A Phase 2 interventional study of selexipag (Uptravi) in Pulmonary Arterial Hypertension, sponsored by Actelion. Active, not recruiting at 34 sites in 16 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Actelion (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
Among 12 studies testing selexipag in Pulmonary Arterial Hypertension — 1 open to participants now, 3 under way, 1 of them phase 3. selexipag · Pulmonary Arterial Hypertension.
Among the 12 studies testing selexipag in Pulmonary Arterial Hypertension, this one is the 7th largest by enrollment, is the only one that started in 2018, is one of 2 in phase 2, and was the 7th registered.
699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.
This study's enrollment of 63 is above the median of 40 across 477 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →1 of the 12 studies testing selexipag in Pulmonary Arterial Hypertension is open now, in 12 countries. Each count lists the studies.
selexipag: first FDA approval 2015 (UPTRAVI), first EMA approval 2016. What it is approved for, and how studies give it, is on its page →
Of the 90 Pulmonary Arterial Hypertension studies recruiting now, 51 (57%) set no upper age limit and 24 (27%) stop at 75 or younger; 18 take children under 18; 11 take healthy volunteers.
This study: 2 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2018.
Median enrollment 67 across the 12 interventional studies. Of the 8 that completed or were terminated, 7 (88%) have results posted.
10 of 12 have an industry lead sponsor. The 4 most frequent:
Actelion is the lead sponsor of 143 studies on the registry; 1 is open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 25 (89%) have results posted.
59 studies in Pulmonary Arterial Hypertension by Actelion: 1 open now, 3 under way, 2 of them phase 3. Of 53 finished, 32 (60%) have results posted.
Among the 59 studies in Pulmonary Arterial Hypertension by Actelion, this one is the 26th largest by enrollment of the 49 interventional ones, is one of 2 that started in 2018, is one of 6 in phase 2, and was the 52nd registered.
Actelion’s Pulmonary Arterial Hypertension studies by the year they started, since 2003.
1 of the studies testing selexipag in Pulmonary Arterial Hypertension that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05179876Phase 3ActelionA Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option | 2027-01-31 |
Among the 12 studies testing selexipag in Pulmonary Arterial Hypertension, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Actelion’s 59 in Pulmonary Arterial Hypertension:
Nothing recorded among them since 2026-09-25.
The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.
The selection of the starting dose for pediatric participants is based on the PK extrapolation from adults, taking into account the children body weight category, in order to lead to an exposure similar to that in adult PAH participants at a starting dose of 200 micrograms (mcg). As in adults, selexipag will be up-titrated to the individual maximum tolerated dose (iMTD) during the first 12 weeks. Approximately 60 participants will be enrolled in 3 different age cohorts to obtain at least 45 participants with evaluable PK profiles: Cohort 1: >= 12 to \< 18 years of age, Cohort 2: >= 6 to \< 12 years of age, Cohort 3: >= 2 to \< 6 years of age. In each age cohort the starting dose will depend on the body weight. Enrollment will start with both Cohort 1 and Cohort 2. After completion of PK assessments in at least 15 participants from Cohort 1 at Week 12, a first interim analysis will be conducted to establish the dose-exposure relationship using a population PK model. The PK data from any participants in Cohort 2 who have completed their PK assessments at this time will be included in this first interim analysis. Results of this model-based analysis will be used to confirm or adjust the selexipag doses initially selected. Enrollment of Cohort 3 (children >= 2 to \< 6 years of age) will start once the appropriate doses have been confirmed in a second interim analysis of PK data from Cohorts 1 and 2, and if there is no safety concern based on review by an Independent Data Monitoring Committee (IDMC).
Inclusion Criteria:
PAH with one of the following etiologies:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The first dose of selexipag (Uptravi) will be administered in the evening of Day 1 and will be based on the body weight. Thereafter selexipag will be administered twice daily (morning and evening). Selexipag will be up-titrated during the first 12 weeks, with weekly increments equal to the starting dose until the participants reach their individual maximum tolerated dose (iMTD) or until a maximum dose corresponding to their baseline weight category is achieved (which will be 8-fold of the corresponding starting dose). Up-titration is followed by a stable maintenance treatment period from Week 12 to Week 16, at the maximum tolerated dose. Thereafter, participants will be treated with selexipag as long as the treatment is beneficial to the participants, as per investigator's decision.
Drug: selexipag (Uptravi)
Film-coated tablets for oral administration
Also known as: ACT-293987, JNJ-67896049
Area Under the Plasma Concentration-time Curve Over a Dose Interval at Steady State of Selexipag and Its Metabolite ACT-333679 Combined (AUCτ, ss, Combined)
AUCτ, ss, combined was defined as the area under the plasma concentration-time curve over one dosing interval at steady state. AUCτ,ss,combined was calculated as 1/38 AUCτ,ss,selexipag plus 37/38 AUCτ,ss,ACT-333679.
