Trial Outcomes & Findings for An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease (NCT NCT01536418)

Last Updated: 2018-01-29

Results Overview

Clinical response, defined as decrease in Crohn's disease activity index (CDAI) score, from Baseline value of \>=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of \>=220 to \<=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using "no effect" imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, \< 100,participant was considered non-responder.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

255 participants

Primary outcome timeframe

At Week 12

Results posted on

2018-01-29

Participant Flow

A total of 253 participants, having moderate-to-severe Active Crohn's Disease were randomized to the study. The study was conducted from 11 November 2011 to 17 October 2013, at 113 centers in 26 countries with sites in North America, Europe, Israel, Japan, Republic of Korea, Hong Kong, Taiwan, Australia and New Zealand.

Participant milestones

Participant milestones
Measure	GSK1605786A, 500 Milligram (mg), Once Daily Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.	GSK1605786A, 500 mg Twice Daily Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
Overall Study STARTED	127	126
Overall Study COMPLETED	58	60
Overall Study NOT COMPLETED	69	66

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1605786A, 500 Milligram (mg), Once Daily Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.	GSK1605786A, 500 mg Twice Daily Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
Overall Study Protocol Violation	2	3
Overall Study Physician Decision	1	3
Overall Study Study closed/terminated	41	37
Overall Study Lack of Efficacy	10	16
Overall Study Adverse Event	9	4
Overall Study Met Liver Chemistry Stopping criteria	1	0
Overall Study Withdrawal by Subject	5	3

Baseline Characteristics

An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1605786A 500 mg, Once Daily n=127 Participants Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.	GSK1605786A 500 mg, Twice Daily n=126 Participants Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.	Total n=253 Participants Total of all reporting groups
Age, Continuous	39.6 Years STANDARD_DEVIATION 13.11 • n=5 Participants	38.5 Years STANDARD_DEVIATION 12.91 • n=7 Participants	39.1 Years STANDARD_DEVIATION 13.00 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	64 Participants n=7 Participants	127 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	62 Participants n=7 Participants	126 Participants n=5 Participants
Race/Ethnicity, Customized White-Caucasian/European	105 participants n=5 Participants	109 participants n=7 Participants	214 participants n=5 Participants
Race/Ethnicity, Customized White-Arabic/North African	104 participants n=5 Participants	105 participants n=7 Participants	209 participants n=5 Participants
Race/Ethnicity, Customized Black	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Asian-East	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants
Race/Ethnicity, Customized Asian-South East	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Asian-Japanese	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Multiple race	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 12

Population: The Intent-to-Treat (ITT) population comprised of all participants who have satisfied the eligibility criteria and were assigned with study medication.

Outcome measures

Outcome measures
Measure	GSK1605786A 500 mg, Once Daily n=127 Participants Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.	GSK1605786A 500 mg,Twice Daily n=126 Participants Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
Percentage of Participants Achieving Clinical Response at Week 12	25.2 Percentage of participants	33.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 8 and Week 12

Population: ITT population

Clinical remission is defined as a CDAI score of \<150 points. CDAI is scoring system measuring disease severity with scores of \>=220 to \<=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using "no effect" imputation where missing was no response or no change in response (were non-responders). If the Baseline value was \<150, the participant was not considered to have achieved remission.

Outcome measures

Outcome measures
Measure	GSK1605786A 500 mg, Once Daily n=127 Participants Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.	GSK1605786A 500 mg,Twice Daily n=126 Participants Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
Percentage of Participants Achieving Clinical Remission at Week 8, Week 12 and at Both Week 8 and Week 12 Week 8	11.8 Percentage of participants	14.3 Percentage of participants
Percentage of Participants Achieving Clinical Remission at Week 8, Week 12 and at Both Week 8 and Week 12 Week 12	11.8 Percentage of participants	17.5 Percentage of participants
Percentage of Participants Achieving Clinical Remission at Week 8, Week 12 and at Both Week 8 and Week 12 Both Week 8 and Week 12	7.9 Percentage of participants	10.3 Percentage of participants

SECONDARY outcome

Timeframe: Both Week 8 and Week 12

Population: ITT population

Outcome measures

Outcome measures
Measure	GSK1605786A 500 mg, Once Daily n=127 Participants Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.	GSK1605786A 500 mg,Twice Daily n=126 Participants Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
Percentage of Participants With a Clinical Response at Week 8 and at Both Week 8 and Week 12 Week 8	24.4 Percentage of participants	29.4 Percentage of participants
Percentage of Participants With a Clinical Response at Week 8 and at Both Week 8 and Week 12 Both Week 8 and Week 12	15.7 Percentage of participants	24.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Screening) and Weeks 4, 8, and Week 12

Population: ITT Population.

