Adults 18 to 70, 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.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Primary· From baseline up to safety follow-up visit on Day 99
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requi
Number of participants with at least 1 AE
Group
Value
95% CI
Placebo
4
RO7049665 3.5 mg
6
RO7049665 7.5 mg
24
Number of participants with at least one SAE
Group
Value
95% CI
Placebo
0
RO7049665 3.5 mg
0
RO7049665 7.5 mg
1
Time to Maximum Concentration (Tmax) of RO7049665Secondary· Day 1 to Day 15 (predose) and Day 43 (post-dose)
Day 1-Day 15: Dose 1
Group
Value
95% CI
RO7049665 3.5 mg
12.00
6.00 – 24.00
RO7049665 7.5 mg
24.00
6.00 – 72.08
Day 43: Dose 4
Group
Value
95% CI
RO7049665 3.5 mg
18.06
12.00 – 72.57
RO7049665 7.5 mg
24.00
12.00 – 73.17
Maximum Serum Concentration Observed (Cmax) of RO7049665Secondary· Days 1 and 43: Pre-dose, 6 h and 12 h post-dose
Day 1: Dose 1
Group
Value
95% CI
RO7049665 3.5 mg
22.5
8.59 – 63.7
RO7049665 7.5mg
47.6
13.9 – 250
Day 43: Dose 4
Group
Value
95% CI
RO7049665 3.5 mg
38.7
21.8 – 65.4
RO7049665 7.5mg
46.5
20.2 – 109
Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUCinf) of RO7049665Secondary· Days 1 and 43: Pre-dose, 6 h and 12 h post-dose
Day 1: Dose 1
Group
Value
95% CI
RO7049665 3.5 mg
2030
1020 – 3550
RO7049665 7.5 mg
4520
1780 – 15100
Day 43: Dose 4
Group
Value
95% CI
RO7049665 3.5 mg
3520
1830 – 5740
RO7049665 7.5 mg
4110
2200 – 8240
Change From Baseline in the Endoscopy Subscore of the Mayo Clinic Score (MCS-ES)Secondary· Baseline, Days 29 and 57
The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy (i.e., centrally read MCS-ES) and Physician Global Assessment (PGA). Flexible sigmoidoscopy (or colonoscopy) was centrally read and scored using the MCS-ES scoring systems. The disease was considered as endoscopic normal or inactive if the MCS-ES (centrally read) was 0, mild (erythema, decreased vascular pattern) if MCS-ES was 1, moderate (marked erythema, absent vascular pattern, erosions) if MCS-ES was 2 and severe (spontaneous bleeding, ulcera
Baseline
Group
Value
95% CI
Placebo
2.56
± 0.53
RO7049665 3.5 mg
2.44
± 0.53
RO7049665 7.5 mg
2.59
± 0.50
Change from Baseline at Day 29
Group
Value
95% CI
Placebo
-0.22
± 0.83
RO7049665 3.5 mg
-0.22
± 0.83
RO7049665 7.5 mg
-0.54
± 0.98
Change from Baseline at Day 57
Group
Value
95% CI
Placebo
-0.11
± 0.93
RO7049665 3.5 mg
0.00
± 0.53
RO7049665 7.5 mg
-0.42
± 0.72
Change From Baseline in the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)Secondary· Baseline, Days 29 and 57
Flexible sigmoidoscopy (or colonoscopy) were centrally read and scored using the UCEIS scoring systems. The UCEIS total score is a sum of 3 assessments: Bleeding (scored 0-3), Erosion and Ulcers (scored 0-3), and Vascular Pattern (scored 0-2). The total score ranges from 0-8, with higher score indicating more severe disease. A negative change from baseline indicates improvement.
