Crohn's DiseasePhase 3NCT03945019

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)

A Phase 3 study testing CT-P13 SC (Infliximab) in people with Crohn's Disease, run by Celltrion at 29 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Crohn's Disease
What is being tested?: CT-P13 SC (Infliximab)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 396 participants
Where: 29 sitesin 26 countries
Study dates: 28 Oct 2019to 22 Aug 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is male or female aged 18 to 75 years, inclusive.
Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points

Who cannot join

Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives
Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD.

Trial locations and contacts

29 sites in 26 countries.

Country

City, postcode or hospital

29 sites in 26 countries

Poland2 sites

Szpital Uniwersytecki Nr 2 im. dr Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia
Bydgoszcz
WIP Warsaw IBD Point Profesor Kierkus
Warsaw

Other trials in Poland

Russia2 sites

Klinika YZI 4D
Pyatigorsk
BioTekhServis
Saint Petersburg

Other trials in Russia

Ukraine2 sites

Communal Non-Commercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkassy
Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council
Zaporizhzhya

Other trials in Ukraine

United States1 site

Biopharma Informatic - Houston
Houston, Texas, 77084

Other trials in United States

Belarus1 site

Vitebsk Regional Clinical Hospital
Vitebsk

Other trials in Belarus

Bulgaria1 site

Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia

Other trials in Bulgaria

Croatia1 site

Clinical Hospital Centre Osijek
Osijek

Other trials in Croatia

Czechia1 site

Fakultni nemocnice Ostrava
Ostrava

Other trials in Czechia

France1 site

Centre Hospitalier Lyon Sud
Pierre-Bénite

Other trials in France

Germany1 site

Praxis Prof. Herbert Kellner
München

Other trials in Germany

Greece1 site

University General Hospital of Heraklion
Heraklion

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Hungary1 site

Debreceni Egyetem Klinikai Kozpont
Debrecen

Other trials in Hungary

India1 site

Nirmal Hospital
Surat

Other trials in India

Israel1 site

Sheba Medical Center
Ramat Gan

Other trials in Israel

Italy1 site

Fondazione Policlinico Universitario A Gemelli-Rome
Roma

Other trials in Italy

Japan1 site

Tsujinaka Hospital
Kashiwa

Other trials in Japan

Latvia1 site

Pauls Stradins Clinical University Hospital
Riga

Other trials in Latvia

Mexico1 site

BRCR Global Mexico
Guadalajara

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Moldova1 site

IMSP Institute of Clinical Cardiology
Chisinau

Other trials in Moldova

Peru1 site

Hospital Nacional Cayetano Heredia
San Martín de Porres

Other trials in Peru

Romania1 site

Dr.Carol Davila Emergency University Central Military Hospital
Bucharest

Other trials in Romania

Serbia1 site

Clinical Hospital Centar Zvezdara
Belgrade

Other trials in Serbia

Slovakia1 site

Fakultna nemocnica s poliklinikou F. D. Roosevelta
Banská Bystrica

Other trials in Slovakia

South Africa1 site

CLINRESCO, ARWYP Medical Suites
Johannesburg

Other trials in South Africa

Spain1 site

Hospital Arquitecto Marcide
Ferrol

Other trials in Spain

Turkey (Türkiye)1 site

Ege University Medical Faculty
Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease

This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease

Conditions: Crohn's Disease
Being tested: CT-P13 SC (Infliximab), Placebo SC
Medical subject headings: Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-P13 SC (Infliximab)Biological
Subcutaneous injection of CT-P13 SC
Placebo SCOther
Subcutaneous injection of Placebo SC

Study groups in NCT03945019
Study group	Role	What they receive
CT-P13 SC	Experimental	Not described Receives: Biological: CT-P13 SC (Infliximab)
Placebo SC	Placebo comparator	Not described Receives: Other: Placebo SC

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54
Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of <150 points.
The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight.
Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Measured: Week 54
Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54
Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value.
The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity.
Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.
Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level.
Measured: Week 54

Secondary outcomes (3)

Percentage of Patients Achieving CDAI-100 Response at Week 54
Crohn's Disease Activity Index (CDAI)-100 response was defined as a decrease in CDAI score of 100 points or more from the baseline value.
The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight.
Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.
Measured: Week 54
Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54
Clinical remission was defined as an average worst daily Abdominal Pain (AP) score of ≤1 (using 4-point scale) and an average daily loose/watery Stool Frequency (SF) score of ≤3 (of Type 6 or Type 7 on Bristol Stool Form Scale (BSFS)) with no worsening in either average score compared with the baseline value.
AP score is patient recorded score on a scale 0 to 3 (none, mild, moderate, or severe) and higher score indicates severe abdominal pain. SF score is patient recorded number of loose/watery stool defined as BSFS type 6 or 7 per day. BSFS is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7).
Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Measured: Week 54
Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54
Endoscopic remission was defined as an absolute Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score of ≤4 and at least 2-point reduction from the baseline value with no segment sub-score of >1.
The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity.
Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Measured: Week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 201922 Aug 2023

