Trial · NCT03867097

Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)

NCT03867097, Phase 2, Completed, Civi Biopharma, Inc.; results first posted 2025-05-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2). Trials, record NCT03867097. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03867097

On this page

Trial

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

Title: Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)
NCT number: NCT03867097
Status: Completed
Phases: Phase 2
Enrollment: 34 participants, actual
Lead sponsor: Civi Biopharma, Inc.
Conditions: Raynaud Phenomenon Secondary to Systemic Sclerosis
Interventions: Placebo IV infusion, Iloprost Injection, for intravenous use
First posted: 2019-03-07
Last updated: 2025-05-25
Results first posted: 2025-05-25

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Change in Frequency of Symptomatic RP Attacks	Day 8 - Day 21 will be compared to baseline	The primary efficacy parameter is the change in the weekly frequency of symptomatic RP attacks from baseline. The baseline weekly frequency of symptomatic RP attacks was defined as the average number of weekly symptomatic RP attacks that occurred during the 10- to 25-day baseline ePRO diary completion period. The double-blind endpoint weekly frequency of symptomatic RP attacks was defined as the average number of weekly symptomatic RP attacks that occurred during Days 8 to 21, inclusive.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Frequency of Symptomatic RP Attacks	Day 8 - Day 21 will be compared to baseline	The modified Intention-to-Treat (mITT) Population was defined as all randomized subjects who initiated infusion of study drug.	Number of RP attacks per week	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Change in Frequency of Symptomatic RP Attacks	Placebo		-14.32	95% Confidence Interval -20.15 to -8.48	Number of RP attacks per week
Change in Frequency of Symptomatic RP Attacks	Iloprost Injection, for Intravenous Use		-15.09	95% Confidence Interval -21.14 to -9.04	Number of RP attacks per week

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	17
Overall Study	STARTED	Iloprost Injection, for Intravenous Use	17
Overall Study	COMPLETED	Placebo	17
Overall Study	COMPLETED	Iloprost Injection, for Intravenous Use	17
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Iloprost Injection, for Intravenous Use	0

Source ClinicalTrials.gov

Adverse events110

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	Headache	Nervous system disorders	Placebo	5	17	5
other	Headache	Nervous system disorders	Iloprost Injection, for Intravenous Use	16	17	16
other	Dizziness	Nervous system disorders	Placebo	2	17	2
other	Dizziness	Nervous system disorders	Iloprost Injection, for Intravenous Use	1	17	1
other	Dizziness postural	Nervous system disorders	Placebo	1	17	1
other	Dizziness postural	Nervous system disorders	Iloprost Injection, for Intravenous Use	1	17	1
other	Memory impairment	Nervous system disorders	Placebo	0	17	0
other	Memory impairment	Nervous system disorders	Iloprost Injection, for Intravenous Use	1	17	1
other	Presyncope	Nervous system disorders	Placebo	1	17	1
other	Presyncope	Nervous system disorders	Iloprost Injection, for Intravenous Use	0	17	0

1 to 10 of 110Source ClinicalTrials.gov

See all 110 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	17
Total, all-cause mortality	Iloprost Injection, for Intravenous Use	0	17
Total, other adverse events	Placebo	14	17
Total, other adverse events	Iloprost Injection, for Intravenous Use	17	17
Total, serious adverse events	Placebo	0	17
Total, serious adverse events	Iloprost Injection, for Intravenous Use	0	17

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
Iloprost Injection, for Intravenous Use vs Placebo: deaths from any cause	Trial comparisons
Iloprost Injection, for Intravenous Use 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/NCT03867097

GET https://conductscience.org/api/trials/v1/NCT03867097/events?page=2

API reference For AI assistants