Only participants with available data were analyzed, | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit | Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56 | Safety Analysis Set. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Percentage Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit | Baseline; Day 1; Weeks 8, 12, 16, 20, 24, 28, 32, 40, 48, 56, and every 16 weeks post-Week 56 | Safety Analysis Set. Only participants with available data were analyzed, | percentage change | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin at Each Post-Baseline Visit | Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56 | Safety Analysis Set. Only participants with available data were analyzed. | grams per liter | MEAN |
| SECONDARY | Percentage Change From Baseline in Hemoglobin at Each Post-Baseline Visit | Baseline; Day 1; Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and every 8 weeks post-Week 56 | Safety Analysis Set. Only participants with available data were analyzed. | percentage change | MEAN |
| SECONDARY | Percentage of Participants Who Received Transfusions From Week 6 to Week 24 and From Week 24 to Week 48 | Week 6 to Week 24; Week 24 to Week 48 | Safety Analysis Set. Only participants with available data were analyzed. The number of participants analyzed at Weeks 6 to 24 reflects the number of participants who received study drug for at least 43 days. The number of participants analyzed at Weeks 24 to 48 reflects the number of participants who received study drug during the open-label period. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Daily Corticosteroid Dose at Week 24 | Baseline; Week 24 | Safety Analysis Set. Only participants with available data were analyzed. | milligrams | MEAN |
| SECONDARY | Percentage Change From Baseline in Daily Corticosteroid Dose at Week 24 | Baseline; Week 24 | Safety Analysis Set. Only participants with available data were analyzed. | percentage change | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group176
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Attaining a Durable Hemoglobin Response | Parsaclisib | 33.3 | percentage of participants | ||
| Percentage of Participants Attaining a Durable Hemoglobin Response | Placebo | 25.0 | percentage of participants | ||
| Percentage of Participants With a ≥3-point Increase From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 24 | Parsaclisib | 66.7 | percentage of participants | ||
| Percentage of Participants With a ≥3-point Increase From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 24 | Placebo | 50.0 | percentage of participants | ||
| Percentage of Participants With a 50 Meter Increase From Baseline to Week 24 in a 6-minute Walk Test (6MWT) | Placebo | 0.0 | percentage of participants | ||
| Percentage of Participants With a 50 Meter Increase From Baseline to Week 24 in a 6-minute Walk Test (6MWT) | Parsaclisib | 100.0 | percentage of participants | ||
| Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit | Placebo | Baseline | 28.5 | Standard Deviation 5.96 | scores on a scale |
| Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit | Placebo Followed by Parsaclisib | Baseline | 31.3 | Standard Deviation 5.12 | scores on a scale |
| Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit | Parsaclisib | Baseline | 31.1 | Standard Deviation 7.78 | scores on a scale |
| Change From Baseline in the FACIT-F Score at Each Post-Baseline Visit | Placebo | Change from Baseline at Week 8 | 8.2 | Standard Deviation 5.63 | scores on a scale |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 24-week Double-blind Period | STARTED | Parsaclisib | 7 | |
| 24-week Double-blind Period | STARTED | Placebo Followed by Parsaclisib | 6 | |
| 24-week Double-blind Period | COMPLETED | Parsaclisib | 4 | |
| 24-week Double-blind Period | COMPLETED | Placebo Followed by Parsaclisib | 4 | |
| 24-week Double-blind Period | NOT COMPLETED | Parsaclisib | 3 | |
| 24-week Double-blind Period | NOT COMPLETED | Placebo Followed by Parsaclisib | 2 | |
| 24-week Open-label Period | STARTED | Parsaclisib | 4 | |
| 24-week Open-label Period | STARTED | Placebo Followed by Parsaclisib | 4 | |
| 24-week Open-label Period | COMPLETED | Parsaclisib | 2 | |
| 24-week Open-label Period | COMPLETED | Placebo Followed by Parsaclisib | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events104
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Parsaclisib | 1 | 11 | 1 |
| other | Abdominal pain lower | Gastrointestinal disorders | Placebo | 0 | 6 | 0 |
| other | Abdominal pain lower | Gastrointestinal disorders | Parsaclisib | 1 | 11 | 1 |
| other | Alanine aminotransferase increased | Investigations | Placebo | 0 | 6 | 0 |
| other | Alanine aminotransferase increased | Investigations | Parsaclisib | 2 | 11 | 3 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Placebo | 1 | 6 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Parsaclisib | 0 | 11 | 0 |
| other | Amnesia | Nervous system disorders | Placebo | 1 | 6 | 1 |
| other | Amnesia | Nervous system disorders | Parsaclisib | 0 | 11 | 0 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, all-cause mortality | Parsaclisib | 0 | 11 |
| Total, other adverse events | Placebo | 4 | 6 |
| Total, other adverse events | Parsaclisib | 10 | 11 |
| Total, serious adverse events | Placebo | 0 | 6 |
| Total, serious adverse events | Parsaclisib | 6 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Parsaclisib vs Placebo: deaths from any cause | Trial comparisons |
| Parsaclisib vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05073458
GET https://conductscience.org/api/trials/v1/NCT05073458/results?page=2