Trial · NCT03649971
A Study of Guselkumab in Participants With Familial Adenomatous Polyposis
NCT03649971, Phase 1, Completed, Janssen Research & Development, LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Guselkumab in Participants With Familial Adenomatous Polyposis. Trials, record NCT03649971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03649971
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Guselkumab in Participants With Familial Adenomatous Polyposis
- NCT number
- NCT03649971
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 77 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Adenomatous Polyposis Coli
- Interventions
- Guselkumab, Placebo
- First posted
- 2018-08-28
- Last updated
- 2025-02-03
- Other registries' IDs
- eudract:2019-001980-57
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change from Baseline in Rectal/pouch Polyp Burden at Week 24 | Baseline, Week 24 | Percentage change from baseline in rectal/pouch polyp burden (sum of the polyp diameters) at Week 24 will be determined through endoscopy. |
| Secondary | Percentage Change from Baseline in Number of Colorectal Polyps | Baseline, Weeks 24 and 52 | Percentage change from baseline in number of colorectal polyps will be determined. |
| Secondary | Percentage Change from Baseline in Number of J-pouch Polyps | Baseline, Weeks 24 and 52 | Percentage change from baseline in number of J-pouch polyps will be determined. |
| Secondary | Percentage Change from Baseline in J-pouch Polyp Burden | Baseline, Weeks 24 and 52 | Percentage change from baseline in J-pouch polyp burden (sum of polyp diameters) will be determined. |
| Secondary | Percentage Change from Baseline in Number of Duodenal Polyps | Baseline, Weeks 24 and 52 | Percentage change from baseline in number of duodenal polyps will be determined. |
| Secondary | Percentage Change from Baseline in Duodenal Polyp Burden | Baseline, Weeks 24 and 52 | Percentage change from baseline in duodenal polyp burden (sum of polyp diameters) will be determined. |
| Secondary | Change in International Society for Gastrointestinal Hereditary Tumors (InSiGHT) Stage | Baseline, Weeks 24 and 52 | Change in InSiGHT stage will be determined. Various stages of InSiGHT staging system are defined as: Stage 0: 0-10 polyps, all less than (\<)5 millimeter (mm); Stage 1: 10-25 polyps, most \< 5 mm, none greater than (\>) 1 centimeter (cm); Stage 2: 10-25 polyps, any \> 1 cm, amenable to complete removal; Stage 3: \> 25 polyps amenable to complete removal, or any incompletely removed sessile polyp, or any evidence of High-Grade Dysplasia (HGD), even if completely excised; and Stage 4: \> 25 polyps amenable to complete removal, or any incompletely excised sessile polyp showing HGD, any invasive cancer). |
| Secondary | Change in Spigelman Stage Score | Baseline, Weeks 24 and 52 | Change in Spigelman stage score will be determined. Spigelman classification system measures risk of developing duodenal cancer in familial adenomatous polyposis (FAP). It has been classified in following stages- Stage 0 (0 points); Stage 1 (1-4 points); Stage 2 (5-6 points); Stage 3 (7-8 points); and Stage 4 (9-12 points). The total score ranges from 0 to 12. Points are accumulated for polyps' number, size, histology and severity of dysplasia. Stage 1 indicates mild disease, whereas stage 3-4 indicates severe duodenal polyposis. |
| Secondary | Trough Concentration of Guselkumab | Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48 | Serum samples will be analyzed to determine trough concentrations of guselkumab using a validated specific, and sensitive method. |
| Secondary | Number of Participants with Anti-guselkumab Antibodies | Weeks 0, 4, 8, 12, 16, 20, 24, 32, 40, and 48 | Number of participants with Anti-guselkumab antibodies will be determined. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37119510 | DERIVED |
Source PubMed
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/NCT03649971
GET https://conductscience.org/api/trials/v1/NCT03649971/registered