NCT02435992 is a Phase 3 clinical trial of RPC1063 in Ulcerative Colitis, sponsored by Celgene.

Who is sponsoring NCT02435992?

NCT02435992 is sponsored by Celgene.

What drugs are being tested in NCT02435992?

Interventions in NCT02435992: RPC1063, Placebo.

What condition does NCT02435992 study?

NCT02435992 studies Ulcerative Colitis.

Is NCT02435992 still recruiting?

NCT02435992 is currently completed. Last updated 1 September 2021.

Are results published for NCT02435992?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-09-01 · How we verify

NCT02435992

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

Completed Phase 3 Results posted Last updated 1 September 2021

What this trial tests

Phase 3 trial testing RPC1063 in Ulcerative Colitis in 1,012 participants. Completed in 17 June 2020.

Timeline

17 June 2015

Primary endpoint
27 March 2020

17 June 2020

Quick facts

Lead sponsor	Celgene
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,012
Start date	17 June 2015
Primary completion	27 March 2020
Estimated completion	17 June 2020
Sites	372 locations across Italy, Poland, South Korea, Croatia, New Zealand, Netherlands, Russia, Belgium

Drugs / interventions tested

RPC1063 — full drug profile →
Placebo

Conditions studied

Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Celgene — full company profile →

Who can join

Adults 18 to 75, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants in Clinical Remission at 10 Weeks Primary · At 10 Weeks

Percentage of participants that are in Clinical remission at 10 weeks

Group	Value	95% CI
RPC1063 Cohort 1(Induction Period)	18.4
Placebo Cohort 1 (Induction Period)	6.0
RPC1063 Cohort 2 (Induction Period)	21.0

Percentage of Participants in Clinical Remission at 52 Weeks Primary · At 52 Weeks

Percentage of participants that are in Clinical remission at 52 weeks

Group	Value	95% CI
Placebo Cohort 1 (Induction Period)	24.6
RPC1063 (Maintenance Period)	37.0
Placebo (Maintenance Period)	18.5

Percentage of Participants With Clinical Response at 10 Weeks Secondary · At 10 Weeks

Percentage of participants that are in Clinical response at 10 weeks

Group	Value	95% CI
RPC1063 Cohort 1(Induction Period)	47.8
Placebo Cohort 1 (Induction Period)	25.9
RPC1063 Cohort 2 (Induction Period)	52.6

Percentage of Participants With Endoscopic Improvement at 10 Weeks Secondary · At 10 Weeks

Percentage of participants with endoscopic improvement at 10 weeks

Group	Value	95% CI
RPC1063 Cohort 1(Induction Period)	27.3
Placebo Cohort 1 (Induction Period)	11.6
RPC1063 Cohort 2 (Induction Period)	27.2

Percentage of Participants With Mucosal Healing at 10 Weeks Secondary · At 10 Weeks

Percentage of participants with mucosal healing at 10 weeks

Group	Value	95% CI
RPC1063 Cohort 1(Induction Period)	12.6
Placebo Cohort 1 (Induction Period)	3.7
RPC1063 Cohort 2 (Induction Period)	11.4

Percentage of Participants in Clinical Response at 52 Weeks Secondary · At 52 Weeks

Percentage of participants that are in Clinical response at 52 weeks

Group	Value	95% CI
Placebo Cohort 1 (Induction Period)	39.1
RPC1063 (Maintenance Period)	60.0
Placebo (Maintenance Period)	41.0

Percentage of Participants With Endoscopic Improvement at 52 Weeks Secondary · At 52 Weeks

Percentage of participants with endoscopic improvement at 52 weeks

Group	Value	95% CI
Placebo Cohort 1 (Induction Period)	29.0
RPC1063 (Maintenance Period)	45.7
Placebo (Maintenance Period)	26.4

Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10 Secondary · At 52 Weeks

Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10

Group	Value	95% CI
Placebo Cohort 1 (Induction Period)	41.7
RPC1063 (Maintenance Period)	51.9
Placebo (Maintenance Period)	29.3

Percentage of Participants With Corticosteroid Free Remission at 52 Weeks Secondary · At 52 Weeks

Percentage of participants with corticosteroid free remission at 52 weeks

Group	Value	95% CI
Placebo Cohort 1 (Induction Period)	24.6
RPC1063 (Maintenance Period)	31.7
Placebo (Maintenance Period)	16.7

Percentage of Participants With Mucosal Healing at 52 Weeks Secondary · At 52 Weeks

Percentage of participants with Mucosal Healing at 52 weeks

Group	Value	95% CI
Placebo Cohort 1 (Induction Period)	10.1
RPC1063 (Maintenance Period)	29.6
Placebo (Maintenance Period)	14.1

Percentage of Participants With Durable Clinical Remission at 52 Weeks Secondary · At 52 Weeks