Time frame: Week 1,Week 12: pre-dose, 1, 2, 4, 6, 8 and 12 h post-morning dose. Week 2, 4 and 6: pre-dose (Up to Week 12)
Area Under the Plasma Concentration-time Curve Over a Dose Interval of Selexipag at Steady State (AUCτ,ss)
Time frame: Week 1,Week 12: pre-dose, 1, 2, 4, 6, 8 and 12 h post-morning dose. Week 2, 4 and 6: pre-dose (Up to Week 12)
Area Under the Plasma Concentration-Time Curve Over a Dose Interval of ACT-333679 at Steady State (AUCτ,ss)
Time frame: Week 1,Week 12: pre-dose, 1, 2, 4, 6, 8 and 12 h post-morning dose. Week 2, 4 and 6: pre-dose (Up to Week 12)
Maximum Observed Plasma Concentration of Selexipag at Steady State (Cmax,ss)
Time frame: Week 1,Week 12: pre-dose, 1, 2, 4, 6, 8 and 12 h post-morning dose. Week 2, 4 and 6: pre-dose (Up to Week 12)
Maximum Observed Plasma Concentration of ACT-333679 at Steady State (Cmax,ss)
Time frame: Week 1,Week 12: pre-dose, 1, 2, 4, 6, 8 and 12 h post-morning dose. Week 2, 4 and 6: pre-dose (Up to Week 12)
Time to Reach the Maximum Observed Plasma Concentration of Selexipag at Steady State (Tmax,ss)
Time frame: Week 1,Week 12: pre-dose, 1, 2, 4, 6, 8 and 12 h post-morning dose. Week 2, 4 and 6: pre-dose (Up to Week 12)
Time to Reach the Maximum Observed Plasma Concentration of ACT-333679 at Steady State (Tmax,ss)
Time frame: Week 1,Week 12: pre-dose, 1, 2, 4, 6, 8 and 12 h post-morning dose. Week 2, 4 and 6: pre-dose (Up to Week 12)
Trough Concentration of Selexipag at Steady State (Ctrough,ss)
Time frame: Week 1,Week 12: pre-dose, 1, 2, 4, 6, 8 and 12 h post-morning dose. Week 2, 4 and 6: pre-dose (Up to Week 12)
Trough Concentration of ACT-333679 at Steady State (Ctrough,ss)
Time frame: Week 1,Week 12: pre-dose, 1, 2, 4, 6, 8 and 12 h post-morning dose. Week 2, 4 and 6: pre-dose (Up to Week 12)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (End of Treatment [EOT] + 3 Days)
Time frame: EOT+3 days (Up to Week 17)
Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) (EOT + 3 Days)
Time frame: EOT+3 days (Up to Week 17)
Number of Participants With Adverse Events (AEs) Leading to Permanent Discontinuation of Study Drug
Time frame: Up to 7 years
Number of Participants With Treatment-emergent Deaths (EOT + 3 Days)
Time frame: EOT+3 days (Up to Week 17)
Number of Participants With Treatment-emergent Marked Laboratory Abnormalities (EOT + 3 Days)
Time frame: EOT+3 days (Up to Week 17)
Change From Baseline in Hematology Parameters (EOT + 3 Days)
Time frame: EOT+3 days (Up to Week 17)
Change From Baseline in Chemistry Parameters (EOT + 3 Days)
Time frame: EOT+3 days (Up to Week 17)
Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities (EOT + 3 Days)
Time frame: EOT+3 days (Up to Week 17)
Change From Baseline in Thyroid Stimulating Hormone (TSH) up to EOT + 3 Days
Time frame: EOT+3 days (Up to Week 17)
Change From Baseline in Blood Pressure
Time frame: Up to 7 years
Change From Baseline in Heart Rate
Time frame: Up to 7 years
Change From Baseline Over Time in Height up to EOT+3 Days
Time frame: EOT+3 days (Up to Week 17)
Change From Baseline Over Time in Body Mass Index (BMI) up to EOT + 3 Days
Time frame: EOT+ 3 days (Up to Week 17)
Change From Baseline in Sexual Maturation (Tanner Stage) up to End of Treatment (EOT + 3 Days)
Time frame: EOT+ 3 days (Up to Week 17)
| Milestone | Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years) | Cohort 2 (>=6 to <12 Years) | Cohort 3 (>=2 to <6 Years) |
|---|---|---|---|
| Started | 22 | 21 | 20 |
| Completed | 0 | 0 | 0 |
| Not completed | 22 | 21 | 20 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Death | 3 | 0 | 3 |
| Withdrew: Lack of efficacy | 1 | 2 | 0 |
| Withdrew: Other | 1 | 0 | 0 |
| Withdrew: Ongoing | 16 | 19 | 17 |
AUCτ, ss, combined was defined as the area under the plasma concentration-time curve over one dosing interval at steady state. AUCτ,ss,combined was calculated as 1/38 AUCτ,ss,selexipag plus 37/38 AUCτ,ss,ACT-333679.
