Trial · NCT05092776
Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine
NCT05092776, Phase 2, Active not recruiting, R-Pharm International, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine. Trials, record NCT05092776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05092776
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine
- NCT number
- NCT05092776
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 84 participants, estimated
- Lead sponsor
- R-Pharm International, LLC
- Conditions
- Familial Mediterranean Fever, FMF
- Interventions
- RPH-104, Placebo
- First posted
- 2021-10-26
- Last updated
- 2024-12-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects with complete response during 16 week therapy with RPH-104 vs. placebo in FMF subjects with colchicine inefficacy or intolerance. | Up to 16 weeks | Complete response defined as resolution of "marker" attack by Visit 2 (Day 7) and lack of recurrent attacks during the treatment period up to Visit 10 (Day 112). Criteria of resolution of a "marker" FMF attack include simultaneous clinical and laboratory signs of the attack resolution: * Physician Global Assessment (PGA) score \< 2 (i.e. minimum or complete lack of clinical signs and symptoms) AND * C-reactive protein (CRP) level ≤ 10 mg/L OR CRP reduction by ≥ 70% compared to baseline defined at enrollment to treatment period (Visit 1). Criteria of a recurrent FMF attack development after resolution of "marker" attack include simultaneous development of clinical and laboratory signs of the attack: * PGA score ≥ 2 assuming mild, moderate or severe disease activity (i.e. clinical signs), AND * CRP level ≥ 30 mg/L (serological signs). PGA is a 5-point scale: from 0 = no disease-related clinical signs and symptoms to 4 = severe clinical signs and symptoms of the disease. |
| Secondary | Time to the development of a recurrent FMF attack in patients with resolved "marker" attacks | from Day 7 to the development of a recurrent FMF attack, up to 16 weeks | Criteria of a recurrent FMF attack development after resolution of "marker" attack include simultaneous development of clinical and laboratory signs of the attack: * PGA score ≥ 2 assuming mild, moderate or severe disease activity (i.e. clinical signs), AND * CRP level ≥ 30 mg/L (serological signs). PGA is a 5-point scale: from 0 = no disease-related clinical signs and symptoms to 4 = severe clinical signs and symptoms of the disease. |
| Secondary | Proportion of subjects with Physician Global Assessment (PGA) score < 2 during the study | Up to 16 weeks | PGA score \< 2 during the treatment period with RPH-104 compared to placebo in FMF subjects with colchicine inefficacy or intolerance. PGA is a 5-point scale from 0 = no disease-related clinical signs and symptoms to 4 = severe clinical signs and symptoms of the disease. |
| Secondary | Proportion of subjects with partial response to treatment | Up to 16 weeks | Partial response defined as Resolution of "marker" attack by Visit 2 (Day 7) but with development of recurrent attacks up to Visit 10 (Day 112). Criteria of resolution of a "marker" FMF attack include simultaneous clinical and laboratory signs of the attack resolution: * Physician Global Assessment (PGA) score \< 2 (i.e. minimum or complete lack of clinical signs and symptoms) AND * CRP level ≤ 10 mg/L OR CRP reduction by ≥ 70% compared to baseline defined at enrollment to treatment period (Visit 1). Criteria of a recurrent FMF attack development after resolution of "marker" attack include simultaneous development of clinical and laboratory signs of the attack: * PGA score ≥ 2 assuming mild, moderate or severe disease activity (i.e. clinical signs), AND * CRP level ≥ 30 mg/L (serological signs). PGA is a 5-point scale: from 0 = no disease-related clinical signs and symptoms to 4 = severe clinical signs and symptoms of the disease. |
| Secondary | Proportion of subjects with serological remission | Up to 16 weeks | Proportion of subjects with serological remission (CRP ≤ 10 mg/L) throughout the study. |
| Secondary | Proportion of subjects with normalized Serum Amyloid A (SAA) level | Up to 16 weeks | Proportion of subjects with normalized serum amyloid A level (SAA \< 10 mg/L) throughout the study |
| Secondary | Proportion of subjects escalated to RPH-104 160 mg q2w dose | Up to 16 weeks | In patients whose treatment group has been unblinded because of a confirmed attack or no "marker" attack resolution: the patients from RPH-104 group and those switching from placebo and receiving RPH-104 at 80 mg dose will be escalated to RPH-104 160 mg q2w. |
| Secondary | Proportion of subjects receiving additional symptomatic therapy with Nonsteroidal anti-inflammatory drugs (NSAIDs), paracetamol or glucocorticoids due to FMF | Up to 16 weeks | Proportion of subjects receiving additional symptomatic therapy with NSAIDs, paracetamol or glucocorticoids due to FMF |
| Secondary | Change in inflammation parameters vs. baseline (CRP) | From baseline (Day 0) up to 18 weeks | Change in CRP levels vs. baseline (Day 0) |
| Secondary | Change in inflammation parameters vs. baseline (SAA) | From baseline (Day 0) up to 18 weeks | Change in SAA levels vs. baseline (Day 0) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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/NCT05092776
GET https://conductscience.org/api/trials/v1/NCT05092776/registered