Crohn's DiseasePhase 2NCT02405442
Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
A Phase 2 study testing Andecaliximab in people with Crohn's Disease, run by Gilead Sciences at 74 sites in 13 countries.
Trial summary
This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. 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?
- Andecaliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 74 sitesin 13 countries
- Study dates
- 30 Apr 2015to 22 Dec 2016
- Phase
- Phase 2
- 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
- Ability to provide a written informed consent
- Females of childbearing potential must have a negative pregnancy test at screening and baseline
- Documented diagnosis of Crohn's disease with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum
- Moderately to severely active Crohn's disease as defined by a Crohn's Disease Activity Index (CDAI) total score between 220-450 (inclusive) AND with evidence of active disease as measured by ileocolonoscopy
- Within the previous 5 years, demonstrated an inadequate clinical response or intolerance of at least one of the following agents:
- Corticosteroids
Show all 16Show fewer
- Immunomodulators
- Tumor necrosis factor-alpha (TNFα) antagonists
- Vedolizumab
- May be receiving the following drugs:
- Oral 5-aminosalicylate (5-ASA)
- Oral corticosteroid therapy
- Antidiarrheals for chronic diarrhea
- Azathioprine or 6-mercaptopurine (6-MP) or methotrexate
- Antibiotics for the treatment of Crohn's disease
- Able to comply with the dosing instructions for study drug and able to comply with the study visits and requirements
Who cannot join
- Evidence of abscess at screening
- Extensive colonic resection (subtotal or total colectomy) or history of > 2 small bowel resections
- Ileostomy, colostomy, or symptomatic stenosis of the intestine
- Current use of oral corticosteroids at a dose equivalent to > 30 mg/day of prednisone
- Ulcerative colitis or indeterminate colitis
- Short bowel syndrome
Show all 13Show fewer
- Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
- Treatment with any monoclonal antibody within 4 weeks of screening
- History or evidence of colonic mucosal dysplasia
- HIV, hepatitis B, hepatitis C, or tuberculosis (TB) infection
- Participated in a clinical study with an investigational drug or biologic within the last 30 days
- Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
74 sites in 13 countries.
74 sites in 13 countries
United States33 sites
University of Michigan
Ann Arbor, Michigan
Texas Clinical Research Institute
Arlington, Texas
Asheville Gastroenterology Associates
Asheville, North Carolina
Gastroenterology Associates Of Tidewater
Chesapeake, Virginia
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan
Consultants For Clinical Research
Cincinnati, Ohio
Iowa Digestive Disease Center
Clive, Iowa
Digestive Health Specialists of The Southeast
Dothan, Alabama
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey
Gastro One
Germantown, Tennessee
Ertan Digestive Disease Center of Excellence, UTH/MH-TMC
Houston, Texas
Medical Diagnostic Center (MDC)-Indiana University (IU) Health University Hospital
Indianapolis, Indiana
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire
South Denver Gastroenterology
Lone Tree, Colorado
Cedars Sinai Medical Center
Los Angeles, California
Gastroenterology Associates Of Central Georgia, LLC
Macon, Georgia
Great Lakes Gastroenterology
Mentor, Ohio
University of Miami
Miami, Florida
Delta Research Partners
Monroe, Louisiana
Gastroenterology Group Of Naples
Naples, Florida
Vanderbilt University Medical Center
Nashville, Tennessee
Columbia University Medical Center/ New York Presbyterian
New York, New York
Digestive and Liver Disease Specialists
Norfolk, Virginia
Premier Medical Group Of The Hudson Valley
Poughkeepsie, New York
Mcguire Dvamc
Richmond, Virginia
Mayo Clinic Rochester
Rochester, Minnesota
Mayo Clinic Rochester
Rochester, New York
Gastroenterology Research of San Antonio
San Antonio, Texas
Mayo Clinic
Scottsdale, Arizona
University of Washington Medical Center
Seattle, Washington
Louisiana Research Center
Shreveport, Louisiana
Washington University School of Medicine
St Louis, Missouri
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas
Poland7 sites
The Medical University of Bialystok Clinical
Bialystok
Gastromed
Lublin
Ai Centrum Medyczne
Poznan
CRC Sp. z o.o.
Poznan
Endoskopia SP. z.o.o.
