Trial · NCT03764618

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA

NCT03764618, Phase 3, Completed, Rigel Pharmaceuticals; results first posted 2023-05-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA. Trials, record NCT03764618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03764618

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA
NCT number: NCT03764618
Status: Completed
Phases: Phase 3
Enrollment: 90 participants, actual
Lead sponsor: Rigel Pharmaceuticals
Conditions: Warm Antibody Autoimmune Hemolytic Anemia
Interventions: Fostamatinib disodium, Placebo
First posted: 2018-12-05
Last updated: 2023-05-25
Results first posted: 2023-05-25

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Durable Hemoglobin Response	24 Weeks	Proportion of subjects achieving a hemoglobin level ≥ 10 g/dL with an increase from Baseline in hemoglobin level of ≥ 2 g/dL on 3 consecutive available visits during the 24-week treatment period.
Secondary	A Hemoglobin Response by Week 24	24 weeks	Proportion of subjects with a hemoglobin response by Week 24.
Secondary	Change From Baseline in Hemoglobin Level of 2 g/dL or Greater	24 weeks	Proportion of subjects with change from baseline in hemoglobin level of 2 g/dL or greater.
Secondary	Change in Hemoglobin From Baseline to End of Treatment	24 weeks	Change in mean hemoglobin from baseline to end of treatment.
Secondary	Use of Rescue Antibody Autoimmune Hemolytic Anemia (AIHA) Regimens Use After Week 4	24 weeks	Proportion of subjects free of rescue AIHA regimens used after Week 4.
Secondary	Change in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)	24 weeks	Change from Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-F). The FACIT-F scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. Each item is rated using a 5-point Likert-type scale. The scale range is 0 to 52, with 0 being the worst possible score and 52 being the best possible score indicating no fatigue. Total Score = \[Sum of item scores\] x \[N of items in subscale\] ÷ \[N of items answered\].

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Durable Hemoglobin Response	24 Weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	A Hemoglobin Response by Week 24	24 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Hemoglobin Level of 2 g/dL or Greater	24 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Hemoglobin From Baseline to End of Treatment	24 weeks	Of the 72 completed participants, 11 participants were excluded due to hemoglobin value missing or not being eligible during the evaluation period.	g/dL	MEAN
SECONDARY	Use of Rescue Antibody Autoimmune Hemolytic Anemia (AIHA) Regimens Use After Week 4	24 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F)	24 weeks	The analysis population includes the intent-to-treat (ITT) population.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Durable Hemoglobin Response	Fostamatinib	16		Participants
Durable Hemoglobin Response	Placebo	12		Participants
A Hemoglobin Response by Week 24	Fostamatinib	21		Participants
A Hemoglobin Response by Week 24	Placebo	16		Participants
Change From Baseline in Hemoglobin Level of 2 g/dL or Greater	Fostamatinib	22		Participants
Change From Baseline in Hemoglobin Level of 2 g/dL or Greater	Placebo	16		Participants
Change in Hemoglobin From Baseline to End of Treatment	Fostamatinib	1.99	Standard Deviation 2.095	g/dL
Change in Hemoglobin From Baseline to End of Treatment	Placebo	1.99	Standard Deviation 2.468	g/dL
Use of Rescue Antibody Autoimmune Hemolytic Anemia (AIHA) Regimens Use After Week 4	Fostamatinib	18		Participants
Use of Rescue Antibody Autoimmune Hemolytic Anemia (AIHA) Regimens Use After Week 4	Placebo	18		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Fostamatinib	45
Overall Study	STARTED	Placebo	45
Overall Study	COMPLETED	Fostamatinib	38
Overall Study	COMPLETED	Placebo	34
Overall Study	NOT COMPLETED	Fostamatinib	7
Overall Study	NOT COMPLETED	Placebo	11

Source ClinicalTrials.gov

Adverse events122

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
other	Warm type hemolytic anemia	Blood and lymphatic system disorders	Fostamatinib	16	45
other	Warm type hemolytic anemia	Blood and lymphatic system disorders	Placebo	14	45
other	Anemia	Blood and lymphatic system disorders	Fostamatinib	4	45
other	Anemia	Blood and lymphatic system disorders	Placebo	5	45
other	Fatigue	General disorders	Fostamatinib	7	45
other	Fatigue	General disorders	Placebo	5	45
other	Asthenia	General disorders	Fostamatinib	4	45
other	Asthenia	General disorders	Placebo	6	45
other	Pyrexia	General disorders	Fostamatinib	6	45
other	Pyrexia	General disorders	Placebo	3	45

1 to 10 of 122Source ClinicalTrials.gov

See all 122 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fostamatinib	2	45
Total, all-cause mortality	Placebo	3	45
Total, other adverse events	Fostamatinib	42	45
Total, other adverse events	Placebo	40	45
Total, serious adverse events	Fostamatinib	15	45
Total, serious adverse events	Placebo	17	45

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 comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Fostamatinib vs Placebo: A Hemoglobin Response by Week 24	Trial comparisons
Fostamatinib vs Placebo: Change From Baseline in Hemoglobin Level of 2 g/dL or Greater	Trial comparisons
Fostamatinib vs Placebo: Use of Rescue Antibody Autoimmune Hemolytic Anemia (AIHA) Regimens Use After Week 4	Trial comparisons
Fostamatinib vs Placebo: Durable Hemoglobin Response	Trial comparisons
Fostamatinib vs Placebo: deaths from any cause	Trial comparisons
Fostamatinib 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03764618

GET https://conductscience.org/api/trials/v1/NCT03764618/events?page=2

API reference For AI assistants