Percentage of participants with durable clinical remission at 52 weeks

Group	Value	95% CI
Placebo Cohort 1 (Induction Period)	7.2
RPC1063 (Maintenance Period)	17.8
Placebo (Maintenance Period)	9.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Approximately up to 52 Weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1 (Induction Period): RPC1063 1mg

Serious: 17/429 (4%)

Deaths: 0/429

Cohort 1: Placebo

Serious: 11/216 (5%)

Deaths: 0/216

Cohort 2 (Induction Period): RPC1063 1mg

Serious: 23/367 (6%)

Deaths: 1/367

Intervention (Maintenance Period): RPC1063 1mg

Serious: 12/230 (5%)

Deaths: 0/230

Placebo (Maintenance Period): Placebo

Serious: 18/227 (8%)

Deaths: 0/227

Serious adverse events (55 terms)

Reaction	System	Cohort 1 (Induction Period…	Cohort 1: Placebo	Cohort 2 (Induction Period…	Intervention (Maintenance …	Placebo (Maintenance Perio…
Colitis ulcerative	Gastrointestinal disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—
Complicated appendicitis	Infections and infestations	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—	—
Coronary artery stenosis	Cardiac disorders	—	—	—	—	—
Pericarditis	Cardiac disorders	—	—	—	—	—
Cataract	Eye disorders	—	—	—	—	—
Photophobia	Eye disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Diarrhoea haemorrhagic	Gastrointestinal disorders	—	—	—	—	—
Enterocolitis	Gastrointestinal disorders	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—
Haemorrhoids	Gastrointestinal disorders	—	—	—	—	—
Melaena	Gastrointestinal disorders	—	—	—	—	—
Proctitis ulcerative	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—	—	—
Food allergy	Immune system disorders	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—
Clostridium difficile infection	Infections and infestations	—	—	—	—	—
Gastroenteritis norovirus	Infections and infestations	—	—	—	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Cohort 1 (Induction Period…	Cohort 1: Placebo	Cohort 2 (Induction Period…	Intervention (Maintenance …	Placebo (Maintenance Perio…
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—

Most-reported serious reactions: Colitis ulcerative, Anaemia, Appendicitis, Complicated appendicitis, Gastroenteritis, Angina pectoris, Coronary artery stenosis, Pericarditis.

Data from ClinicalTrials.gov NCT02435992 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Sphingosine 1-phosphate: Lipid signaling in pathology and therapy.
Cartier A, Hla T. · · 2019 · cited 477× · PMID 31624181 · DOI 10.1126/science.aar5551
Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis.
Sandborn WJ, Feagan BG, D'Haens G, Wolf DC, et al · · 2021 · cited 411× · PMID 34587385 · DOI 10.1056/nejmoa2033617
Sphingosine 1-Phosphate Receptor Modulators and Drug Discovery.
Park SJ, Im DS. · · 2017 · cited 103× · PMID 28035084 · DOI 10.4062/biomolther.2016.160
Perspectives on Current and Novel Treatments for Inflammatory Bowel Disease.
Na SY, Moon W. · · 2019 · cited 99× · PMID 31195433 · DOI 10.5009/gnl19019
History of Inflammatory Bowel Diseases.
Actis GC, Pellicano R, Fagoonee S, Ribaldone DG. · · 2019 · cited 87× · PMID 31739460 · DOI 10.3390/jcm8111970
A State-of-the-Art Review of New and Emerging Therapies for the Treatment of IBD.
Chudy-Onwugaje KO, Christian KE, Farraye FA, Cross RK. · · 2019 · cited 87× · PMID 30445504 · DOI 10.1093/ibd/izy327
Long-Term Efficacy and Safety of Ozanimod in Moderately to Severely Active Ulcerative Colitis: Results From the Open-Label Extension of the Randomized, Phase 2 TOUCHSTONE Study.
Sandborn WJ, Feagan BG, Hanauer S, Vermeire S, et al · · 2021 · cited 80× · PMID 33438008 · DOI 10.1093/ecco-jcc/jjab012
New biologics and small molecules in inflammatory bowel disease: an update.
Sabino J, Verstockt B, Vermeire S, Ferrante M. · · 2019 · cited 73× · PMID 31205488 · DOI 10.1177/1756284819853208

Verify or expand the search:

Other trials of RPC1063

Trials testing the same drug.

NCT02797015 — Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS · Phase 1 · completed
NCT02531126 — An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis · Phase 3 · completed
NCT02576717 — A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis · Phase 3 · completed
NCT02531113 — Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease · Phase 2 · completed

Other recruiting trials for Ulcerative Colitis

Currently open trials in the same condition.

NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting

Other Celgene trials

Trials by the same sponsor.

NCT07242781 — A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult M · Phase 1 · recruiting
NCT06988488 — A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide · Phase 1, PHASE2 · recruiting
NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting
NCT06782490 — A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spastici · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02435992 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 1 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02435992.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing