Trial · NCT07880886
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
NCT07880886, Phase 3, Not yet recruiting, R-Pharm
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever. Trials, record NCT07880886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07880886
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
- NCT number
- NCT07880886
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 18 participants, estimated
- Lead sponsor
- R-Pharm
- Conditions
- Familial Mediterranean Fever, FMF
- Interventions
- RPH-104
- First posted
- 2026-10-19
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum serum concentration of goflikicept (Cmax (W16)) | Visit 1 (Baseline) to Visit 10 (Week 16) | |
| Primary | Area under serum concentration-time curve for goflikicept (AUC(0-W16)) | Visit 1 (Baseline) to Visit 10 (Week 16) | |
| Secondary | Changes in trough serum goflikicept concentration | Visit 1 (Baseline) to Visit 10 (Week 16), and Visit 16 (Week 56) | |
| Secondary | Trough serum steady-state concentration of goflikicept (Cmin,ss) | Visit 1 (Baseline) to Visit 10 (Week 16), and Visit 16 (Week 56) | |
| Secondary | Area under curve for the dosing interval (t) at steady state (ss) after repeated injections (AUC0-t,ss) | Visit 1 (Baseline) to Visit 10 (Week 16), and Visit 16 (Week 56) | |
| Secondary | Time to steady state | Visit 1 (Baseline) to Visit 10 (Week 16), and Visit 16 (Week 56) | |
| Secondary | Percentage of participants with a complete response to treatment | Up to Visit 16 (Week 56) | Complete response is defined as resolution of a "marker" familial Mediterranean fever (FMF) attack by day 7 and the absence of recurrent (new) attacks during the treatment period. |
| Secondary | Change from baseline in PGA (Physician Global Assessment) score | at Visit 1 (Baseline) and Visit 16 (Week 56) | The Physician's Global Assessment (PGA) is an investigator-rated 5-point scale used to evaluate overall disease activity. Scores range from 0 to 4, where: 0 = none; 1 = minimum; 2 = mild; 3 = moderate; 4 = severe signs and symptoms. Higher scores indicate greater disease severity. |
| Secondary | Change from baseline in C-reactive protein (CRP) level | at Visit 1 (Baseline) and Visit 16 (Week 56) | |
| Secondary | Change from baseline in serum amyloid A (SAA) level | at Visit 1 (Baseline) and Visit 16 (Week 56) |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 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/NCT07880886
GET https://conductscience.org/api/trials/v1/NCT07880886/registered?page=2