Crohn's DiseasePhase 2PRINCENCT03854305
Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease
A Phase 2 study testing PRV-6527 in people with Crohn's Disease, run by Provention Bio, Inc. at 51 sites in 7 countries.
Trial summary
This study will evaluate the efficacy and safety of oral PRV-6527 in the treatment of moderately to severely active Crohn's disease Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- PRV-6527
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 51 sitesin 7 countries
- Study dates
- 20 Mar 2018to 13 Aug 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be a man or woman between 18 years and 75 (inclusive) years of age.
- Has moderate to severe CD and a histologic diagnosis of CD for at least 3 months before screening.
Who cannot join
- Has other gastrointestinal inflammatory diseases.
- Has any malignancy or lymphoproliferative disorder other than nonmelanoma cutaneous malignancies or cervical carcinoma in situ that has been treated with no evidence of recurrence.
- Has colon cancer or severe dysplasia. Subjects with CD for ≥8 years involving the colon are not excluded if they had a colonoscopy to assess for the presence of dysplasia within 1 year before baseline or if they had a colonoscopy at the screening visit that excludes any evidence of malignancy.
- Has current signs or symptoms of an acute infection or infected skin wounds or ulcers, with the exception of nonserious infections in the opinion of the Investigator (e.g. sepsis, pneumonia, or pyelonephritis), including any infection requiring hospitalization or IV antibiotics, within 8 weeks before baseline.
- Has severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
- Has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Trial locations and contacts
51 sites in 7 countries.
51 sites in 7 countries
Ukraine15 sites
Clinical Site
Kharkiv
Clinical site
Khmelnytskyi
Clinical Site 3
Kyiv
Clinical Site2
Kyiv
Clinical Site
Kyiv
Clinical Site2
Lviv
Clinical Site
Lviv
Clinical Site
Odesa
Clinical Site
Ternopil
Clinical Site2
Vinnytsia
Clinical Site3
Vinnytsia
Clinical Site
Vinnytsia
Clinical Site2
Zaporizhzhya
Clinical Site3
Zaporizhzhya
Clinical Site
Zaporizhzhya
Russia10 sites
Clinical site
Kemerovo
Clinical Site
Krasnoyarsk
Clinical Site2
Moscow
Clinical Site
Moscow
Clinical Site
Penza
Clinical site
Rostov-on-Don
Clinical Site
Saint Petersburg
Clinical Site2
Samara
Clinical Site
Samara
Clinical Site
Tomsk
Poland8 sites
Clinical Site
Bydgoszcz
Clinical Site2
Krakow
Clinical Site
Krakow
Clinical Site
Lodz
Clinical Site
Piotrkow Trybunalski
Clinical Site
Warsaw
Clinical Site2
Wroclaw
Clinical site
Wroclaw
Austria5 sites
Clinical Site
Innsbruck
Clinical Site
Klagenfurt
Clinical Site
Sankt Pölten
Clinical Site
Sankt Veit an der Glan
Clinical Site
Vienna
Germany5 sites
Clinical Site
Berlin
Clinical Site
Hamburg
Clinical Site
Kiel
Clinical Site
Landshut
Clinical Site
Ulm
Hungary4 sites
Clinical Site2
Budapest
Clinical Site
Budapest
Clinical Site
Miskolc
Clinical Site
Mosonmagyaróvár
Spain4 sites
ClinicaL Site
Córdoba
Clinical Site
Girona
Clinical Site 2
Madrid
Clinical Site
Madrid
About this study
Official title: Phase 2a Multicenter Randomized Double-Blind Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of CSF-1 Receptor, in Subjects With Moderately to Severely Active Crohn's
This study will evaluate the efficacy and safety of oral PRV-6527 in the treatment of moderately to severely active Crohn's disease
Read the detailed description
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active Crohn's disease.