First posted10 May 2019
Study start28 Oct 2019
Primary completion23 Aug 2022
Study completion22 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 396 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03945019
Sponsor's protocol ID: CT-P13 3.8
Other IDs: 2019-001087-30, 2019
Status last verified: Sep 2023
First submitted: 8 May 2019
Last updated: 23 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Colombel JF, Danese S, Schreiber S, Sands BE, Yarur AJ, Kang A, Kim DH, Lee YN, Hanauer SB. Impact of Immunogenicity on Clinical Outcomes in Patients With Moderate-to-Severe Inflammatory Bowel Disease Receiving Subcutaneous Infliximab: A Post Hoc Analysis of the LIBERTY Trials. United European Gastroenterol J. 2026 Apr;14(3):e70205. doi: 10.1002/ueg2.70205.
PubMed 41986154
Schreiber S, Sands BE, Danese S, Loftus EV Jr, Jeong AL, Kim DH, Lee YN, Colombel JF. Symptom Response Dynamics for Personalised Therapy with Subcutaneous Infliximab in Crohn's Disease: Insights from the Randomised, Placebo-Controlled, Phase 3 LIBERTY-CD Trial. Adv Ther. 2026 Jun;43(6):2510-2526. doi: 10.1007/s12325-026-03533-3. Epub 2026 Mar 30.
PubMed 41910935
Dubinsky MC, Schreiber S, Yarur AJ, Sands BE, Hanauer SB, Danese S, Yu H, Kim DH, Lee YN, Colombel JF. Recovery of response and long-term outcomes following loss of response and dose escalation of subcutaneous infliximab: a post hoc analysis of the LIBERTY-CD & LIBERTY-UC trials. Inflamm Bowel Dis. 2026 Jul 1;32(7):1235-1247. doi: 10.1093/ibd/izag017.
PubMed 41849243
Colombel JF, Sandborn WJ, Schreiber S, Danese S, Klopocka M, Kierkus J, Kulynych R, Gonciarz M, Soltysiak A, Smolinski P, Sreckovic S, Valuyskikh E, Lahat A, Horynski M, Gasbarrini A, Osipenko M, Borzan V, Kowalski M, Saenko D, Sardinov R, Lee SJ, Kim S, Bae Y, Lee S, Lee S, Lee JH, Kim JM, Park G, Lee J, Lee J, Ryu JY, Sands BE, Hanauer SB. Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn's disease and ulcerative colitis: 2-year results from open-label extensions of two randomized controlled trials (LIBERTY). J Crohns Colitis. 2025 Jun 4;19(6):jjaf060. doi: 10.1093/ecco-jcc/jjaf060.
PubMed 40243842
Hanauer SB, Sands BE, Schreiber S, Danese S, Klopocka M, Kierkus J, Kulynych R, Gonciarz M, Soltysiak A, Smolinski P, Sreckovic S, Valuyskikh E, Lahat A, Horynski M, Gasbarrini A, Osipenko M, Borzan V, Kowalski M, Saenko D, Sardinov R, Lee SJ, Kim S, Bae Y, Lee S, Lee S, Lee JH, Yang S, Lee J, Lee J, Kim JM, Park G, Sandborn WJ, Colombel JF. Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY). Gastroenterology. 2024 Oct;167(5):919-933. doi: 10.1053/j.gastro.2024.05.006. Epub 2024 May 23.
PubMed 38788861

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease
ClinicalTrials.gov ID: NCT03945019
Acronym / sponsor ID: CT-P13 3.8
Conditions: Crohn's Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 396 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 28 Oct 2019 (actual)
Primary completion: 23 Aug 2022 (actual)
Study completion: 22 Aug 2023 (actual)
First posted: 10 May 2019 (actual)
Results: Posted 23 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CT-P13 SC	Experimental	Biological: CT-P13 SC (Infliximab)
Placebo SC	Placebo comparator	Other: Placebo SC

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient is male or female aged 18 to 75 years, inclusive.
Patient who has moderately to severely active CD with a score on the CDAI of 220 to 450 points

Key exclusion criteria (2 listed)

Patient who has previously received either a TNFα inhibitor or biological agent within 5 half-lives
Patient who has previously demonstrated inadequate response or intolerance to TNFα inhibitors for the treatment of CD.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-P13 SC (Infliximab)Subcutaneous injection of CT-P13 SC	Biological	CT-P13 SC
Placebo SCSubcutaneous injection of Placebo SC	Other	Placebo SC

Primary outcome

Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54
Time frame: Week 54
Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of <150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.
Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54
Time frame: Week 54
Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value. The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder. Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level.

