Idiopathic Interstitial Pneumonias / Hypertension,PulmonaryPhase 2RISE-IIPNCT02138825
Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)
A Phase 2 study testing Riociguat (Adempas, BAY63-2521) in people with Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary, run by Bayer at 93 sites in 21 countries.
Trial summary
To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary
- What is being tested?
- Riociguat (Adempas, BAY63-2521)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 93 sitesin 21 countries
- Study dates
- 4 Jun 2014to 14 Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged from ≥18 to ≤80 years
- Diagnosed with one of the following (confirmed using a multidisciplinary approach, as per ATS(American Thoracic Society) / ERS(European Respiratory Society) / JRS (Japanese Respiratory Society) / ALAT(Latin American Thoracic Association) guidelines:
- Major IIPs (idiopathic interstitial pneumonias) diagnosis or suspected as one of the following:
- Idiopathic pulmonary fibrosis
- Idiopathic nonspecific interstitial pneumonia
- Respiratory bronchiolitis-interstitial lung disease
Show all 19Show fewer
- Desquamative interstitial pneumonia
- Cryptogenic organizing pneumonia
- Acute interstitial pneumonia
- Rare IIPs diagnosis by one of the following:
- Idiopathic lymphoid interstitial pneumonia
- Idiopathic pleuroparenchymal fibroelastosis
- Unclassifiable idiopathic interstitial pneumonias
- Forced Vital Capacity (FVC) ≥ 45 %
- 6MWD (6 minutes walking distance) ≥ 150 m to ≤ 450 m {under stable O2(oxygen) supplementation via nasal cannula}
- Diagnosis of PH (pulmonary hypertension) confirmed by right heart catheter (RHC) with (mean artery pulmonary artery pressure )mPAP ≥ 25 mmHg and (pulmonary artery wedge pressure)PAWP ≤15 mmHg at rest
- Systolic blood pressure (SBP) ≥ 95 mmHg and no signs or symptoms of hypotension
- WHO functional class II-IV
- Women of childbearing potential can only be included in the study if a pregnancy test is negative. Women of childbearing potential must agree to use adequate contraception when sexually active. 'Adequate contraception' is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). Adequate contraception is required from the signing of the informed consent form up until 4 weeks after the last study drug administration
Who cannot join
- Known significant left heart disease:
- Pulmonary venous hypertension indicated by baseline pulmonary capillary wedge pressure > 15 mmHg
- Symptomatic coronary artery disease
- Systolic left-ventricular dysfunction with an left ventricular ejection fraction (LVEF) <45%
- Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
- Any history of bronchial artery embolization or massive hemoptysis within 3 months prior to screening. Massive hemoptysis being defined as acute bleeding >240 mL in a 24-hour period or recurrent bleeding >100 mL/d over several days
Show all 12Show fewer
- Difference > 15% between the eligibility and the baseline 6MWD test
- Forced expiratory volume in one second (FEV1) / Forced Vital Capacity (FVC) <0.65 after bronchodilator administration
- Initiation in cytotoxic, immunosuppressive, cytokine modulating therapy initiated within 3 months prior to screening. Such agents might include. azathioprine, cyclophosphamide, corticosteroids, etanercept, tumor necrosis factor alpha (TNFα) inhibitors and others
- Any specific treatment for (pulmonary arterial hypertension) PAH/PH (pulmonary hypertension )within 3 months prior to screening
- Concomitant use of the following medication: nitrates or (nitric oxide) NO donors (such as amyl nitrite) in any form, phosphodiesterase 5 inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific phosphodiesterase (PDE) inhibitors (theophylline, dipyridamole),
- Pregnant women (i.e. positive pregnancy test or other signs of pregnancy), or breast feeding women, or women of childbearing potential not using adequate contraception (as defined in the aforementioned inclusion criterion) and not willing to agree to 4 weekly pregnancy testing from Visit 1(first administration of study drug) onwards until 4 weeks after last study drug intake
Trial locations and contacts
93 sites in 21 countries.