Eligible subjects include males and females aged 18-75 years with moderately to severely active CD for at least 3 months. Each subject will receive the assigned treatment over 12 weeks, followed by a 4-week safety follow-up period.
- Conditions
- Crohn's Disease
- Being tested
- PRV-6527, Placebo
- Keywords
- Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRV-6527Drug
Treatment
PlaceboDrug
Comparator
| Study group | Role | What they receive |
|---|---|---|
| PRV-6527 | Experimental | Oral administration, 2X daily for 12 weeks Receives: Drug: PRV-6527 |
| Placebo | Placebo comparator | Oral administration, 2X daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 12 in Crohn's Disease Activity Index score
Crohn's Disease Activity Scale will be assessed by collecting information on 8 different Crohn's Disease-related variables : extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stood, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variable are based on dairy of patient for 7 days Scale range is 0 to 600 with 0 being the best oputcome and a score of 600, the worst outcome.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start20 Mar 2018
- Primary completion13 Aug 2019
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provention Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Provention Bio, MD, Study director, Provention Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854305
- Sponsor's protocol ID
- PRV-6527-CD2a
- Other IDs
- 2017-003017-25, 2017
- Acronym
- PRINCE
- Status last verified
- Sep 2021
- First submitted
- 23 Feb 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Multicenter Randomized Double-Blind Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of CSF-1 Receptor, in Subjects With Moderately to Severely Active Crohn's
- ClinicalTrials.gov ID
- NCT03854305
- Acronym / sponsor ID
- PRINCE / PRV-6527-CD2a
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Provention Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 26 Feb 2019 (actual)
- 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.
This study will evaluate the efficacy and safety of oral PRV-6527 in the treatment of moderately to severely active Crohn's disease
Detailed description
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active Crohn's disease.
Eligible subjects include males and females aged 18-75 years with moderately to severely active CD for at least 3 months. Each subject will receive the assigned treatment over 12 weeks, followed by a 4-week safety follow-up period.
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 |
|---|---|---|
| PRV-6527 | Experimental | Drug: PRV-6527Oral administration, 2X daily for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboOral administration, 2X daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject must be a man or woman between 18 years and 75 (inclusive) years of age.
- Has moderate to severe CD and a histologic diagnosis of CD for at least 3 months before screening.
Key exclusion criteria (6 listed)
- Has other gastrointestinal inflammatory diseases.
- Has any malignancy or lymphoproliferative disorder other than nonmelanoma cutaneous malignancies or cervical carcinoma in situ that has been treated with no evidence of recurrence.
- Has colon cancer or severe dysplasia. Subjects with CD for ≥8 years involving the colon are not excluded if they had a colonoscopy to assess for the presence of dysplasia within 1 year before baseline or if they had a colonoscopy at the screening visit that excludes any evidence of malignancy.
- Has current signs or symptoms of an acute infection or infected skin wounds or ulcers, with the exception of nonserious infections in the opinion of the Investigator (e.g. sepsis, pneumonia, or pyelonephritis), including any infection requiring hospitalization or IV antibiotics, within 8 weeks before baseline.
- Has severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
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 |
|---|---|---|
| PRV-6527Treatment | Drug | PRV-6527 |
| PlaceboComparator | Drug | Placebo |
Primary outcome
Change from baseline to Week 12 in Crohn's Disease Activity Index score
Time frame: 12 weeks
Crohn's Disease Activity Scale will be assessed by collecting information on 8 different Crohn's Disease-related variables : extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stood, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variable are based on dairy of patient for 7 days Scale range is 0 to 600 with 0 being the best oputcome and a score of 600, the worst outcome.
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 16 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Provention Bio, MD study director
Provention Bio
51 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRV-6527 in people with Crohn's Disease, run by Provention Bio, Inc. at 51 sites in 7 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 2 inclusion and 6 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Ukraine, Russia, Poland, Austria, Germany and 2 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?
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?
Change from baseline to Week 12 in Crohn's Disease Activity Index score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2021.