Trial · NCT05107934
Efficacy and Safety of RPH-104 Treatment in Patients With Recurrent Pericarditis
NCT05107934, Phase 2, Phase 3, Suspended, R-Pharm Overseas, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of RPH-104 Treatment in Patients With Recurrent Pericarditis. Trials, record NCT05107934. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05107934
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of RPH-104 Treatment in Patients With Recurrent Pericarditis
- NCT number
- NCT05107934
- Status
- Suspended
- Phases
- Phase 2, Phase 3
- Enrollment
- 80 participants, estimated
- Lead sponsor
- R-Pharm Overseas, Inc.
- Conditions
- Recurrent Pericarditis
- Interventions
- RPH-104, Placebo
- First posted
- 2021-11-04
- Last updated
- 2024-11-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time (days) to the pericarditis recurrence within 24 weeks after randomization in patients with recurrent pericarditis treated with RPH-104 compared to placebo. | up to Week 24 (of the RW period) | Pericarditis recurrence is defined as the occurrence of at least two of the following signs: * at least 1 day of pericarditis pain ≥ 4 (on the 11 point numerical rating scale (NRS)) (without any other potential causes for the increase in the pain intensity); * at least one CRP value ≥ 1 mg/dL (without any other potential causes for the C-reactive protein (CRP elevation)); * new or progression of existing pericardial effusion during the diastole as demonstrated by echocardiography; * evidence of new widespread ST-elevation (ST segment / T wave ratio in lead v6 \> 0.25) or PR depression on electrocardiogram (ECG). Each sign can occur either on the same day or separated by no more than 7 days from another sign. |
| Secondary | Proportion of subjects who maintained Clinical Response at Week 16 of the RW period in RPH-104 group compared to placebo. | up to Week 16 (of the RW period) | Clinical response is defined as a weekly average of daily pericarditis pain on the 11-point NRS ≤ 2 AND CRP level ≤ 0.5 mg/dL, AND absent or mild (\<10 mm) pericardial effusion during the diastole as demonstrated by echocardiography AND absence of new widespread ST-elevation (ST-segment / T-wave ratio in lead v6 \< 0.25), absence of PR depression on ECG AND on monotherapy of randomized study drug at Week 16. (Subjects who had recurrence, discontinued double-blinded treatment, lost to follow-up, and used rescue unblinded RPH-104 or rescue medications (ORT or CSs) before Week 16 will be considered as non-responders.) |
| Secondary | Percentage of days with no or minimal pain in the first 16 weeks of the RW period in RPH-104 group compared to placebo. | up to Week 16 (of the RW period) | No or minimal pain is defined as non-missing NRS ≤ 2. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05107934
GET https://conductscience.org/api/trials/v1/NCT05107934/registered