| nanograms*hour per milliliter | Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years) | Cohort 2 (>=6 to <12 Years) | Cohort 3 (>=2 to <6 Years) |
|---|---|---|---|
| Area Under the Plasma Concentration-time Curve Over a Dose Interval at Steady State of Selexipag and Its Metabolite ACT-333679 Combined (AUCτ, ss, Combined) | 21.56 (17.32 to 26.84) | 20.40 (16.83 to 24.73) | 18.57 (15.16 to 22.74) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over Up to 3 years 8 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years) | 3/22 (13.6%) | 12/22 (54.5%) | 21/22 (95.5%) |
| Cohort 2 (>=6 to <12 Years) | 0/21 (0%) | 4/21 (19%) | 20/21 (95.2%) |
| Cohort 3 (>=2 to <6 Years) | 3/20 (15%) | 6/20 (30%) | 17/20 (85%) |
| Event | Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years) | Cohort 2 (>=6 to <12 Years) | Cohort 3 (>=2 to <6 Years) |
|---|---|---|---|
| Covid-19Infections and infestations | 4/22 | 1/21 | 0/20 |
| PneumoniaInfections and infestations | 3/22 | 1/21 | 1/20 |
| Cardiac ArrestCardiac disorders | 0/22 | 0/21 | 2/20 |
| SyncopeNervous system disorders | 1/22 | 0/21 | 2/20 |
| Pulmonary Hypertensive CrisisRespiratory, thoracic and mediastinal disorders | 2/22 | 0/21 | 1/20 |
| GastritisGastrointestinal disorders | 0/22 | 0/21 | 1/20 |
| DeathGeneral disorders | 0/22 | 0/21 | 1/20 |
| BronchitisInfections and infestations | 1/22 | 0/21 | 1/20 |
| Pneumonia AspirationInfections and infestations | 0/22 | 0/21 | 1/20 |
| Urinary Tract InfectionInfections and infestations | 0/22 | 0/21 | 1/20 |
| Event | Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years) | Cohort 2 (>=6 to <12 Years) | Cohort 3 (>=2 to <6 Years) |
|---|---|---|---|
| HeadacheNervous system disorders | 11/22 | 11/21 | 1/20 |
| DiarrhoeaGastrointestinal disorders | 10/22 | 5/21 | 4/20 |
| VomitingGastrointestinal disorders | 8/22 | 9/21 | 7/20 |
| NauseaGastrointestinal disorders | 9/22 | 6/21 | 2/20 |
| Abdominal PainGastrointestinal disorders | 6/22 | 4/21 | 2/20 |
| PyrexiaGeneral disorders | 3/22 | 5/21 | 4/20 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 4/22 | 5/21 | 1/20 |
| FlushingVascular disorders | 5/22 | 2/21 | 0/20 |
| FatigueGeneral disorders | 1/22 | 4/21 | 1/20 |
| DizzinessNervous system disorders | 2/22 | 4/21 | 2/20 |
| Age, Continuous(years) | Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years) | Cohort 2 (>=6 to <12 Years) | Cohort 3 (>=2 to <6 Years) | Total |
|---|---|---|---|---|
| Mean | 14.2 ± 1.79 | 8.5 ± 1.36 | 3.8 ± 1.28 | 9 ± 4.53 |
| Sex: Female, Male(Participants) | Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years) | Cohort 2 (>=6 to <12 Years) | Cohort 3 (>=2 to <6 Years) | Total |
|---|---|---|---|---|
| Female | 15 | 11 | 10 | 36 |
| Male | 7 | 10 | 10 | 27 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years) | Cohort 2 (>=6 to <12 Years) | Cohort 3 (>=2 to <6 Years) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 18 | 19 | 19 | 56 |
| Unknown or Not Reported | 3 | 2 | 1 | 6 |
| Race/Ethnicity, Customized(Participants) | Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years) | Cohort 2 (>=6 to <12 Years) | Cohort 3 (>=2 to <6 Years) | Total |
|---|---|---|---|---|
| Asian | 3 | 6 | 7 | 16 |
| White | 16 | 12 | 11 | 39 |
| Unknown or Not Reported | 3 | 2 | 1 | 6 |
| Other | 0 | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Cohort 1 (Greater Than or Equal to [>=] 12 Years to Less Than [<] 18 Years) | Cohort 2 (>=6 to <12 Years) | Cohort 3 (>=2 to <6 Years) | Total |
|---|---|---|---|---|
| BELARUS | 4 | 2 | 3 | 9 |
| BELGIUM | 0 | 0 | 1 | 1 |
| CHINA | 0 | 1 | 7 | 8 |
| FRANCE | 3 | 1 | 1 | 5 |
| GERMANY | 0 | 1 | 0 | 1 |
| HUNGARY | 1 | 2 | 2 | 5 |
| ISRAEL | 0 | 1 | 2 | 3 |
| MALAYSIA | 3 | 4 | 0 | 7 |
| RUSSIAN FEDERATION | 7 | 0 | 2 | 9 |
| TAIWAN | 0 | 1 | 0 | 1 |
| UKRAINE | 1 | 4 | 0 | 5 |
| UNITED KINGDOM | 0 | 1 | 1 | 2 |
| UNITED STATES | 1 | 2 | 0 | 3 |
| Serbia | 2 | 1 | 1 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Selexipag
Pulmonary Arterial Hypertension →