93 sites in 21 countries
United States17 sites
Study site
Aurora, Colorado, 80045
Study site
Cincinnati, Ohio, 45219
Study site
Cleveland, Ohio, 44195
Study site
Columbus, Ohio, 43221
Study site
Dallas, Texas, 75235-3858
Study site
Durham, North Carolina, 27710
Study site
Falls Church, Virginia, 22042
University of California, Los Angeles
Los Angeles, California, 90024
Study site
Louisville, Kentucky, 40202
Study site
Miami, Florida, 33136
Study site
Nashville, Tennessee, 37232-5735
Columbia University Medical Center
New York, New York, 10032
Study site
Orlando, Florida, 32803
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Portland, Oregon, 97213
Study site
San Francisco, California, 94143
Via Christi Clinic
Wichita, Kansas, 67208
Germany8 sites
Study site
Dresden, Saxony, 01307
Study site
Essen, North Rhine-Westphalia, 45239
Study site
Giessen, Hesse, 35392
Study site
Großhansdorf, 22927
Study site
Hanover, Lower Saxony, 30625
Study site
München, Bavaria, 80539
Study site
München, Bavaria, 81377
Study site
Würzburg, Bavaria, 97074
Australia7 sites
Study site
Adelaide, South Australia, 5000
Study site
Camperdown, New South Wales, 2050
Study site
Chermside, Queensland, 4032
Study site
Darlinghurst, New South Wales, 2010
Study site
Murdoch, Western Australia, 6150
Study site
Prahran, Victoria, 3181
Study site
Sydney, New South Wales, 2751
Argentina5 sites
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, 1426
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB
Study site
Godoy Cruz, Mendoza Province, 5501
Study site
Mar del Plata, Buenos Aires
Study site
San Miguel de Tucumán, Tucumán Province, 4000
Italy5 sites
Study site
Forlì-Cesena, Emilia-Romagna, 47121
Study site
Monza-Brianza, Lombardy, 20900
Study site
Palermo, Sicily, 90127
Study site
Rome, Lazio, 00133
Study site
Siena, Tuscany, 53100
Japan5 sites
Study site
Chiba, 260-8677
Study site
Sakai, Osaka, 591-8555
Study site
Seto, Aichi-ken, 489-8642
Study site
Shibuya-ku, Tokyo, 151-8528
Study site
Yokohama, Kanagawa, 236-0051
Canada4 sites
Study site
Ottawa, Ontario, K1Y 4W7
Study site
Québec, G1V 4G5
Study site
Toronto, Ontario, M5G 2N2
Study site
Vancouver, British Columbia, V5Z 1M9
Colombia4 sites
Study site
Bogotá, Bogota D.C.
Study site
Bogotá
Study site
Cali, Valle del Cauca Department
Study site
Floridablanca-Bucaramanga, Santander Department
France4 sites
Study site
Bron, 69500
Study site
Lille, 59037
Study site
Marseille, 13915
Study site
Paris, 75908
Greece4 sites
Study site
Athens, 11527
Study site
Haidari, 12462
Study site
Ioannina, 45500
Study site
Thessaloniki, 570 10
Israel4 sites
Study site
Haifa, 3436212
Study site
Jerusalem, 91120
Study site
Petah Tikva, 4941492
Study site
Ramat Gan, 5262000
Russia4 sites
Study site
Moscow, 105077
Study site
Moscow, 107564
Study site
Saint Petersburg, 197022
Study site
Vladimir, 600023
United Kingdom4 sites
Study site
Cambridge, Cambridgeshire, CB23 3RE
Study site
Clydebank, West Dunbartonshire, G81 4DY
Study site
London, SW3 6NP
Study site
Newcastle, NE7 7DN
Portugal3 sites
Study site
Coimbra, 3000-075
Study site
Porto, 4200
Study site
Vila Nova de Gaia, 4434-502
Saudi Arabia3 sites
Study site
Riyadh, 11211
Study site
Riyadh, 11461
Study site
Riyadh, 11525
Spain3 sites
Study site
Barcelona, 08003
Study site
Barcelona, 08036
Study site
Valencia, 46014
Switzerland3 sites
Study site
Bern, 3010
Study site
Geneva, 1205
Study site
Zurich, 8091
Turkey (Türkiye)2 sites
Study site
Denizli, 20070
Study site
Izmir, 35100
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat (0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID) in Patients With Symptomatic Pulmonary Hypertension Associated With Idiopathic Interstitial Pneumonias (IIP).
To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).
Read the detailed description
Number of participants with Adverse Events (AEs) will be reported in Adverse Events section.
- Being tested
- Riociguat (Adempas, BAY63-2521), Placebo
- Medical subject headings
- Idiopathic Interstitial Pneumonias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riociguat (Adempas, BAY63-2521)Drug
Active drug 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration. The starting dose will be 0.5 mg TID, and the dose will be adjusted every two weeks for ten weeks in 0.5 mg increments up to a maximum dose of 2.5 mg TID based on patient's systolic blood pressure and well-being.
PlaceboDrug
Inactive dosed at 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| Riociguat (Adempas, BAY63-2521) | Experimental | In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team. Receives: Drug: Riociguat (Adempas, BAY63-2521) |
| Placebo | Placebo comparator | In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team. Receives: Drug: Riociguat (Adempas, BAY63-2521); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26
The 6MWD test is designed to evaluate a patient's exercise capacity while performing an everyday activity.
Measured: Baseline to 26 weeks
Secondary outcomes (1)
Number of Participants With Clinical Worsening
The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; need for hospitalization due to worsening cardiopulmonary (CP) status, attributable to progression of disease (including but not limited to increased shortness of breath or increased leg swelling); >15% decrease in the 6MWD test; worsening of WHO functional class.