Baseline
Group
Value
95% CI
Placebo
4.33
± 1.12
RO7049665 3.5 mg
4.00
± 1.73
RO7049665 7.5 mg
3.85
± 0.86
Change from Baseline at Day 29
Group
Value
95% CI
Placebo
-0.67
± 1.32
RO7049665 3.5 mg
-0.22
± 1.79
RO7049665 7.5 mg
-0.71
± 1.52
Change from Baseline at Day 57
Group
Value
95% CI
Placebo
-0.22
± 1.56
RO7049665 3.5 mg
0.63
± 1.85
RO7049665 7.5 mg
-0.71
± 1.33
Change From Baseline in Histology Score of Sigmoid Colon Biopsies Using Geboes Score (GS)Secondary· Baseline, Days 29 and 57
Mucosal biopsies were obtained during flexible sigmoidoscopy from the most affected area 10 to 20 centimeters (cm) from the anal verge. Biopsies were assessed by standard histology for changes in the inflammatory activity as measured using GS. The GS is a stepwise grading system used for the evaluation of microscopic inflammation and histopathologic disease activity in UC. The microscopic appearance of the mucosa is categorized into 6 grades: Grade 0: architectural changes, Grade 1: chronic inflammatory infiltrate, Grade 2: lamina propria neutrophils and eosinophils, Grade 3: neutrophils in ep
Baseline
Group
Value
95% CI
Placebo
4.56
± 0.88
RO7049665 3.5 mg
3.22
± 1.92
RO7049665 7.5 mg
3.54
± 2.04
Change from Baseline at Day 29
Group
Value
95% CI
Placebo
-0.33
± 1.22
RO7049665 3.5 mg
0.78
± 2.49
RO7049665 7.5 mg
-0.70
± 1.11
Change from Baseline at Day 57
Group
Value
95% CI
Placebo
-0.89
± 1.90
RO7049665 3.5 mg
0.88
± 2.85
RO7049665 7.5 mg
-0.54
± 1.82
Change From Baseline in Histology Score of Sigmoid Colon Biopsies Using Robarts Histology Index (RHI)Secondary· Baseline, Days 29 and 57
Mucosal biopsies were obtained during flexible sigmoidoscopy from the most affected area 10 to 20 cm from the anal verge. Biopsies were assessed by standard histology for changes in the inflammatory activity as measured using RIH. The RHI is an evaluative index, derived from the Geboes score and is designed to be reproducible and responsive to clinically meaningful change in disease activity over time. The total RHI score ranges from 0 (no disease activity) to 33 (severe disease activity). A negative change from baseline indicates improvement.
Baseline
Group
Value
95% CI
Placebo
18.78
± 7.19
RO7049665 3.5 mg
11.44
± 9.30
RO7049665 7.5 mg
14.88
± 10.90
Change from Baseline at Day 29
Group
Value
95% CI
Placebo
-3.11
± 8.52
RO7049665 3.5 mg
3.89
± 11.85
RO7049665 7.5 mg
-3.17
± 7.36
Change from Baseline at Day 57
Group
Value
95% CI
Placebo
-6.22
± 8.91
RO7049665 3.5 mg
5.38
± 16.83
RO7049665 7.5 mg
-1.25
± 8.90
Change From Baseline in Histology Score of Sigmoid Colon Biopsies Using Nancy Histology Index (NHI)Secondary· Baseline, Days 29 and 57
Mucosal biopsies were obtained during flexible sigmoidoscopy from the most affected area 10 to 20 cm from the anal verge. Biopsies were assessed by standard histology for changes in the inflammatory activity as measured using NHI. NHI is a validated index for assessing histological disease activity in UC. It is composed of three histological items defining five grades of disease activity: absence of significant histological disease (Grade 0), chronic inflammatory infiltrate with no acute inflammatory infiltrate (Grade 1), mildly active disease (Grade 2), moderately active disease (Grade 3), an
Baseline
Group
Value
95% CI
Placebo
3.11
± 0.78
RO7049665 3.5 mg
2.11
± 1.45
RO7049665 7.5 mg
2.42
± 1.68
Change from Baseline at Day 29
Group
Value
95% CI
Placebo
-0.56
± 1.01
RO7049665 3.5 mg
0.33
± 1.94
RO7049665 7.5 mg
-0.57
± 1.08
Change from Baseline at Day 57
Group
Value
95% CI
Placebo
-0.78
± 1.48
RO7049665 3.5 mg
0.88
± 2.42
RO7049665 7.5 mg
-0.25
± 1.29
Percentage of Participants With Mayo Clinic Score (MCS) Clinical ResponseSecondary· Baseline, Days 29 and 57
The MCS ranges from 0 to 12 and is a composite of 4 assessments: stool frequency, rectal bleeding, endoscopy (i.e., centrally read MCS-ES) and Physician Global Assessment (PGA). Each assessment was rated from 0-3, with higher score indicating more severe disease. Clinical response was defined as a decrease in the MCS of at least 3 points and at least 30% decrease from baseline.
