Ulcerative ColitisPhase 1PULSENCT03849599
A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis
A Phase 1 study testing PRV-300 in people with Ulcerative Colitis, run by Provention Bio, Inc. at 3 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis. Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- PRV-300
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 21 Feb 2018to 1 Mar 2019
- Phase
- Phase 1
- 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 aged 18-75 years, inclusive.
- Subject has a clinical diagnosis of UC at least 3 months before screening.
- Subject has moderately to severely active UC, defined as a Mayo score of 6 to 12, inclusive, at screening.
- Subject has a Mayo endoscopic subscore of ≥2 based on central read of the video sigmoidoscopy at screening.
- Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
Who cannot join
- Subject has severe extensive colitis as evidenced by any of the following:
- Current hospitalization for the treatment of UC.
- Investigator judgment that the subject is likely to require a colectomy within 12 weeks of baseline.
- Temperature ≥37.8 ºC (oral or tympanic) and a heart rate >90 bpm.
- Subject has UC limited to <15 cm of the colon.
- Subject has a diagnosis of CD or the presence or history of fistula or indeterminate colitis.
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- Presence of a gastrostomy, jejunostomy, ileostomy or colostomy.
- Subject has had or is expected to have surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions that may confound study evaluations from 2 months before screening through the end of this study.
- Presence of symptomatic colonic or small bowel obstruction
- History of colonic resection
- History of colonic mucosal high-grade dysplasia
- Subject has chronic or recurrent infectious disease
- Subject has positive serology to human immunodeficiency virus (HIV) 1 or 2, hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening.
- Subject has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening).
- Subject has ever received PRV-300 (or CNTO 3157) or has known allergies, hypersensitivity, or intolerance to PRV-300 or its excipients; or known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, to monoclonal antibodies or antibody fragments; or a history of severe allergic reactions, angioedema, or anaphylaxis that might suggest risk for a reaction to a biologic agent.
- Subject 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
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Phase 1b Study to Evaluate the Safety of PRV-300 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis.
Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period.
Read the detailed description
This is a Phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active UC. Randomization will be stratified by Mayo score.
Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period. The total duration of the study will be 20 weeks, excluding the screening period.
The primary objective is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active UC.
The secondary objectives are to evaluate the effect of PRV-300 for 12 weeks in subjects with active UC on:
- Pharmacodynamics: Changes in gene scores in colonic biopsies over the course of treatment.
- Pharmacokinetics: Peak (Cmax) and trough (Cmin) serum concentrations of PRV-300 in subjects with active UC.
- Immunogenicity: Immunogenicity of PRV-300 in subjects with active UC
- Endoscopic: Trends in endoscopic disease activity in subjects with active UC.
- Conditions
- Ulcerative Colitis
- Being tested
- PRV-300, Placebo
- Keywords
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRV-300Biological
Treatment
PlaceboBiological
Control
| Study group | Role | What they receive |
|---|---|---|
| PRV-300 | Experimental | Subjects in this arm will receive the study drug, PRV-300, via IV infusion, followed by an 8-week follow-up period. Receives: Biological: PRV-300 |
| Placebo | Placebo comparator | Subjects in this arm will receive placebo via IV infusion, followed by an 8-week follow-up period. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent adverse events (TEAEs),
Assessment of safety and tolerability
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 posted21 Feb 2019
- Study start21 Feb 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
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 Ulcerative ColitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active UC. Randomization will be stratified by Mayo score.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 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
- NCT03849599
- Sponsor's protocol ID
- PRV-300-UC1b
- Acronym
- PULSE
- Status last verified
- Mar 2019
- First submitted
- 17 Feb 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pokryszka J, Comer GM, Richmond CA, Leon F, Reinisch W. Safety and tolerability of anti-toll-like receptor 3, monoclonal antibody PRV-300 in patients with moderate-to-severe ulcerative colitis: a randomized phase 1B clinical trial (PULSE). J Crohns Colitis. 2026 Oct 9;20(10):jjag154. doi: 10.1093/ecco-jcc/jjag154.
PubMed 42896861
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study to Evaluate the Safety of PRV-300 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03849599
- Acronym / sponsor ID
- PULSE / PRV-300-UC1b
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Provention Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 21 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.
The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis.
Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period.
Detailed description
This is a Phase 1b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active UC. Randomization will be stratified by Mayo score.
Subjects will receive either PRV-300 or placebo treatment. Each group will receive study drug over a total of 12 weeks, followed by an 8-week safety follow-up period. The total duration of the study will be 20 weeks, excluding the screening period.
The primary objective is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active UC.
The secondary objectives are to evaluate the effect of PRV-300 for 12 weeks in subjects with active UC on:
- Pharmacodynamics: Changes in gene scores in colonic biopsies over the course of treatment.
- Pharmacokinetics: Peak (Cmax) and trough (Cmin) serum concentrations of PRV-300 in subjects with active UC.
- Immunogenicity: Immunogenicity of PRV-300 in subjects with active UC
- Endoscopic: Trends in endoscopic disease activity in subjects with active UC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with moderately to severely active UC. Randomization will be stratified by Mayo score.
| Arm | Type | Receives |
|---|---|---|
| PRV-300 | Experimental | Biological: PRV-300Subjects in this arm will receive the study drug, PRV-300, via IV infusion, followed by an 8-week follow-up period. |
| Placebo | Placebo comparator | Biological: PlaceboSubjects in this arm will receive placebo via IV infusion, followed by an 8-week follow-up period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must be a man or woman aged 18-75 years, inclusive.
- Subject has a clinical diagnosis of UC at least 3 months before screening.
- Subject has moderately to severely active UC, defined as a Mayo score of 6 to 12, inclusive, at screening.
- Subject has a Mayo endoscopic subscore of ≥2 based on central read of the video sigmoidoscopy at screening.
- Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
Key exclusion criteria (16 listed)
- Subject has severe extensive colitis as evidenced by any of the following:
- Subject has UC limited to <15 cm of the colon.
- Subject has a diagnosis of CD or the presence or history of fistula or indeterminate colitis.
- Presence of a gastrostomy, jejunostomy, ileostomy or colostomy.
- Subject has had or is expected to have surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions that may confound study evaluations from 2 months before screening through the end of this study.
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-300Treatment | Biological | PRV-300 |
| PlaceboControl | Biological | Placebo |
Primary outcome
Incidence of Treatment-emergent adverse events (TEAEs),
Time frame: 12 weeks
Assessment of safety and tolerability
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 13 Feb 2020.
- Derived from this study: PubMed 42896861Pokryszka J, Comer GM, Richmond CA, Leon F, Reinisch W. Safety and tolerability of anti-toll-like receptor 3, monoclonal antibody PRV-300 in patients with moderate-to-severe ulcerative colitis: a randomized phase 1B clinical trial (PULSE). J Crohns Colitis. 2026 Oct 9;20(10):jjag154. doi: 10.1093/ecco-jcc/jjag154.
- 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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRV-300 in people with Ulcerative Colitis, run by Provention Bio, Inc. at 3 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 5 inclusion and 16 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 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Georgia, Moldova, Ukraine. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Treatment-emergent adverse events (TEAEs), (time frame: 12 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 NCT03849599, 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 13 Feb 2020.