Trial · NCT04854096

Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis

NCT04854096, Phase 2, Terminated, NS Pharma, Inc.; results first posted 2025-05-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis. Trials, record NCT04854096. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04854096

On this page

Trial

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

Title: Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis
NCT number: NCT04854096
Status: Terminated
Phases: Phase 2
Enrollment: 7 participants, actual
Lead sponsor: NS Pharma, Inc.
Conditions: Primary Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Post-polycythemia Vera Myelofibrosis
Interventions: NS-018, Best Available Therapy
First posted: 2021-04-22
Last updated: 2025-05-23
Results first posted: 2025-05-23
Limitations and caveats: The study was stopped early for business reasons. Therefore the efficacy outcomes were evaluated only in the limited number of patients enrolled.

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Change in Spleen Volume	baseline and week 24	Proportion of subjects who achieve ≥35% reduction in spleen volume from baseline compared to Week 24 as measured by MRI (or by CT for applicable subjects)
Primary	Change in Total Symptom Score (TSS)	baseline and week 24	Proportion of subjects who achieve ≥50% reduction in total symptom score from baseline compared to Week 24 as measured by the MF-SAF v4.0
Secondary	Change in Spleen Volume	from baseline to anytime before or at week 24	Proportion of subjects in NS-018 vs BAT arm who achieve ≥35% reduction in spleen volume from baseline at any time up to Week 24 as measured by MRI (or by CT for applicable subjects)
Secondary	Comparison of Treatment-emergent AEs Between NS-018 and BAT	from baseline to week 24	Laboratory events graded by the NCI CTCAE v5.0 will be assessed in both arms, to compare the safety profile of NS-018 versus BAT.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Spleen Volume	baseline and week 24	The primary outcome measure for an efficacy endpoint to compare the efficacy of NS-018 to the Best Available Therapy (BAT) was analyzed among the limited participants enrolled before the study was terminated early for business reasons.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change in Total Symptom Score (TSS)	baseline and week 24	This co-primary outcome measure for an efficacy endpoint to compare NS-018 to the Best Available Therapy (BAT) was analyzed among the limited participants enrolled before the study was terminated early for business reasons. .	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Spleen Volume	from baseline to anytime before or at week 24	This secondary outcome measure for an efficacy endpoint to compare the efficacy of NS-018 to the Best Available Therapy (BAT) was analyzed among the limited participants enrolled before the study was terminated early for business reasons.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Comparison of Treatment-emergent AEs Between NS-018 and BAT	from baseline to week 24	TEAE's were evaluated in the participants who received NS-018 or BAT.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Units
Change in Spleen Volume	NS-018	0	Participants
Change in Spleen Volume	Best Available Therapy (BAT)	0	Participants
Change in Total Symptom Score (TSS)	NS-018	0	Participants
Change in Total Symptom Score (TSS)	Best Available Therapy (BAT)	1	Participants
Change in Spleen Volume	NS-018	1	Participants
Change in Spleen Volume	Best Available Therapy (BAT)	0	Participants
Comparison of Treatment-emergent AEs Between NS-018 and BAT	NS-018	5	Participants
Comparison of Treatment-emergent AEs Between NS-018 and BAT	Best Available Therapy (BAT)	2	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	NS-018	5
Overall Study	STARTED	Best Available Therapy (BAT)	2
Overall Study	COMPLETED	NS-018	0
Overall Study	COMPLETED	Best Available Therapy (BAT)	0
Overall Study	NOT COMPLETED	NS-018	5
Overall Study	NOT COMPLETED	Best Available Therapy (BAT)	2

Source ClinicalTrials.gov

Adverse events92

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	Anaemia	Blood and lymphatic system disorders	NS-018	4	5	8
other	Anaemia	Blood and lymphatic system disorders	Best Available Therapy (BAT)	0	2	0
other	Platelet Count Decrease	Investigations	NS-018	2	5	2
other	Platelet Count Decrease	Investigations	Best Available Therapy (BAT)	0	2	0
other	Conjunctival haemorrhage	Eye disorders	NS-018	1	5	1
other	Conjunctival haemorrhage	Eye disorders	Best Available Therapy (BAT)	1	2	1
other	Hematochezia	Gastrointestinal disorders	NS-018	1	5	1
other	Hematochezia	Gastrointestinal disorders	Best Available Therapy (BAT)	0	2	0
other	Influenza	Infections and infestations	NS-018	2	5	2
other	Influenza	Infections and infestations	Best Available Therapy (BAT)	0	2	0

1 to 10 of 92Source ClinicalTrials.gov

See all 92 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NS-018	0	5
Total, all-cause mortality	Best Available Therapy (BAT)	0	2
Total, other adverse events	NS-018	5	5
Total, other adverse events	Best Available Therapy (BAT)	2	2
Total, serious adverse events	NS-018	1	5
Total, serious adverse events	Best Available Therapy (BAT)	0	2

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
NS-018 vs Best Available Therapy (BAT): Change in Spleen Volume	Trial comparisons
NS-018 vs Best Available Therapy (BAT): Change in Spleen Volume	Trial comparisons
NS-018 vs Best Available Therapy (BAT): Change in Total Symptom Score (TSS)	Trial comparisons
NS-018 vs Best Available Therapy (BAT): deaths from any cause	Trial comparisons
NS-018 vs Best Available Therapy (BAT): Comparison of Treatment-emergent AEs Between NS-018 and BAT	Trial comparisons
NS-018 vs Best Available Therapy (BAT): 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/NCT04854096

GET https://conductscience.org/api/trials/v1/NCT04854096/events?page=2

API reference For AI assistants