Day 29
Group
Value
95% CI
Placebo
11.1
0.28 – 48.25
RO7049665 3.5 mg
33.3
7.49 – 70.07
RO7049665 7.5mg
16.7
4.74 – 37.38
Day 57
Group
Value
95% CI
Placebo
22.2
2.81 – 60.01
RO7049665 3.5 mg
50.0
15.7 – 84.3
RO7049665 7.5mg
45.8
25.55 – 67.18
Number of Participants With Anti-Drug Antibodies (ADAs)Secondary· Baseline; Post-dose on Days 8, 22, 57, 71 and 99; Pre-dose on Days 15, 29 and 43
ADA assays was used to detect anti-drug antibodies against RO7049665. Samples which were positive for anti-drug antibodies were further assessed using a neutralizing antibody assay. Participants were considered ADA positive if they were ADA negative at baseline but developed an ADA response following study drug administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 4-fold (treatment-enhanced ADA response).
ADA Positive: Treatment-Induced ADA Response
Group
Value
95% CI
Placebo
0
RO7049665 3.5 mg
6
RO7049665 7.5 mg
18
ADA Positive: Treatment-Enhanced ADA Response
Group
Value
95% CI
Placebo
0
RO7049665 3.5 mg
0
RO7049665 7.5 mg
2
Change From Baseline in White Blood Cells (Tregs, Teffs)Secondary· Baseline; Pre-dose: Days 15, 29 and 43; Post-dose: Days 2, 6, 8, 10, 22, 36, 48, 50, 52, 57, 71
CD4 Treg: Baseline
Group
Value
95% CI
Placebo
37.25
± 33.34
RO7049665 3.5 mg
42.14
± 25.07
RO7049665 7.5 mg
51.21
± 35.09
CD4 Treg: Change from Baseline at Day 2
Group
Value
95% CI
Placebo
-2.83
± 9.33
RO7049665 3.5 mg
-24.33
± 19.51
RO7049665 7.5 mg
-25.65
± 14.19
CD4 Treg: Change from Baseline at Day 6
Group
Value
95% CI
Placebo
12.17
± 22.53
RO7049665 3.5 mg
61.80
± 31.22
RO7049665 7.5 mg
87.37
± 66.84
CD4 Treg: Change from Baseline at Day 8
Group
Value
95% CI
Placebo
3.00
± 15.32
RO7049665 3.5 mg
66.00
± 68.26
RO7049665 7.5 mg
169.34
± 138.21
CD4 Treg: Change from Baseline at Day 10
Group
Value
95% CI
Placebo
-8.25
± 6.76
RO7049665 3.5 mg
27.20
± 18.99
RO7049665 7.5 mg
137.81
± 98.51
CD4 Treg: Change from Baseline at Day 15 (Pre-dose)
Group
Value
95% CI
Placebo
-3.80
± 11.57
RO7049665 3.5 mg
16.29
± 28.42
RO7049665 7.5 mg
37.73
± 41.74
CD4 Treg: Change from Baseline at Day 22
Group
Value
95% CI
Placebo
5.17
± 5.89
RO7049665 3.5 mg
76.00
± 70.04
RO7049665 7.5 mg
186.45
± 130.40
CD4 Treg: Change from Baseline at Day 29 (Pre-dose)
Group
Value
95% CI
Placebo
-3.75
± 6.55
RO7049665 3.5 mg
15.57
± 18.74
RO7049665 7.5 mg
27.66
± 29.09
Adverse events — posted to ClinicalTrials.gov
Time frame: From baseline up to safety follow-up visit on Day 99.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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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 Hoffmann-La Roche
Last refreshed: 15 February 2024
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/NCT03943550.