Trial · NCT03584516
GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
NCT03584516, Phase 2, Phase 3, Terminated, Incyte Corporation; results first posted 2025-01-27
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease. Trials, record NCT03584516. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03584516
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
- NCT number
- NCT03584516
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 155 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Chronic Graft-versus-host Disease
- Interventions
- Itacitinib, Placebo, Methylprednisolone, Prednisone
- First posted
- 2018-07-12
- Last updated
- 2025-10-20
- Other registries' IDs
- eudract:2018-001606-29
- Results first posted
- 2025-01-27
- Limitations and caveats
Based on preliminary data, Part 2 did not enroll participants. All participants in Part 1 Expansion who were on treatment with either itacitinib 300 or 400 milligrams (mg) once daily (QD) and who were tolerating and continuing to receive benefit from itacitinib had the option to continue itacitinib treatment in the INCB 39110-801 (NCT04640025) roll-over study.
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | up to Day 28 | A DLT was defined as the occurrence of any protocol-defined toxicity with onset up to and including Day 28, except those with a clear alternative explanation. Participants who received at least 21 of 28 doses of study drug at the level assigned or had a DLT were considered evaluable for determining tolerability of the dose. Participants who did not achieve this duration of exposure and did not have a DLT were to be replaced for purposes of toxicity identification. |
| Primary | Part 1 Expansion: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | until at least 30 days after the last dose of study treatment (up to 1103 days) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. |
| Primary | Part 2: Response Rate at Month 6 | Month 6 | Response rate was defined as the percentage of participants that had complete response (CR) or partial response (PR), per National Institutes of Health (NIH) Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs. |
| Secondary | Part 1 Expansion: Response Rate at Months 3 and 6 | Months 3 and 6 | Response rate was defined as the percentage of participants that had CR or PR, per NIH Consensus Criteria, as determined by the investigator, within 14 days of the post-Baseline visit date until new anti-GVHD therapy or overall response-progression or relapse/progression of underlying disease. CR was defined as the complete resolution of all signs and symptoms of cGvHD in all evaluable organs. PR was defined as an improvement in at least one organ without progression in other organs. |
| Secondary | Parts 1 and 1 Expansion: Cmax of Itacitinib | Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose | Cmax was defined as the maximum observed concentration of itacitinib. |
| Secondary | Parts 1 and 1 Expansion: Ctau of Itacitinib | Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing) | Ctau was defined as the trough concentration of itacitinib over the dose interval. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28. |
| Secondary | Parts 1 and 1 Expansion: Tmax of Itacitinib | Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing) | tmax was defined as the time to the maximum concentration of itacitinib. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28. |
| Secondary | Parts 1 and 1 Expansion: Cl/F of Itacitinib | Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing) | Cl/F was defined as the apparent oral dose clearance of itacitinib. For pharmacokinetic steady state Day 7 and Day 28, for the calculation of NCA exposure estimates (as more than 3 PK data points are necessary for the estimation beyond Cmax) it was assumed, that PK concentration returns to the predose value (at 12 hours post-dose for BID dosing; at 24 hours post-dose for QD dosing). Predose PK samples were transposed to 24 hours post-dose for QD administration and to 12 hours post-dose for BID administration to allow the steady-state NCA PK estimates on Day 7 and Day 28. |
| Secondary | Part 2: Cmax of Itacitinib | Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose | Cmax was defined as the maximum observed concentration of itacitinib. |
| Secondary | Part 2: Cmin of Itacitinib | Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose | Cmin was defined as the minimum observed plasma or serum concentration of itacitinib over the dose interval. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | up to Day 28 | Safety Analysis Set: all enrolled/randomized participants who received at least 1 dose of study drug and/or reference therapy. Treatment groups for this population were determined according to the actual treatment the participant received regardless of assigned study drug treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1 Expansion: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | until at least 30 days after the last dose of study treatment (up to 1103 days) | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2: Response Rate at Month 6 | Month 6 | Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD. | ||
| SECONDARY | Part 1 Expansion: Response Rate at Months 3 and 6 | Months 3 and 6 | Safety Analysis Set. Confidence intervals were calculated based on the exact method for binomial distributions. | percentage of participants | NUMBER |
| SECONDARY | Parts 1 and 1 Expansion: Cmax of Itacitinib | Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose | Pharmacokinetic (PK) Evaluable Population: all participants who received at least 1 dose of study drug and/or reference therapy and provided at least 1 corresponding post-dose plasma sample (1 PK measurement). Because Part I and Part I Expansion were both randomized, open label, and had a parallel design with the same participant population criteria, as pre-specified, the PK data for identical doses/frequency of dosing were grouped for analysis (rather than conducting analysis by treatment arm). | nanomoles per Liter (nmol/L) | GEOMETRIC_MEAN |
| SECONDARY | Parts 1 and 1 Expansion: Ctau of Itacitinib | Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing) | PK Evaluable Population. Because Part I and Part I Expansion were both randomized, open label, and had a parallel design with the same participant population criteria, as pre-specified, the PK data for identical doses/frequency of dosing were grouped for analysis (rather than conducting analysis by treatment arm). | nmol/L | GEOMETRIC_MEAN |
| SECONDARY | Parts 1 and 1 Expansion: Tmax of Itacitinib | Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing) | PK Evaluable Population. Because Part I and Part I Expansion were both randomized, open label, and had a parallel design with the same participant population criteria, as pre-specified, the PK data for identical doses/frequency of dosing were grouped for analysis (rather than conducting analysis by treatment arm). | hours | MEDIAN |
| SECONDARY | Parts 1 and 1 Expansion: Cl/F of Itacitinib | Day 1: predose, and 1, 2, and 5 hours post-dose. Days 7 and 28: predose, and 1, 2, 5, 12 (for BID dosing), and 24 hours post-dose (for QD dosing) | PK Evaluable Population. Because Part I and Part I Expansion were both randomized, open label, and had a parallel design with the same participant population criteria, as pre-specified, the PK data for identical doses/frequency of dosing were grouped for analysis (rather than conducting analysis by treatment arm). | Liters per hour | GEOMETRIC_MEAN |
| SECONDARY | Part 2: Cmax of Itacitinib | Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose | Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD. | ||
| SECONDARY | Part 2: Cmin of Itacitinib | Days 1, 7, and 28: predose and 1, 2, and 5 hours post-dose | Part 2 was not enrolled because the benefit:risk ratio did not support moving the combination of itacitinib with CS to a later phase of development in first-line cGVHD. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group132
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | Part 1: Itacitinib 200 mg QD + CS | 0 | Participants | ||
| Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | Part 1: Itacitinib 300 mg QD + CS | 1 | Participants | ||
| Part 1 Expansion: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Part 1 Expansion: Itacitinib 300 mg QD + CS | 34 | Participants | ||
