Trial · NCT04040322

Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)

NCT04040322, Phase 3, 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 3). Trials, record NCT04040322. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04040322

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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 3)
NCT number: NCT04040322
Status: Completed
Phases: Phase 3
Enrollment: 198 participants, actual
Lead sponsor: Civi Biopharma, Inc.
Conditions: Raynaud's Phenomenon Secondary to Systemic Sclerosis
Interventions: Placebo IV infusion, Iloprost Injection, for intravenous use
First posted: 2019-07-31
Last updated: 2025-05-25
Results first posted: 2025-05-25

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 Frequency of Symptomatic RP Attacks	From baseline (Day 10 to Day 25 of screening period) to the end ofthe efficacy follow-up (Day 8 to Day 21).	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
Secondary	Change in Severity of RP Attack Symptoms	From baseline (Day 10 to Day 25 of screening period) to the end of the efficacy follow-up (Day 8 to Day 21).	Change in overall severity of RP attack symptoms as registered in electronic diary. It was measured using an 11-point numeric rating scale (NRS) as follows: 0 = no pain/numbness/tingling/discomfort, 1 to 3 = mild pain/numbness/tingling/discomfort, 4 to 6 = moderate pain/numbness/tingling/discomfort, and 7 to 10 = severe pain/numbness/tingling/discomfort. The severity of the symptoms (pain, numbness, discomfort or tingling) was rated by the patient in the electronic diary (ePRO). The symptom with the worst average baseline value for each patient was compared to the average severity rate of that symptom which occurred during Days 8 to 21 of the treatment period. If more than 1 symptom had the same value, the symptom used for analysis was based on the following order of rank: pain\>numbness\>tingling\>discomfort.
Secondary	Weekly Total Duration of Symptomatic RP Attacks.	From baseline (Day 10 to Day 25 of screening period) to the end of the efficacy follow-up (Day 8 to Day 21).	The weekly duration is calculated as the average duration of a systematic RP attack times weekly frequency, as registered in electronic diary. The baseline weekly duration was calculated as the average duration of a systematic RP attack times weekly frequency during the 10- to 25-day baseline electronic diary completion period. The end of the efficacy follow-up weekly duration of symptomatic RP attacks is calculated as the average duration of a systematic RP attack times weekly frequency during Days 8 to 21, inclusive.
Secondary	Percentage of Responders	From baseline (Day 10 to Day 25 of screening period) to the end of the efficacy follow-up (Day 8 to Day 21).	The responders are defined as participants that have at least 50% reduction in weekly total duration of symptomatic RP attacks and at least 50% reduction in overall severity from baseline. Duration of symptomatic RP attacks and severity of attacks are obtained from electronic diary.

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 Frequency of Symptomatic RP Attacks	From baseline (Day 10 to Day 25 of screening period) to the end ofthe efficacy follow-up (Day 8 to Day 21).	The Intention-To-Treat (ITT) Population was defined as all randomized patients who initiated (received) study drug infusion.	Number of RP attacks per week	LEAST_SQUARES_MEAN
SECONDARY	Change in Severity of RP Attack Symptoms	From baseline (Day 10 to Day 25 of screening period) to the end of the efficacy follow-up (Day 8 to Day 21).	The ITT-To-Treat (ITT) population, defined as all randomized patients who initiated (received) study drug infusion.	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Weekly Total Duration of Symptomatic RP Attacks.	From baseline (Day 10 to Day 25 of screening period) to the end of the efficacy follow-up (Day 8 to Day 21).		Minutes	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Responders	From baseline (Day 10 to Day 25 of screening period) to the end of the efficacy follow-up (Day 8 to Day 21).		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	Spread	Units
Change in Frequency of Symptomatic RP Attacks	Placebo	-11.47	95% Confidence Interval -13.69 to -9.25	Number of RP attacks per week
Change in Frequency of Symptomatic RP Attacks	Iloprost Injection, for Intravenous Use	-12.73	95% Confidence Interval -14.92 to -10.55	Number of RP attacks per week
Change in Severity of RP Attack Symptoms	Placebo	-2.13	95% Confidence Interval -2.51 to -1.75	Score on a scale
Change in Severity of RP Attack Symptoms	Iloprost Injection, for Intravenous Use	-2.19	95% Confidence Interval -2.57 to -1.82	Score on a scale
Weekly Total Duration of Symptomatic RP Attacks.	Placebo	-321.04	95% Confidence Interval -385.03 to -257.05	Minutes
Weekly Total Duration of Symptomatic RP Attacks.	Iloprost Injection, for Intravenous Use	-326.48	95% Confidence Interval -389.53 to -263.44	Minutes
Percentage of Responders	Placebo	33		Participants
Percentage of Responders	Iloprost Injection, for Intravenous Use	33		Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	97
Overall Study	STARTED	Iloprost Injection, for Intravenous Use	99
Overall Study	COMPLETED	Placebo	97
Overall Study	COMPLETED	Iloprost Injection, for Intravenous Use	99
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Iloprost Injection, for Intravenous Use	0

Source ClinicalTrials.gov

Adverse events42

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	38	97	82
other	Headache	Nervous system disorders	Iloprost Injection, for Intravenous Use	85	99	271
other	Dizziness	Nervous system disorders	Placebo	10	97	14
other	Dizziness	Nervous system disorders	Iloprost Injection, for Intravenous Use	10	99	16
other	Head discomfort	Nervous system disorders	Placebo	5	97	11
other	Head discomfort	Nervous system disorders	Iloprost Injection, for Intravenous Use	2	99	5
other	Paraesthesia	Nervous system disorders	Placebo	5	97	8
other	Paraesthesia	Nervous system disorders	Iloprost Injection, for Intravenous Use	1	99	1
other	Nausea	Gastrointestinal disorders	Placebo	15	97	30
other	Nausea	Gastrointestinal disorders	Iloprost Injection, for Intravenous Use	57	99	104

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	97
Total, all-cause mortality	Iloprost Injection, for Intravenous Use	0	99
Total, other adverse events	Placebo	78	97
Total, other adverse events	Iloprost Injection, for Intravenous Use	99	99
Total, serious adverse events	Placebo	0	97
Total, serious adverse events	Iloprost Injection, for Intravenous Use	1	99

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 comparisons3

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

Comparison	Source
Iloprost Injection, for Intravenous Use vs Placebo: Percentage of Responders	Trial comparisons
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/NCT04040322

GET https://conductscience.org/api/trials/v1/NCT04040322/events?page=2

API reference For AI assistants