Sopot
Centralny Szpital Kliniczny MSWiA
Warsaw
Lexmedica
Wroclaw
Australia5 sites
Royal Adelaide Hospital
Adelaide, South Australia
Flinders Medical Centre
Bedford Park, South Australia
Concord Repatriation General Hospital
Concord, New South Wales
Footscray Hospital
Footscray, Victoria
Gastroenterology/Colorectal Medicine & Genetics
Melbourne, Victoria
France4 sites
Hopital Beaujon
Clichy
CHRU de Lille
Lille
Chu Hotel Dieu-Chu De Nantes
Nantes
CHU de Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez
Hungary4 sites
Rethy Pal Hospital-Clinic Bekescsaba
Békéscsaba
Tolna Megye Balassa Janos Korhaz
Beri Balogh Adam
Pannonia Maganorvosi Centrum Kft
Budapest
Debreceni Egyeterm Orvos es Egeszsegtudomanyi Centrum
Debrecen
Spain4 sites
Hospital Universitari de Bellvitge
Barcelona
Hospital Universitario de Fuenlabrada
Fuenlabrada
Hospital Ramon y Cajal
Madrid
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
Germany3 sites
Universitatsklinikum Schleswig-Holstein
Kiel
Eugastro Gmbh
Leipzig
Klinikum der Universitat Munchen
München
New Zealand3 sites
Christchurch Hospital
Christchurch
Southern District Health Board
Dunedin
Capital and Coast District Health board-Wellington hospital
Wellington
United Kingdom3 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge
Norfolk and Norwich University Hospital Nhs Foundation Trust
Norwich, Norfolk
Oxford University Hospitals NHS Trust
Oxford
Canada2 sites
Percuro Clinical Research Ltd.
Victoria, British Columbia
Percuro Clinical Research Ltd.
Victoria
Czechia2 sites
Hepato-Gastroenterologie Hk S.R.O.
Hradec Králové
Ibd Clinical And Research Centre-Iscare Ivf
Prague
Italy2 sites
Universita Campus Biomedico
Roma
Humanitas Research Hospital
Rozzano
South Africa2 sites
Parklands Medical Centre
Durban
Panorama Mediclinic Pvt Hospital
Panorama, Cape Town
About this study
Official title: A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease
This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.
- Conditions
- Crohn's Disease
- Being tested
- Andecaliximab, Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndecaliximabDrug
Also called GS-5745
Andecaliximab administered via subcutaneous (SC) injection
PlaceboDrug
Placebo to match andecaliximab administered via SC injection
| Study group | Role | What they receive |
|---|---|---|
| Andecaliximab 150 mg Every 2 Weeks | Experimental | Double-Blind Phase: Participants will receive 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5, and 7. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks. Receives: Drug: Andecaliximab; Drug: Placebo |
| Andecaliximab 150 mg Weekly | Experimental | Double-Blind Phase: Participants will receive 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks. Receives: Drug: Andecaliximab; Drug: Placebo |
| Andecaliximab 300 mg Weekly | Experimental | Double-Blind Phase: Participants will receive 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks. Receives: Drug: Andecaliximab |
| Placebo | Placebo comparator | Double-Blind Phase: Participants will receive 2 single-use PFS of placebo coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks. Receives: Drug: Andecaliximab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Clinical Response (PRO2 Score ≤ 8) at Week 8 of the Double-Blind Phase
Clinical response was defined as patient-reported outcomes (PRO2) score ≤ 8 at Week 8. PRO2 is the weighted average of the 2 variables of frequency of liquid or very soft stool and abdominal pain, based on 7-day participant diary data. The PRO2 score has a minimum score of 0 and has no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with a missing PRO2 value at the Week 8 analysis visit were imputed as not achieving the Clinical Response.
Measured: Week 8
Percentage of Participants Achieving Endoscopic Response (≥ 50% Reduction From Baseline SES-CD) at Week 8 of the Double-Blind Phase
Endoscopic response was defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 8. The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD value at Week 8 analysis visit were imputed as not achieving Endoscopic Response.
Measured: Week 8
Secondary outcomes (2)
Percentage of Participants Achieving CDAI Remission (CDAI ≤ 150) at Week 8 of the Double-Blind Phase
Clinical remission was defined as Crohn's Disease Activity Index (CDAI) ≤ 150 at Week 8. CDAI is used as a measure of clinical response and remission. It includes 8 variables of patient-reported symptoms and objective variables: stool count, abdominal pain, general well-being, complications, use of anti-diarrheal medications, presence of abdominal mass, hematocrit values, and weight. It has a minimum range of 0 and no upper bound, with higher scores indicating greater disease activity. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing CDAI score at Week 8 analysis visit were imputed as not achieving CDAI Remission.
Measured: Week 8
Percentage of Participants Achieving Mucosal Healing (SES-CD Size-of-Ulcer Subscore = 0) at Week 8 of the Double-Blind Phase
The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The SES-CD size-of-ulcer subscore ranges from 0 (none) to 3 (very large). Mucosal healing at Week 8 was defined as the size-of-ulcer subscore for segments with non-zero baseline value changes to zero at Week 8 AND the size-of-ulcer subscore for segments with zero value at baseline remain zero at Week 8. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD size-of-ulcer subscore at Week 8 analysis visit were imputed as not achieving Mucosal Healing.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study start30 Apr 2015
- Primary completion30 Nov 2016
- Study completion22 Dec 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Team, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405442
- Sponsor's protocol ID
- GS-US-395-1663
- Other IDs
- 2015-001249-10, 2015
- Status last verified
- Apr 2019
- First submitted
- 27 Mar 2015
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Schreiber S, Siegel CA, Friedenberg KA, Younes ZH, Seidler U, Bhandari BR, Wang K, Wendt E, McKevitt M, Zhao S, Sundy JS, Lee SD, Loftus EV. A Phase 2, Randomized, Placebo-Controlled Study Evaluating Matrix Metalloproteinase-9 Inhibitor, Andecaliximab, in Patients With Moderately to Severely Active Crohn's Disease. J Crohns Colitis. 2018 Aug 29;12(9):1014-1020. doi: 10.1093/ecco-jcc/jjy070.