Blood samples were planned to be collected for the measurement of C-reactive protein at Baseline (Screening) and at Weeks 4, 8, and 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time points (Week 4, week 8 and week 12) minus the value at Baseline respectively. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Screening) and Week 12

Population: ITT Population.

Stool samples were planned to be collected for the measurement faecal calprotectin level at Baseline (Screening) and Week 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Screening) and Week 12

Population: The PK population consisted of the participants having received investigational product (i.e., participants in the Safety population) and for whom a sample was obtained and analyzed.

The PK analyses was planned to perform to characterize the PK of the study drug GSK1605786A, in the participant population. PK is defined as the concentration of drug in a participant's blood at certain time points after the drug was taken by mouth. PK sampling was to be conducted at week 2, 4, 6 ,8, 10 and week 12 (pre-dose, post-dose 0.5 hour (hr) to 2 hr, 3 to 6 hr, and 6 to 28 hr post-dose. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus the data for this outcome measure was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post randomization any time during early two weeks

Population: ITT population.

Sample for the pharmacogenetic analyses was collected during any one of the Treatment Phase visit (Week 2, 4, 6, or 8 ). The pharmacogenetic analyses was planned to perform to investigate the relationship between the genetic markers with the safety and efficacy response to GSK1605786A. These pharmacogenetic analyses was not conducted following the early termination of the study. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

GSK1605786A 500 mg, Once Daily

Serious events: 8 serious events

Other events: 61 other events

Deaths: 0 deaths

GSK1605786A 500 mg, Twice Daily

Serious events: 6 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK1605786A 500 mg, Once Daily n=127 participants at risk Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.	GSK1605786A 500 mg, Twice Daily n=126 participants at risk Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
Infections and infestations Anal abscess	0.79% 1/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.00% 0/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Infections and infestations Bronchitis	0.00% 0/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.79% 1/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Infections and infestations Cellulitis	0.00% 0/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.79% 1/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Infections and infestations Tonsillitis	0.00% 0/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.79% 1/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Cardiac disorders Acute myocardial infarction	0.79% 1/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.00% 0/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Cardiac disorders Atrial fibrillation	0.79% 1/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.00% 0/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Cardiac disorders Cardiac failure	0.00% 0/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.79% 1/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Gastrointestinal disorders Crohn's disease	0.79% 1/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.79% 1/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Gastrointestinal disorders Oesophageal ulcer	0.79% 1/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.00% 0/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.79% 1/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.79% 1/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Blood and lymphatic system disorders Anaemia	0.79% 1/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.00% 0/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Investigations Hepatic enzyme increased	0.79% 1/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.00% 0/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.79% 1/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	0.00% 0/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment

Other adverse events

Other adverse events
Measure	GSK1605786A 500 mg, Once Daily n=127 participants at risk Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.	GSK1605786A 500 mg, Twice Daily n=126 participants at risk Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
Gastrointestinal disorders Abdominal pain	10.2% 13/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	9.5% 12/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Gastrointestinal disorders Dyspepsia	4.7% 6/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	7.9% 10/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Gastrointestinal disorders Crohn's disease	5.5% 7/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	6.3% 8/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Gastrointestinal disorders Nausea	7.1% 9/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	4.0% 5/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Infections and infestations Nasopharyngitis	6.3% 8/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	4.0% 5/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
Nervous system disorders Headache	7.9% 10/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	11.1% 14/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment
General disorders Pyrexia	6.3% 8/127 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment	2.4% 3/126 • Adverse events (AEs) and serious adverse events (SAEs) were collected from start of study treatment (Week 0) and until week 16 for participants not entering the maintenance study CCX114157, on completion of Week 12, or until final follow-up contact. SAEs and non-serious AEs were collected in participants of the Safety Population, comprised of all participants in the ITT population except those who did not received at least one dose of treatment

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER