Trial · NCT02701634

Efficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD)

NCT02701634, Phase 2, Terminated, Gilead Sciences; results first posted 2018-12-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD). Trials, record NCT02701634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02701634

On this page

Trial

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

Title: Efficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD)
NCT number: NCT02701634
Status: Terminated
Phases: Phase 2
Enrollment: 66 participants, actual
Lead sponsor: Gilead Sciences
Conditions: Chronic Graft Versus Host Disease
Interventions: ENTO, Placebo
First posted: 2016-03-08
Last updated: 2018-12-26
Other registries' IDs: eudract:2015-004572-30
Results first posted: 2018-12-26

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Best Overall Response Rate	Up to 24 weeks	Best overall response rate by 24 weeks was defined as the proportion of participants who achieved a complete or partial overall response as assessed by the NIH cGVHD Activity Assessment (NCAA) within 24 weeks, in the setting of add-on therapy to systemic corticosteroids as part of first-line therapy for cGVHD.
Secondary	Change From Baseline in the Skin Domain of the Lee Symptom Scale (LSS) at 24 Weeks	Baseline; Week 24	The LSS is a patient-reported questionnaire used to measure symptom burden. Each of the LSS subscales ranged between 0 and 100, with higher scores indicating more severe symptoms. A decrease from baseline value correlates with improvement in clinical outcome.
Secondary	Change From Baseline in the Mouth Domain of the LSS at 24 Weeks	Baseline; Week 24	The LSS is a patient-reported questionnaire used to measure symptom burden. Each of the LSS subscales ranged between 0 and 100, with higher scores indicating more severe symptoms. A decrease from baseline value correlates with improvement in clinical outcome.
Secondary	Change From Baseline in the Eyes Domain of the LSS at 24 Weeks	Baseline; Week 24	The LSS is a patient-reported questionnaire used to measure symptom burden. Each of the LSS subscales ranged between 0 and 100, with higher scores indicating more severe symptoms. A decrease from baseline value correlates with improvement in clinical outcome.
Secondary	Change From Baseline in the Total Score of the LSS at 24 Weeks	Baseline; Week 24	The LSS is a patient-reported questionnaire used to measure symptom burden. Each of the LSS subscales ranged between 0 and 100, with higher scores indicating more severe symptoms. The total score was calculated by taking the average of the subscale scores. A decrease from baseline value correlates with improvement in clinical outcome.
Secondary	Duration of Response	Up to 48 weeks	Duration of response was defined as the time from the documentation of best overall response rate to the documentation of progressive disease. Note that flare was not considered as progressive disease in this analysis.
Secondary	Percentage of Participants Who Achieve at Least 50% Reduction in Systemic Corticosteroid Dose Relative to Baseline	Baseline; Up to 48 weeks	The percentage reduction was calculated as (systemic corticosteroid dose post baseline - baseline systemic corticosteroid dose) / baseline systemic corticosteroid dose.
Secondary	Percentage of Participants Who Initiate Second-Line Therapy for cGVHD	Up to 48 weeks	Second-line therapy for cGVHD was defined as receiving any therapy besides systemic corticosteroids or study drug for the treatment of cGVHD. Inhaled and topical steroids are not considered second-line therapy.
Secondary	Failure-Free Survival	Up to 48 weeks	Failure-free survival was defined as the time from randomization to the earliest of first documentation of systemic therapy change, nonrelapse mortality, or recurrent malignancy.
Secondary	Percentage of Participants Who Experience Any Treatment-Emergent Adverse Events (AEs)	Up to 48 weeks plus 30 days	Treatment-emergent adverse events are defined as 1 or both of the following: 1) any AEs with an onset on or after study drug or placebo start date and no later than earlier of 30 days after permanent discontinuation of study drug or placebo, 2) any AEs leading to premature discontinuation of study drug or placebo.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Best Overall Response Rate	Up to 24 weeks	ITT Analysis Set: all participants who were randomized into the study. Data was analyzed according to treatment randomized.	Percentage of participants	NUMBER
SECONDARY	Change From Baseline in the Skin Domain of the Lee Symptom Scale (LSS) at 24 Weeks	Baseline; Week 24	Participants in the ITT Analysis Set with available data were analyzed.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Mouth Domain of the LSS at 24 Weeks	Baseline; Week 24	Participants in the ITT Analysis Set with available data were analyzed.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Eyes Domain of the LSS at 24 Weeks	Baseline; Week 24	Participants in the ITT Analysis Set with available data were analyzed.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Total Score of the LSS at 24 Weeks	Baseline; Week 24	Participants in the ITT Analysis Set with available data were analyzed.	score on a scale	MEAN
SECONDARY	Duration of Response	Up to 48 weeks	ITT Analysis Set	weeks	MEDIAN
SECONDARY	Percentage of Participants Who Achieve at Least 50% Reduction in Systemic Corticosteroid Dose Relative to Baseline	Baseline; Up to 48 weeks	ITT Analysis Set	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Initiate Second-Line Therapy for cGVHD	Up to 48 weeks	ITT Analysis Set	Percentage of participants	NUMBER
SECONDARY	Failure-Free Survival	Up to 48 weeks	Participants in the ITT Analysis Set with available data were analyzed.	Days	MEDIAN
SECONDARY	Percentage of Participants Who Experience Any Treatment-Emergent Adverse Events (AEs)	Up to 48 weeks plus 30 days	Safety Analysis Set: all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual treatment received.	Percentage of participants	NUMBER

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group32

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

Outcome	Group	Category	Value	Spread	Units
Best Overall Response Rate	ENTO		72.7		Percentage of participants
Best Overall Response Rate	Placebo		72.7		Percentage of participants
Change From Baseline in the Skin Domain of the Lee Symptom Scale (LSS) at 24 Weeks	ENTO	Baseline	15.0	Standard Deviation 21.92	units on a scale
Change From Baseline in the Skin Domain of the Lee Symptom Scale (LSS) at 24 Weeks	Placebo	Baseline	19.8	Standard Deviation 22.34	units on a scale
Change From Baseline in the Skin Domain of the Lee Symptom Scale (LSS) at 24 Weeks	ENTO	Change at Week 24	-3.3	Standard Deviation 10.31	units on a scale
Change From Baseline in the Skin Domain of the Lee Symptom Scale (LSS) at 24 Weeks	Placebo	Change at Week 24	-9.4	Standard Deviation 14.24	units on a scale
Change From Baseline in the Mouth Domain of the LSS at 24 Weeks	ENTO	Baseline	15.2	Standard Deviation 18.17	units on a scale
Change From Baseline in the Mouth Domain of the LSS at 24 Weeks	Placebo	Baseline	16.8	Standard Deviation 21.21	units on a scale
Change From Baseline in the Mouth Domain of the LSS at 24 Weeks	ENTO	Change at Week 24	-4.2	Standard Deviation 16.54	units on a scale
Change From Baseline in the Mouth Domain of the LSS at 24 Weeks	Placebo	Change at Week 24	-1.4	Standard Deviation 25.34	units on a scale

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ENTO	33
Overall Study	STARTED	Placebo	33
Overall Study	COMPLETED	ENTO	1
Overall Study	COMPLETED	Placebo	2
Overall Study	NOT COMPLETED	ENTO	32
Overall Study	NOT COMPLETED	Placebo	31

Source ClinicalTrials.gov

Adverse events208

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	Anaemia	Blood and lymphatic system disorders	ENTO	4	32
other	Anaemia	Blood and lymphatic system disorders	Placebo	4	33
other	Lymphopenia	Blood and lymphatic system disorders	ENTO	1	32
other	Lymphopenia	Blood and lymphatic system disorders	Placebo	2	33
other	Neutropenia	Blood and lymphatic system disorders	ENTO	2	32
other	Neutropenia	Blood and lymphatic system disorders	Placebo	2	33
other	Thrombocytopenia	Blood and lymphatic system disorders	ENTO	2	32
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	3	33
other	Tachycardia	Cardiac disorders	ENTO	2	32
other	Tachycardia	Cardiac disorders	Placebo	0	33

1 to 10 of 208Source ClinicalTrials.gov

See all 208 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ENTO	1	32
Total, all-cause mortality	Placebo	0	33
Total, other adverse events	ENTO	31	32
Total, other adverse events	Placebo	30	33
Total, serious adverse events	ENTO	15	32
Total, serious adverse events	Placebo	11	33

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
ENTO vs Placebo: deaths from any cause	Trial comparisons
ENTO 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/NCT02701634

GET https://conductscience.org/api/trials/v1/NCT02701634/results?page=2

API reference For AI assistants