PubMed 29846530
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT02405442
- Acronym / sponsor ID
- GS-US-395-1663
- Conditions
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Posted 28 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Andecaliximab 150 mg Every 2 Weeks | Experimental | Drug: Andecaliximab, Drug: PlaceboDouble-Blind Phase: Participants will receive 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5, and 7. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks. |
| Andecaliximab 150 mg Weekly | Experimental | Drug: Andecaliximab, Drug: PlaceboDouble-Blind Phase: Participants will receive 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks. |
| Andecaliximab 300 mg Weekly | Experimental | Drug: AndecaliximabDouble-Blind Phase: Participants will receive 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks. |
| Placebo | Placebo comparator | Drug: Andecaliximab, Drug: PlaceboDouble-Blind Phase: Participants will receive 2 single-use PFS of placebo coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Ability to provide a written informed consent
- Females of childbearing potential must have a negative pregnancy test at screening and baseline
- Documented diagnosis of Crohn's disease with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum
- Moderately to severely active Crohn's disease as defined by a Crohn's Disease Activity Index (CDAI) total score between 220-450 (inclusive) AND with evidence of active disease as measured by ileocolonoscopy
- Within the previous 5 years, demonstrated an inadequate clinical response or intolerance of at least one of the following agents:
Key exclusion criteria (13 listed)
- Evidence of abscess at screening
- Extensive colonic resection (subtotal or total colectomy) or history of > 2 small bowel resections
- Ileostomy, colostomy, or symptomatic stenosis of the intestine
- Current use of oral corticosteroids at a dose equivalent to > 30 mg/day of prednisone
- Ulcerative colitis or indeterminate colitis
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 |
|---|---|---|
| AndecaliximabAlso: GS-5745Andecaliximab administered via subcutaneous (SC) injection | Drug | Andecaliximab 150 mg Every 2 Weeks, Andecaliximab 150 mg Weekly, Andecaliximab 300 mg Weekly, Placebo |
| PlaceboPlacebo to match andecaliximab administered via SC injection | Drug | Andecaliximab 150 mg Every 2 Weeks, Andecaliximab 150 mg Weekly, Placebo |
Primary outcome
Percentage of Participants Achieving Clinical Response (PRO2 Score ≤ 8) at Week 8 of the Double-Blind Phase
Time frame: Week 8
Clinical response was defined as patient-reported outcomes (PRO2) score ≤ 8 at Week 8. PRO2 is the weighted average of the 2 variables of frequency of liquid or very soft stool and abdominal pain, based on 7-day participant diary data. The PRO2 score has a minimum score of 0 and has no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with a missing PRO2 value at the Week 8 analysis visit were imputed as not achieving the Clinical Response.
Percentage of Participants Achieving Endoscopic Response (≥ 50% Reduction From Baseline SES-CD) at Week 8 of the Double-Blind Phase
Time frame: Week 8
Endoscopic response was defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 8. The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD value at Week 8 analysis visit were imputed as not achieving Endoscopic Response.
2 secondary outcomes
Percentage of Participants Achieving CDAI Remission (CDAI ≤ 150) at Week 8 of the Double-Blind Phase
Time frame: Week 8
Percentage of Participants Achieving Mucosal Healing (SES-CD Size-of-Ulcer Subscore = 0) at Week 8 of the Double-Blind Phase
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29846530Schreiber S, Siegel CA, Friedenberg KA, Younes ZH, Seidler U, Bhandari BR, Wang K, Wendt E, McKevitt M, Zhao S, Sundy JS, Lee SD, Loftus EV. A Phase 2, Randomized, Placebo-Controlled Study Evaluating Matrix Metalloproteinase-9 Inhibitor, Andecaliximab, in Patients With Moderately to Severely Active Crohn's Disease. J Crohns Colitis. 2018 Aug 29;12(9):1014-1020. doi: 10.1093/ecco-jcc/jjy070.
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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.
Gilead Study Team study director
Gilead Sciences
74 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Andecaliximab in people with Crohn's Disease, run by Gilead Sciences at 74 sites in 13 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 16 inclusion and 13 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: stopped early, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Poland, Australia, France, Hungary and 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Mar 2019). 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 Participants Achieving Clinical Response (PRO2 Score ≤ 8) at Week 8 of the Double-Blind Phase (time frame: Week 8). 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 NCT02405442, which also lists 1 linked publication.
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 Apr 2019.