Colorectal CancerPhase 1NCT03798626
Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers
A Phase 1 study testing Gevokizumab, Bevacizumab and Modified FOLFOX6 in people with Colorectal Cancer and Gastroesophageal Cancer, run by Novartis Pharmaceuticals at 34 sites in 15 countries.
Trial summary
This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma, and the preliminary… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colorectal Cancer, Gastroesophageal Cancer, Renal Cell Carcinoma
- What is being tested?
- Gevokizumab, Bevacizumab and Modified FOLFOX6
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 34 sitesin 15 countries
- Study dates
- 22 May 2019to 5 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For All Cohorts:
- Adult ≥ 18 years old.
- Metastatic disease not amenable to potentially curative surgery and with available archival tumor tissue or fresh tumor tissue biopsy.
- Presence of at least 1 measurable lesion assessed by CT and/or MRI according to RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Adequate bone marrow and organ function per defined criteria in the protocol.
Show all 20Show fewer
- Recovered from acute laboratory and clinical toxicities of prior anti cancer treatment to NCI CTCAE v5.0 grade ≤1 at time of screening, except alopecia and amenorrhea.
- For Cohort A:
- First line metastatic colorectal adenocarcinoma.
- For Cohort B:
- Second line metastatic colorectal adenocarcinoma that has progressed on prior line of chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin.
- For Cohort C:
- Second line metastatic gastroesophageal adenocarcinoma that has progressed on prior line of chemotherapy administered for metastatic disease, and which must include a platinum agent and fluoropyrimidine doublet.
- For Cohort D:
- Second or third line metastatic renal cell carcinoma with a clear cell component and has received one or two lines of treatment for metastatic disease that included an anti angiogenic agent for at least 4 weeks with radiologic progression on that treatment.
- For subjects starting from Part 1a in Cohorts A and B:
- Serum hs CRP at screening ≥ 10 mg/L (per central laboratory assessment).
- Not requiring immediate initiation of anti cancer therapy per investigator's best judgement.
- For subjects starting from Part 2 in Cohort C:
- Serum hs CRP at screening ≥ 10 mg/L (per central laboratory assessment).
Who cannot join
- For All Cohorts:
- Currently receiving any of the prohibited medications or has contraindications as outlined in the 'Contraindications' to SOC regimen components.
- Symptomatic brain metastases or brain metastases that require directed therapy (such as focal radiotherapy or surgery).
- Suspected or proven immunocompromised state, or infections (as defined in the protocol).
- Conditions that have a high risk of clinically significant bleeding after administration of anti VEGF agents.
- Clinically significant, uncontrolled or recent (within last 6 months) cardiovascular disease.
Show all 10Show fewer
- For Cohort D:
- Concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5, and medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
- Impairment of GI function or GI disease that may significantly alter the absorption of cabozantinib.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
34 sites in 15 countries.
34 sites in 15 countries
Spain6 sites
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Madrid, 28050
Novartis Investigative Site
Seville, 41013
Novartis Investigative Site
Valencia, 46010
Japan5 sites
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8603
Novartis Investigative Site
Kashiwa, Chiba, 2778577
Novartis Investigative Site
Nagoya, Aichi-ken, 464 8681
Novartis Investigative Site
Osaka, Osaka, 5418567
Novartis Investigative Site
Sunto Gun, Shizuoka, 411 8777
United States3 sites
University of California LA
Los Angeles, California, 90095
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
WA Uni School Of Med
St Louis, Missouri, 63110
Belgium3 sites
Novartis Investigative Site
Brussels, 1000
Novartis Investigative Site
Edegem, 2650
Novartis Investigative Site
Leuven, 3000
Germany3 sites
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Frankfurt am Main, Hesse, 60488
Novartis Investigative Site
Ulm, 89081
Canada2 sites
Novartis Investigative Site
Calgary, Alberta, T2N4N2
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Israel2 sites
Novartis Investigative Site
Ramat Gan, 5265601
Novartis Investigative Site
Tel Aviv, 6423906
Italy2 sites
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Rozzano, MI, 20089
United Kingdom2 sites
Novartis Investigative Site
London, SW3 6JJ
Novartis Investigative Site
Manchester, M20 2BX
Chile1 site
Novartis Investigative Site
Santiago, Santiago Metropolitan, 8330074
About this study
Official title: Phase Ib Study of Gevokizumab in Combination With Standard of Care Anti-cancer Therapies in Patients With Metastatic Colorectal Cancer, Gastroesophageal Cancer and Renal Cell Carcinoma
This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma, and the preliminary efficacy of gevokizumab in combination with the SOC anti-cancer therapy in subjects with mCRC and mGEC.
- Being tested
- Gevokizumab, Bevacizumab, Modified FOLFOX6, FOLFIRI, Ramucirumab
- Keywords
- colorectal cancer, gastroesophageal cancer, renal cell carcinoma, gevokizumab, bevacizumab, modified FOLFOX6, FOLFIRI, ramucirumab, paclitaxel, cabozantinib, CRC, GEC, RCC, VPM087
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GevokizumabDrug
Also called VPM087
60 mg/mL concentration; administered intravenously (IV)
BevacizumabDrug
25 mg/mL concentration; administered IV
Modified FOLFOX6Drug
Also called oxaliplatin, leucovorin, 5-fluorouracil
Oxaliplatin [5 mg/mL concentration; administered IV], leucovorin [10 mg/mL concentration; administered IV] (or levoleucovorin [10 mg/mL concentration; administered IV]), and 5-fluorouracil [50 mg/mL concentration; administered IV]
FOLFIRIDrug
Also called irinotecan, leucovorin, 5-fluorouracil
Irinotecan [20 mg/mL concentration; administered IV], leucovorin [10 mg/mL concentration; administered IV] (or levoleucovorin [10 mg/mL concentration; administered IV]), and 5-fluorouracil [50 mg/mL concentration; administered IV]
RamucirumabDrug
10 mg/mL concentration; administered IV
PaclitaxelDrug
6 mg/mL concentration; administered IV
CabozantinibDrug
60 mg tablet; administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: 1st line colorectal cancer | Experimental | Treatment for 1st line metastatic colorectal cancer (mCRC) with Gevokizumab, modified FOLFOX6, bevacizumab Receives: Drug: Gevokizumab; Drug: Bevacizumab; Drug: Modified FOLFOX6 |
| Cohort B: 2nd line colorectal cancer | Experimental | Treatment for 2nd line mCRC with Gevokizumab, FOLFIRI, bevacizumab Receives: Drug: Gevokizumab; Drug: Bevacizumab; Drug: FOLFIRI |
| Cohort C: 2nd line gastroesophageal cancer | Experimental | Treatment for 2nd line metastatic gastroesophageal cancer (mGEC) with Gevokizumab, paclitaxel, ramucirumab Receives: Drug: Gevokizumab; Drug: Ramucirumab; Drug: Paclitaxel |
| Cohort D: 2nd or 3rd line renal cell carcinoma | Experimental | Treatment for 2nd or 3rd line metastatic renal cell carcinoma (mRCC) with Gevokizumab, cabozantinib Receives: Drug: Gevokizumab; Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1a/b (Cohorts A and B): Change in high-sensitivity C-reactive protein (hs-CRP) after first dose of gevokizumab monotherapy
Log scale change of hs-CRP at Day 15 from baseline
Measured: Baseline, Day 15
Part 1b (Safety run-in): Number of dose limiting toxicities (DLTs) [Cohort C and Cohort D]
DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the beginning of treatment with gevokizumab in combination with the SOC anti-cancer therapies and meets any of the protocol specified criteria.
Measured: First 4 weeks of combination treatment
Part 1b (Safety run-in): Number of DLTs [Cohort A and Cohort B]
DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the beginning of treatment with gevokizumab in combination with the SOC anti-cancer therapies and meets any of the protocol specified criteria.
Measured: First 6 weeks of combination treatment
Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort A subjects at RDE level]
PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1.
Measured: At 15 months
Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort B subjects at RDE level]
PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1.
Measured: At 9 months
Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort C subjects at RDE level]
PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1.
Measured: At 6 months
Secondary outcomes (7)
Overall response rate (ORR) per investigator assessment using RECIST v1.1
ORR is defined as the proportion of subjects with best overall response (BOR) of complete response (CR) or partial response (PR), according to RECIST 1.1
Measured: Up to 5 years
Duration of response (DOR) per investigator assessment using RECIST v1.1
Duration of response is defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria
Measured: Up to 5 years
Disease Control Rate (DCR) per investigator assessment using RECIST v1.1
DCR is defined as the proportion of subjects with a BOR of CR, PR, or stable disease (SD), according to RECIST 1.1.
Measured: Up to 5 years
Overall survival (OS)
OS is defined as the time from date of first dose of study treatment to date of death due to any cause.
Measured: Up to 5 years
PFS by baseline hs-CRP category using RECIST 1.1 [Cohort A and B at RDE level]
PFS is defined as the time from the date of first dosing of study drug to the date of the first documented progression or death due to any cause.
Measured: Up to 5 years
PFS for subjects from Part 1b at doses other than RDE level (Cohort A and Cohort B)
PFS is defined as the time from the date of first dosing of study drug to the date of the first documented progression or death due to any cause.
Measured: Up to 5 years
Number of patients with anti-drug antibodies for gevokizumab in the combination regimens
Incidence of immunogenicity for gevokizumab
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start22 May 2019
- Primary completion1 Mar 2023
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798626
- Sponsor's protocol ID
- CVPM087A2101
- Other IDs
- 2018-003952-19, 2018
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2019
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study of Gevokizumab in Combination With Standard of Care Anti-cancer Therapies in Patients With Metastatic Colorectal Cancer, Gastroesophageal Cancer and Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03798626
- Acronym / sponsor ID
- CVPM087A2101
- Keywords
- colorectal cancer, gastroesophageal cancer, renal cell carcinoma, gevokizumab, bevacizumab, modified FOLFOX6, FOLFIRI, ramucirumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 May 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
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 determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma, and the preliminary efficacy of gevokizumab in combination with the SOC anti-cancer therapy in subjects with mCRC and mGEC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A: 1st line colorectal cancer | Experimental | Drug: Gevokizumab, Drug: Bevacizumab, Drug: Modified FOLFOX6Treatment for 1st line metastatic colorectal cancer (mCRC) with Gevokizumab, modified FOLFOX6, bevacizumab |
| Cohort B: 2nd line colorectal cancer | Experimental | Drug: Gevokizumab, Drug: Bevacizumab, Drug: FOLFIRITreatment for 2nd line mCRC with Gevokizumab, FOLFIRI, bevacizumab |
| Cohort C: 2nd line gastroesophageal cancer | Experimental | Drug: Gevokizumab, Drug: Ramucirumab, Drug: PaclitaxelTreatment for 2nd line metastatic gastroesophageal cancer (mGEC) with Gevokizumab, paclitaxel, ramucirumab |
| Cohort D: 2nd or 3rd line renal cell carcinoma | Experimental | Drug: Gevokizumab, Drug: CabozantinibTreatment for 2nd or 3rd line metastatic renal cell carcinoma (mRCC) with Gevokizumab, cabozantinib |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adult ≥ 18 years old.
- Metastatic disease not amenable to potentially curative surgery and with available archival tumor tissue or fresh tumor tissue biopsy.
- Presence of at least 1 measurable lesion assessed by CT and/or MRI according to RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Adequate bone marrow and organ function per defined criteria in the protocol.
Key exclusion criteria (10 listed)
- Currently receiving any of the prohibited medications or has contraindications as outlined in the 'Contraindications' to SOC regimen components.
- Symptomatic brain metastases or brain metastases that require directed therapy (such as focal radiotherapy or surgery).
- Suspected or proven immunocompromised state, or infections (as defined in the protocol).
- Conditions that have a high risk of clinically significant bleeding after administration of anti VEGF agents.
- Clinically significant, uncontrolled or recent (within last 6 months) cardiovascular disease.