| Part 1 Expansion: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Part 1 Expansion: Itacitinib 400 mg QD + CS | 38 | Participants | ||
| Part 1 Expansion: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Part 1 Expansion: Itacitinib 300 mg BID + CS | 28 | Participants | ||
| Part 1 Expansion: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Part 1 Expansion: CS Monotherapy | 32 | Participants | ||
| Part 1 Expansion: Response Rate at Months 3 and 6 | Part 1 Expansion: Itacitinib 300 mg QD + CS | Month 3 | 60.0 | 95% Confidence Interval 42.1 to 76.1 | percentage of participants |
| Part 1 Expansion: Response Rate at Months 3 and 6 | Part 1 Expansion: Itacitinib 400 mg QD + CS | Month 3 | 69.2 | 95% Confidence Interval 52.4 to 83.0 | percentage of participants |
| Part 1 Expansion: Response Rate at Months 3 and 6 | Part 1 Expansion: Itacitinib 300 mg BID + CS | Month 3 | 58.6 | 95% Confidence Interval 38.9 to 76.5 | percentage of participants |
| Part 1 Expansion: Response Rate at Months 3 and 6 | Part 1 Expansion: CS Monotherapy | Month 3 | 50.0 | 95% Confidence Interval 32.9 to 67.1 | percentage of participants |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 | STARTED | Part 1: Itacitinib 200 mg QD + CS | 11 | |
| Part 1 | STARTED | Part 1: Itacitinib 300 mg QD + CS | 10 | |
| Part 1 | STARTED | Part 1 Expansion: Itacitinib 300 mg QD + CS | 0 | |
| Part 1 | STARTED | Part 1 Expansion: Itacitinib 400 mg QD + CS | 0 | |
| Part 1 | STARTED | Part 1 Expansion: Itacitinib 300 mg BID + CS | 0 | |
| Part 1 | STARTED | Part 1 Expansion: CS Monotherapy | 0 | |
| Part 1 | COMPLETED | Part 1: Itacitinib 200 mg QD + CS | 6 | |
| Part 1 | COMPLETED | Part 1: Itacitinib 300 mg QD + CS | 5 | |
| Part 1 | COMPLETED | Part 1 Expansion: Itacitinib 300 mg QD + CS | 0 | |
| Part 1 | COMPLETED | Part 1 Expansion: Itacitinib 400 mg QD + CS | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events1,876
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 distension | Gastrointestinal disorders | Part 1: Itacitinib 200 mg QD + CS | 0 | 11 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Part 1: Itacitinib 300 mg QD + CS | 0 | 10 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Part 1 Expansion: Itacitinib 300 mg QD + CS | 2 | 35 | 2 |
| other | Abdominal distension | Gastrointestinal disorders | Part 1 Expansion: Itacitinib 400 mg QD + CS | 1 | 39 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Part 1 Expansion: Itacitinib 300 mg BID + CS | 2 | 29 | 2 |
| other | Abdominal distension | Gastrointestinal disorders | Part 1 Expansion: Total | 5 | 103 | 5 |
| other | Abdominal distension | Gastrointestinal disorders | Part 1 Expansion: CS Monotherapy | 1 | 36 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Part 1: Itacitinib 200 mg QD + CS | 1 | 11 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Part 1: Itacitinib 300 mg QD + CS | 0 | 10 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Part 1 Expansion: Itacitinib 300 mg QD + CS | 3 | 35 | 3 |
1 to 10 of 1,876Source ClinicalTrials.gov
See all 1,876 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Itacitinib 200 mg QD + CS | 2 | 11 |
| Total, all-cause mortality | Part 1: Itacitinib 300 mg QD + CS | 3 | 10 |
| Total, all-cause mortality | Part 1 Expansion: Itacitinib 300 mg QD + CS | 9 | 35 |
| Total, all-cause mortality | Part 1 Expansion: Itacitinib 400 mg QD + CS | 8 | 39 |
| Total, all-cause mortality | Part 1 Expansion: Itacitinib 300 mg BID + CS | 4 | 29 |
| Total, all-cause mortality | Part 1 Expansion: Total | 21 | 103 |
| Total, all-cause mortality | Part 1 Expansion: CS Monotherapy | 5 | 36 |
| Total, other adverse events | Part 1: Itacitinib 200 mg QD + CS | 11 | 11 |
| Total, other adverse events | Part 1: Itacitinib 300 mg QD + CS | 10 | 10 |
| Total, other adverse events | Part 1 Expansion: Itacitinib 300 mg QD + CS | 33 | 35 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Part 1: Itacitinib 200 mg QD + CS vs Part 1: Itacitinib 300 mg QD + CS: Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) |
Source 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/NCT03584516
GET https://conductscience.org/api/trials/v1/NCT03584516/registered?page=2