Measured: From baseline to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study start4 Jun 2014
- Primary completion5 May 2016
- Study completion14 Sep 2016
Why it stopped: Study terminated per recommendation of iDMC. On iDMC request, protocol amended to include 4-month safety follow-up for patients after withdrawal of riociguat.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Interstitial Pneumonias / Hypertension,PulmonaryStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138825
- Sponsor's protocol ID
- 13605
- Other IDs
- 2010-024332-42
- Acronym
- RISE-IIP
- Status last verified
- Oct 2017
- First submitted
- 15 Apr 2014
- Last updated
- 4 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nathan SD, Behr J, Collard HR, Cottin V, Hoeper MM, Martinez FJ, Corte TJ, Keogh AM, Leuchte H, Mogulkoc N, Ulrich S, Wuyts WA, Yao Z, Boateng F, Wells AU. Riociguat for idiopathic interstitial pneumonia-associated pulmonary hypertension (RISE-IIP): a randomised, placebo-controlled phase 2b study. Lancet Respir Med. 2019 Sep;7(9):780-790. doi: 10.1016/S2213-2600(19)30250-4. Epub 2019 Aug 12.
PubMed 31416769
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat (0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID) in Patients With Symptomatic Pulmonary Hypertension Associated With Idiopathic Interstitial Pneumonias (IIP).
- ClinicalTrials.gov ID
- NCT02138825
- Acronym / sponsor ID
- RISE-IIP / 13605
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated per recommendation of iDMC. On iDMC request, protocol amended to include 4-month safety follow-up for patients after withdrawal of riociguat.
- Enrolment
- 147 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2014 (actual)
- Primary completion
- 5 May 2016 (actual)
- Study completion
- 14 Sep 2016 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Posted 5 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).
Detailed description
Number of participants with Adverse Events (AEs) will be reported in Adverse Events section.
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 |
|---|---|---|
| Riociguat (Adempas, BAY63-2521) | Experimental | Drug: Riociguat (Adempas, BAY63-2521)In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team. |
| Placebo | Placebo comparator | Drug: Riociguat (Adempas, BAY63-2521), Drug: PlaceboIn the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor's global team. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Men or women aged from ≥18 to ≤80 years
- Diagnosed with one of the following (confirmed using a multidisciplinary approach, as per ATS(American Thoracic Society) / ERS(European Respiratory Society) / JRS (Japanese Respiratory Society) / ALAT(Latin American Thoracic Association) guidelines:
- Forced Vital Capacity (FVC) ≥ 45 %
- 6MWD (6 minutes walking distance) ≥ 150 m to ≤ 450 m {under stable O2(oxygen) supplementation via nasal cannula}
- Diagnosis of PH (pulmonary hypertension) confirmed by right heart catheter (RHC) with (mean artery pulmonary artery pressure )mPAP ≥ 25 mmHg and (pulmonary artery wedge pressure)PAWP ≤15 mmHg at rest
Key exclusion criteria (12 listed)
- Known significant left heart disease:
- Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
- Any history of bronchial artery embolization or massive hemoptysis within 3 months prior to screening. Massive hemoptysis being defined as acute bleeding >240 mL in a 24-hour period or recurrent bleeding >100 mL/d over several days
- Difference > 15% between the eligibility and the baseline 6MWD test
- Forced expiratory volume in one second (FEV1) / Forced Vital Capacity (FVC) <0.65 after bronchodilator administration
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 |
|---|---|---|
| Riociguat (Adempas, BAY63-2521)Active drug 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration. The starting dose will be 0.5 mg TID, and the dose will be adjusted every two weeks for ten weeks in 0.5 mg increments up to a maximum dose of 2.5 mg TID based on patient's systolic blood pressure and well-being. | Drug | Placebo, Riociguat (Adempas, BAY63-2521) |
| PlaceboInactive dosed at 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration for 26 weeks | Drug | Placebo |
Primary outcome
Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26
Time frame: Baseline to 26 weeks
The 6MWD test is designed to evaluate a patient's exercise capacity while performing an everyday activity.
1 secondary outcome
Number of Participants With Clinical Worsening
Time frame: From baseline to week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31416769Nathan SD, Behr J, Collard HR, Cottin V, Hoeper MM, Martinez FJ, Corte TJ, Keogh AM, Leuchte H, Mogulkoc N, Ulrich S, Wuyts WA, Yao Z, Boateng F, Wells AU. Riociguat for idiopathic interstitial pneumonia-associated pulmonary hypertension (RISE-IIP): a randomised, placebo-controlled phase 2b study. Lancet Respir Med. 2019 Sep;7(9):780-790. doi: 10.1016/S2213-2600(19)30250-4. Epub 2019 Aug 12.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
93 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Riociguat (Adempas, BAY63-2521) in people with Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary, run by Bayer at 93 sites in 21 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 19 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, Germany, Australia, Argentina, Italy and 16 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26 (time frame: Baseline to 26 weeks). 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 NCT02138825, 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 4 Dec 2017.