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 |
|---|---|---|
| GevokizumabAlso: VPM08760 mg/mL concentration; administered intravenously (IV) | Drug | Cohort A: 1st line colorectal cancer, Cohort B: 2nd line colorectal cancer, Cohort C: 2nd line gastroesophageal cancer, Cohort D: 2nd or 3rd line renal cell carcinoma |
| Bevacizumab25 mg/mL concentration; administered IV | Drug | Cohort A: 1st line colorectal cancer, Cohort B: 2nd line colorectal cancer |
| Modified FOLFOX6Also: oxaliplatin, leucovorin, 5-fluorouracilOxaliplatin [5 mg/mL concentration; administered IV], leucovorin [10 mg/mL concentration; administered IV] (or levoleucovorin [10 mg/mL concentration; administered IV]), and 5-fluorouracil [50 mg/mL concentration; administered IV] | Drug | Cohort A: 1st line colorectal cancer |
| FOLFIRIAlso: irinotecan, leucovorin, 5-fluorouracilIrinotecan [20 mg/mL concentration; administered IV], leucovorin [10 mg/mL concentration; administered IV] (or levoleucovorin [10 mg/mL concentration; administered IV]), and 5-fluorouracil [50 mg/mL concentration; administered IV] | Drug | Cohort B: 2nd line colorectal cancer |
| Ramucirumab10 mg/mL concentration; administered IV | Drug | Cohort C: 2nd line gastroesophageal cancer |
| Paclitaxel6 mg/mL concentration; administered IV | Drug | Cohort C: 2nd line gastroesophageal cancer |
| Cabozantinib60 mg tablet; administered orally | Drug | Cohort D: 2nd or 3rd line renal cell carcinoma |
Primary outcome
Part 1a/b (Cohorts A and B): Change in high-sensitivity C-reactive protein (hs-CRP) after first dose of gevokizumab monotherapy
Time frame: Baseline, Day 15
Log scale change of hs-CRP at Day 15 from baseline
Part 1b (Safety run-in): Number of dose limiting toxicities (DLTs) [Cohort C and Cohort D]
Time frame: First 4 weeks of combination treatment
DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the beginning of treatment with gevokizumab in combination with the SOC anti-cancer therapies and meets any of the protocol specified criteria.
Part 1b (Safety run-in): Number of DLTs [Cohort A and Cohort B]
Time frame: First 6 weeks of combination treatment
DLT is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the beginning of treatment with gevokizumab in combination with the SOC anti-cancer therapies and meets any of the protocol specified criteria.
Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort A subjects at RDE level]
Time frame: At 15 months
PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1.
Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort B subjects at RDE level]
Time frame: At 9 months
PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1.
Part 2 (Expansion) and Part 1b (Safety run-in): Progression free survival (PFS) rate [Cohort C subjects at RDE level]
Time frame: At 6 months
PFS rate is defined as the percentage of participants who have not progressed or died due to any cause within a specified timeframe after study treatment initiation. Progression will be assessed per investigator assessment using RECIST v1.1.
7 secondary outcomes
Overall response rate (ORR) per investigator assessment using RECIST v1.1
Time frame: Up to 5 years
Duration of response (DOR) per investigator assessment using RECIST v1.1
Time frame: Up to 5 years
Disease Control Rate (DCR) per investigator assessment using RECIST v1.1
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
PFS by baseline hs-CRP category using RECIST 1.1 [Cohort A and B at RDE level]
Time frame: Up to 5 years
PFS for subjects from Part 1b at doses other than RDE level (Cohort A and Cohort B)
Time frame: Up to 5 years
Number of patients with anti-drug antibodies for gevokizumab in the combination regimens
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Novartis Pharma AG resultsLink provided by the sponsor.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
34 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gevokizumab, Bevacizumab and Modified FOLFOX6 in people with Colorectal Cancer and Gastroesophageal Cancer, run by Novartis Pharmaceuticals at 34 sites in 15 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 20 inclusion and 10 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 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Spain, Japan, United States, Belgium, Germany and 10 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Part 1a/b (Cohorts A and B): Change in high-sensitivity C-reactive protein (hs-CRP) after first dose of gevokizumab monotherapy (time frame: Baseline, Day 15). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2026.