3 secondary outcomes

Percentage of Patients Achieving CDAI-100 Response at Week 54
Time frame: Week 54
Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54
Time frame: Week 54
Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54
Time frame: Week 54

Results and safety

Results posted to the registry on 23 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT-P13 IV 5mg/kg	396	343
CT-P13 SC 120 mg	0	0
Placebo	0	0

Primary outcome: Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54

Time frame: Week 54. Count of participants. Unit: Participants

Measure	CT-P13 SC 120 mg n = 231	Placebo n = 112
Value	144	36

CT-P13 SC 120 mg vs Placebo: p <0.0001, Cochran-Mantel-Haenszel

Population analysed: All-randomized population

Primary outcome: Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54

Time frame: Week 54. Count of participants. Unit: Participants

Measure	CT-P13 SC 120 mg n = 231	Placebo n = 112
Value	118	20

CT-P13 SC 120 mg vs Placebo: p <0.0001, Cochran-Mantel-Haenszel

Population analysed: All-randomized population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT-P13 IV 5 mg/kg	12 of 396 (3%)	51 of 396 (12.9%)	0 of 396
CT-P13 SC 120 mg (Including 240 mg)	16 of 238 (6.7%)	75 of 238 (31.5%)	1 of 238
CT-P13 SC 120 mg	15 of 238 (6.3%)	70 of 238 (29.4%)	1 of 238
CT-P13 SC 120 mg to 240 mg	1 of 45 (2.2%)	9 of 45 (20%)	0 of 45
Placebo	8 of 105 (7.6%)	30 of 105 (28.6%)	0 of 105

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41986154Colombel JF, Danese S, Schreiber S, Sands BE, Yarur AJ, Kang A, Kim DH, Lee YN, Hanauer SB. Impact of Immunogenicity on Clinical Outcomes in Patients With Moderate-to-Severe Inflammatory Bowel Disease Receiving Subcutaneous Infliximab: A Post Hoc Analysis of the LIBERTY Trials. United European Gastroenterol J. 2026 Apr;14(3):e70205. doi: 10.1002/ueg2.70205.
Derived from this study: PubMed 41910935Schreiber S, Sands BE, Danese S, Loftus EV Jr, Jeong AL, Kim DH, Lee YN, Colombel JF. Symptom Response Dynamics for Personalised Therapy with Subcutaneous Infliximab in Crohn's Disease: Insights from the Randomised, Placebo-Controlled, Phase 3 LIBERTY-CD Trial. Adv Ther. 2026 Jun;43(6):2510-2526. doi: 10.1007/s12325-026-03533-3. Epub 2026 Mar 30.
Derived from this study: PubMed 41849243Dubinsky MC, Schreiber S, Yarur AJ, Sands BE, Hanauer SB, Danese S, Yu H, Kim DH, Lee YN, Colombel JF. Recovery of response and long-term outcomes following loss of response and dose escalation of subcutaneous infliximab: a post hoc analysis of the LIBERTY-CD & LIBERTY-UC trials. Inflamm Bowel Dis. 2026 Jul 1;32(7):1235-1247. doi: 10.1093/ibd/izag017.
Derived from this study: PubMed 40243842Colombel JF, Sandborn WJ, Schreiber S, Danese S, Klopocka M, Kierkus J, Kulynych R, Gonciarz M, Soltysiak A, Smolinski P, Sreckovic S, Valuyskikh E, Lahat A, Horynski M, Gasbarrini A, Osipenko M, Borzan V, Kowalski M, Saenko D, Sardinov R, Lee SJ, Kim S, Bae Y, Lee S, Lee S, Lee JH, Kim JM, Park G, Lee J, Lee J, Ryu JY, Sands BE, Hanauer SB. Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn's disease and ulcerative colitis: 2-year results from open-label extensions of two randomized controlled trials (LIBERTY). J Crohns Colitis. 2025 Jun 4;19(6):jjaf060. doi: 10.1093/ecco-jcc/jjaf060.
Derived from this study: PubMed 38788861Hanauer SB, Sands BE, Schreiber S, Danese S, Klopocka M, Kierkus J, Kulynych R, Gonciarz M, Soltysiak A, Smolinski P, Sreckovic S, Valuyskikh E, Lahat A, Horynski M, Gasbarrini A, Osipenko M, Borzan V, Kowalski M, Saenko D, Sardinov R, Lee SJ, Kim S, Bae Y, Lee S, Lee S, Lee JH, Yang S, Lee J, Lee J, Kim JM, Park G, Sandborn WJ, Colombel JF. Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY). Gastroenterology. 2024 Oct;167(5):919-933. doi: 10.1053/j.gastro.2024.05.006. Epub 2024 May 23.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

29 sites in 26 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CT-P13 SC (Infliximab) in people with Crohn's Disease, run by Celltrion at 29 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Poland, Russia, Ukraine, United States, Belarus and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54 (time frame: Week 54). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03945019, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.