Raynaud's Phenomenon Secondary to Systemic SclerosisPhase 2NCT02260557
Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis
A Phase 2 study testing Selexipag in people with Raynaud's Phenomenon Secondary to Systemic Sclerosis, run by Actelion at 16 sites in 3 countries.
Trial summary
The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Raynaud's Phenomenon Secondary to Systemic Sclerosis
- What is being tested?
- Selexipag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 31 Oct 2014to 30 Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to any study-mandated procedure.
- Male and female subjects aged 18 years and above with a history of recurrent multiple weekly RP attacks secondary to SSc.
- Women of childbearing potential must agree to use a reliable method of birth control.
Who cannot join
- Known moderate or severe hepatic impairment (i.e. Child-Pugh C).
- Known hypersensitivity to selexipag or drugs of the same class, or any of their excipients.
- Subjects who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostenol, iloprost, beraprost) within 3 months prior to the screening visit.
- Subjects who have received a Phosphodiesterase type 5 (PDE-5) inhibitor within 1 week prior to the screening visit.
- Any dose change or initiation of any of the following drugs within 1 month prior to the screening visit: Calcium channel blockers, Nitrates or nitric oxide donors, ERA's, Alpha-blockers, Antithrombotic agents, NSAIDs (occasional use allowed), Angiotensin Converting Enzyme (ACE) inhibitors, Beta-blockers, Clonidine, Systemic corticosteroids, Fluoxetine.
- Severe renal insufficiency (at randomization).
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Germany6 sites
Investigator Site
Bad Nauheim, 61231
Investigator Site
Berlin, 10117
Investigator Site
Cologne, 50937
Investigator Site
Erlangen, 91054
Investigator Site
Magdeburg, 39120
Investigator Site
Mainz, 55131
France5 sites
Investigator Site
Grenoble, 38043
Investigator Site
Lille, 59037
Investigator Site
Nantes, 44093
Investigator Site
Paris, 75679
Investigator Site
Strasbourg, 67200
United Kingdom5 sites
Investigator Site
Bath, BA11RL
Investigator Site
Leeds, LS74SA
Investigator Site
Liverpool, L97AL
Investigator Site
London, NW32QG
Investigator Site
Salford, M55AP
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study to Assess Efficacy and Safety of Selexipag in Adult Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis
The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).
- Being tested
- Selexipag, Placebo
- Keywords
- Systemic Sclerosis, Raynaud's Phenomenon
- Medical subject headings
- Scleroderma, Systemic, Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelexipagDrug
Also called ACT-293987
Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily
PlaceboDrug
Placebo matching selexipag 200 μg tablets to be administered orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Selexipag | Experimental | Selexipag is initiated at 200 µg twice daily (b.i.d.) and up-titrated every 3 days in 200 μg b.i.d. increments up to the maximum tolerated dose (MTD) for each individual patient but not above 1600 µg during the 3-week titration phase. This is followed by a 5-week maintenance phase, during which patients continue the treatment at their individual MTD. Receives: Drug: Selexipag |
| Placebo | Experimental | Placebo matching selexipag tablets is administered according to the same schedule as selexipag Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period
The number of RP attacks is determined from daily entries in electronic Diaries (eDiary).
Measured: From Day 26 to Day 56 ( +/- 7 days)
Secondary outcomes (2)
Number of patients with treatment-emergent adverse events
A treatment-emergent adverse event is any adverse event (AE) temporally associated with the use of a study treatment, whether or not considered related to the study treatment, including any abnormalities in ECG parameters, vital signs or laboratory tests
Measured: Up to end of study (Day 86 +/- 7 days)
Number of patients with treatment-emergent serious adverse events
Measured: Up to end of study (Day 86 +/- 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study start31 Oct 2014
- Primary completion30 Apr 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Raynaud's Phenomenon Secondary to Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Preiss, MD, Study chair, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260557
- Sponsor's protocol ID
- AC-065C202
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2014
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Denton CP, Hachulla E, Riemekasten G, Schwarting A, Frenoux JM, Frey A, Le Brun FO, Herrick AL; Raynaud Study Investigators. Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Randomized, Placebo-Controlled, Phase II Study. Arthritis Rheumatol. 2017 Dec;69(12):2370-2379. doi: 10.1002/art.40242.
