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Prostacyclin Receptor Agonist

Selexipag for Sarcoidosis (SPHINX Trial)

Phase 2
Waitlist Available
Research Sponsored by Actelion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 26, within 2-5 hours post-dose
Awards & highlights

SPHINX Trial Summary

This trial is testing whether a drug normally used to treat one form of pulmonary hypertension can be effective in treating another form.

Eligible Conditions
  • Sarcoidosis-associated Pulmonary Hypertension

SPHINX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 26, within 2-5 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 26, within 2-5 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pulmonary Vascular Resistance (PVR) on Study Intervention up to Week 26

Side effects data

From 2020 Phase 4 trial • 108 Patients • NCT03078907
77%
Headache
53%
Diarrhoea
42%
Nausea
38%
Pain in Jaw
25%
Vomiting
21%
Arthralgia
21%
Pain in Extremity
13%
Dizziness
11%
Dyspepsia
11%
Upper Respiratory Tract Infection
11%
Myalgia
9%
Flushing
9%
Nasopharyngitis
9%
Fatigue
9%
Nasal Congestion
8%
Dyspnoea
8%
Decreased Appetite
8%
Back Pain
6%
Oedema Peripheral
6%
Cough
6%
Epistaxis
4%
Palpitations
4%
Non-Cardiac Chest Pain
4%
Lower Respiratory Tract Infection
4%
Abdominal Pain Upper
4%
Oropharyngeal Pain
4%
Rash
2%
Respiratory Tract Infection
2%
Atrial Flutter
2%
Right Ventricular Failure
2%
Migraine
2%
Abdominal Distension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Selexipag
Placebo

SPHINX Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Selexipag 200 micro gram (μg)Experimental Treatment1 Intervention
Study intervention will be up-titrated to allow each participant to reach their individual maximum tolerated dose (iMTD), in the range of 200 μg to1600 μg (ie, 1 to 8 tablets) twice daily/once daily. Dosing frequency will be twice daily, except for participants with moderate hepatic impairment (Child-Pugh Class B) or who are concomitantly taking (a) moderate CYP2C8 inhibitor(s), who receive study intervention once daily. The dose will be up-titrated by the investigator/delegate in 200 μg twice daily/once daily increments at weekly intervals during scheduled TCs until reaching the iMTD. If the dose regimen is not well tolerated or symptoms cannot be fully managed with symptomatic treatment, the duration of the titration step can be prolonged to 2 weeks. If needed, the dose can be reduced by 200 μg twice daily/once daily.
Group II: PlaceboPlacebo Group1 Intervention
The comparator will be administered similarly to the experimental intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selexipag
2016
Completed Phase 4
~1750

Find a Location

Who is running the clinical trial?

ActelionLead Sponsor
191 Previous Clinical Trials
35,683 Total Patients Enrolled
1 Trials studying Sarcoidosis
43 Patients Enrolled for Sarcoidosis
Rainer ZimmermannStudy DirectorActelion

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the highest capacity of participants in this research?

"This trial is no longer accepting participants as the study was last updated on November 8th 2022. However, if you are searching for other research studies related to pulmonary hypertension, there are 792 trials actively recruiting and five of those involve Selexipag."

Answered by AI

Are there any vacancies available for those interested in participating in this research?

"This clinical trial is no longer enrolling patients. It was initially posted on February 26th 2021, and the last update came out November 8th 2022. If you're seeking other studies to join, there are 792 pulmonary hypertension trials actively recruiting participants and 5 Selexipag-related experiments currently looking for volunteers."

Answered by AI

What risk factors should be taken into account when prescribing Selexipag?

"In light of the Phase 2 trial, it has been appraised that Selexipag is moderately safe with a rating of 2. However, there is still not enough data to conclusively support its efficacy."

Answered by AI

How many research locations are actively conducting this trial?

"This experiment is primarily conducted at the Jewish General Hospital in Montreal, Icahn School of Medicine at Mount Sinai in New york, and London Health Sciences Centre in Canada. Additionally, there are 12 additional medical sites participating in this trial."

Answered by AI

Does this research represent an original exploration?

"Selexipag is currently being tested in 45 cities and 43 nations worldwide. Actelion’s inaugural trial of this drug, which was finished at the Phase 2 approval stage with 63 participants, commenced back in 2018; since then, a total of 18339 studies have been successfully concluded."

Answered by AI

Does this trial encompass candidates who are younger than seventy-five years of age?

"Those wishing to partake in this clinical trial must be aged 18 and over, but not exceeding 75."

Answered by AI

What other investigations have been conducted into the efficacy of Selexipag?

"At present, there are 5 clinical trials researching Selexipag with 2 of them currently in Phase 3. Of these 335 sites across Brasília and Arizona offering the treatment, most have been situated in the former region."

Answered by AI

Who qualifies to participate in this clinical experiment?

"This clinical trial seeks 10 participants who are aged 18-75 with pulmonary hypertension. All other criteria must be met for successful recruitment."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

What questions have other patients asked about this trial?

How long is this trial?
PatientReceived no prior treatments

Why did patients apply to this trial?

I have Sarcoidosis for over 12 years and would love to help not only me but others with the findings and hopefully help the Sarcoidosis community with a new drug.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag
2021. "A Study in Participants With Sarcoidosis-associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03942211.
~2 spots leftby Apr 2025
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