CDAI remission is defined as

- CDAI score < 150

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 1 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.

Endoscopic response is defined as

- Minimum of 50% decrease from Baseline in SES-CD total score

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 2 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 26.

Clinical Remission is defined as

- Average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 3 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 25.

CDAI response is defined as

- CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 4 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.

CDAI remission at both Week 12 and Week 52 is defined as

- CDAI score < 150 at both Week 12 and 52

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 5 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.

CDAI response at both Week 12 and Week 52 is defined as

- CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points at both Week 12 and 52

Outcome measure 6 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.

Endoscopic response at both Week 12 and Week 52 is defined as

- Minimum of 50% decrease from Baseline in SES-CD total score at both Week 12 and 52

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 7 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 26.

Clinical remission at both Week 12 and Week 52 is defined as

- Average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item at both Week 12 and 52

Outcome measure 8 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.

Endoscopic remission is defined as

- SES-CD total score of 0-2, OR SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore > 1

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 9 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 26.

Clinical remission is defined as

- Average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 10 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.

CDAI response is defined as

- CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 11 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.

CDAI remission is defined as

- CDAI score < 150

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 12 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the CDAI score which is provided in ad hoc outcome measure 25.

Endoscopic response is defined as

- Minimum of 50% decrease from Baseline in SES-CD total score

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 13 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 26.

SES-CD total score of 0 - 2 is defined as

- SES-CD total score of 0 - 2

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 14 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 26.

Endoscopic response and endoscopic remission is defined as

• Endoscopic response at Week 12 and
• endoscopic remission at Week 52

Further, if the patient

• discontinue treatment prematurely for any reason
• takes rescue treatment or meet the rescue criteria
• uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder

Outcome measure 15 is not available since the component based on rescue and prohibited medication is defined by adjudication of blinded data. The adjudication was not performed, and the adjudicated data is not available. Thus, this outcome measure cannot be derived due to lack of this component. What can be derived is descriptive statistics for the SES-CD score which is provided in ad hoc outcome measure 26.

serum concentration of brazikumab

The PK population includes all participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations.

Immunogenicity: incidence of brazikumab anti-drug antibodies in serum

The data is reported for the PK population including all participants who receive at least 1 dose of study intervention and have at least 1 PK sample containing detectable brazikumab concentrations.

Derive exposure-response model linking primary endpoint to metrics of model predicted individual brazikumab exposures.

Since the primary endpoint (outcome measure 1) cannot be reported due to the lack of the component based on rescue and prohibited medication, which is defined by adjudication of blinded data, the data for the exposure-response analysis is not available.

Derive the relationship between baseline serum IL-22 concentration and efficacy of brazikumab through CDAI remission and endoscopic response.

Since the serum IL-22 concentration clinical cut-off is derived based on the CDAI remission (outcome measure1) and endoscopic response (outcome measure 2), which cannot be reported due to the lack of the component based on rescue and prohibited medication, defined by adjudication of blinded data, the data for the serum IL-22 concentration clinical cut-off is not available.

Number and percentage of patients with reported Adverse Events

The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.

Number and percentage of participants with Potentially Clinically Significant Postbaseline results in hematology, clinical chemistry, and urinalysis.

The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.

Number and percentage of participants with Potentially Clinically Significant Postbaseline results in systolic, diastolic pulse rate.

The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.

Physical examination as safety assessment, to facilitate the evaluation of the safety objective (Adverse Events).

Any new or aggravated clinically relevant abnormal medical finding occurring at a physical examination (PE) as compared with the Baseline assessment was considered as a treatment emergent adverse event and is reported in the Adverse Event section. No data related to the PE was captured and it was not captured for the adverse events if it was related to a PE. Since it was never collected it is not possible to report either any PE data or the AEs related to a PE separately.

Number and percentage of participants with Potentially Clinically Significant Postbaseline results in 12-lead ECG recordings.

The Analysis Population is the Safety Analysis Set, consisting of all participants who received at least one dose of study intervention in the study.

Mean CDAI score at Baseline, Week 12, and Change from Baseline

Since the pre-specified outcome measure based on the CDAI score cannot be reported due to the lack of the component based on rescue and prohibited medication, which is defined by adjudication of blinded data, the CDAI score is reported since that is the data assessed and available.

SES-CD component and total scores at Baseline and Week 12

Since the pre-specified outcome measure based on the SES-CD score cannot be reported due to the lack of the component based on rescue and prohibited medication, which is defined by adjudication of blinded data, the SES-CD score is reported since that is the data assessed and available.