PubMed 29193819
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study to Assess Efficacy and Safety of Selexipag in Adult Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT02260557
- Acronym / sponsor ID
- AC-065C202
- Keywords
- Systemic Sclerosis, Raynaud's Phenomenon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2014 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selexipag | Experimental | Drug: SelexipagSelexipag is initiated at 200 µg twice daily (b.i.d.) and up-titrated every 3 days in 200 μg b.i.d. increments up to the maximum tolerated dose (MTD) for each individual patient but not above 1600 µg during the 3-week titration phase. This is followed by a 5-week maintenance phase, during which patients continue the treatment at their individual MTD. |
| Placebo | Experimental | Drug: PlaceboPlacebo matching selexipag tablets is administered according to the same schedule as selexipag |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent prior to any study-mandated procedure.
- Male and female subjects aged 18 years and above with a history of recurrent multiple weekly RP attacks secondary to SSc.
- Women of childbearing potential must agree to use a reliable method of birth control.
Key exclusion criteria (7 listed)
- Known moderate or severe hepatic impairment (i.e. Child-Pugh C).
- Known hypersensitivity to selexipag or drugs of the same class, or any of their excipients.
- Subjects who have received prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostenol, iloprost, beraprost) within 3 months prior to the screening visit.
- Subjects who have received a Phosphodiesterase type 5 (PDE-5) inhibitor within 1 week prior to the screening visit.
- Any dose change or initiation of any of the following drugs within 1 month prior to the screening visit: Calcium channel blockers, Nitrates or nitric oxide donors, ERA's, Alpha-blockers, Antithrombotic agents, NSAIDs (occasional use allowed), Angiotensin Converting Enzyme (ACE) inhibitors, Beta-blockers, Clonidine, Systemic corticosteroids, Fluoxetine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SelexipagAlso: ACT-293987Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily | Drug | Selexipag |
| PlaceboPlacebo matching selexipag 200 μg tablets to be administered orally twice daily | Drug | Placebo |
Primary outcome
Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period
Time frame: From Day 26 to Day 56 ( +/- 7 days)
The number of RP attacks is determined from daily entries in electronic Diaries (eDiary).
2 secondary outcomes
Number of patients with treatment-emergent adverse events
Time frame: Up to end of study (Day 86 +/- 7 days)
Number of patients with treatment-emergent serious adverse events
Time frame: Up to end of study (Day 86 +/- 7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Derived from this study: PubMed 29193819Denton CP, Hachulla E, Riemekasten G, Schwarting A, Frenoux JM, Frey A, Le Brun FO, Herrick AL; Raynaud Study Investigators. Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Randomized, Placebo-Controlled, Phase II Study. Arthritis Rheumatol. 2017 Dec;69(12):2370-2379. doi: 10.1002/art.40242.
Related trials for Raynaud's Phenomenon Secondary to Systemic Sclerosis
Not yet recruitingPhase 3
Efficacy of A Non-Invasive Botulinum Toxin Microneedle Pad for the Treatment of Secondary Raynaud's Phenomenon
Systemic Sclerosis (SSc), Raynaud Disease Secondary to Scleroderma
Not yet recruitingPhase 2
A Study of LIQ861 (Inhaled Treprostinil) in Adults With Systemic Sclerosis Who Have Symptomatic Raynaud's Phenomenon Attacks
Raynaud's Phenomenon Secondary to Systemic Sclerosis
RecruitingPhase 4
Open Label Treprostinil Raynaud's Study
Raynaud's Disease, Raynaud Phenomena
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Preiss, MD study chair
Actelion
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selexipag in people with Raynaud's Phenomenon Secondary to Systemic Sclerosis, run by Actelion at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average number of Raynaud's phenomenon (RP) attacks per week during the maintenance treatment period (time frame: From Day 26 to Day 56 ( +/- 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02260557, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.