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CCX140-B

Phase 2

Diabetic Nephropathy | Small molecule | Metabolic |Amgen Inc.|Last Updated: Mar 13, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment352

FDA Designations

No designations recorded

Clinical trial landscape

CCX140-B · 4 trials · 5 indications

Phase 2 4
NCT03536754A Study of CCX140-B in Subjects With FSGSFSGS
COMPLETED46 Analytics
NCT01447147A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic NephropathyDiabetic Nephropathy
COMPLETED332 Analytics
NCT01440257A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and AlbuminuriaDiabetic Nephropathy
COMPLETED20 Analytics
NCT01028963A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Type 2 Diabetes MellitusType 2 Diabetes Mellitus
COMPLETED159 Analytics
PHASE2COMPLETED
A Study of CCX140-B in Subjects With FSGS
FSGS
NCT0353675446
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PHASE2COMPLETED
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy
Diabetic Nephropathy
NCT01447147332
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PHASE2COMPLETED
A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria
Diabetic Nephropathy
NCT0144025720
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PHASE2COMPLETED
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus
NCT01028963159
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Study Endpoints

Primary Endpoints

Change From Baseline in UPCR at Week 12
Baseline to Week 12

Least squared mean ratio of UPCR (Urine protein g:creatinine g) compared to baseline at Week 12 in the ITT population. ITT- Intent to treat

Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs)
Baseline to Week 12, and Week 12 to Week 24

TEAEs leading to study withdrawal means study drug discontinuation in this endpoint.

Change From Baseline in Activated Partial Thromboplastin Time
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal Range: 23.9 - 40.0

Change From Baseline in Plasma Alanine Aminotransferase
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal Range: 6 - 41 U/L

Change From Baseline in Plasma Alkaline Phosphatase
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Amylase
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 22-123 U/L

Change From Baseline in Plasma Aspartate Aminotransferase
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range : 9-34 U/L

Change From Baseline in Plasma Bicarbonate
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 21-33 mmol/L

Change From Baseline in Plasma Bilirubin
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 0.1-1.10 mg/dL

Change From Baseline in Plasma C Reactive Protein
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 0.0-3.0 mg/L

Change From Baseline in Plasma Calcium
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 8.5-10.5 mg/dL

Change From Baseline in Plasma Chloride
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 95-110 mmol/L

Change From Baseline in Plasma Cholesterol
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 100-200 mg/dL

Change From Baseline in Plasma Creatine Kinase
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 23-210 U/L

Change From Baseline in Plasma Creatinine
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 0.62-1.44 mg/dL

Change From Baseline in Plasma Cystatin C
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Normal range: 0.53-0.95 mg/L

Change From Baseline in Plasma Direct Bilirubin
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Glucose
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma HDL Cholesterol
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

HDL -High-density lipoprotein

Change From Baseline in Plasma Indirect Bilirubin
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma LDL Cholesterol
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

LDL - Low-density lipoprotein

Change From Baseline in Lactate Dehydrogenase
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Pancreatic Lipase
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Magnesium
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Phosphate
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Potassium
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Protein
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Prothrombin Intl. Normalised Ratio
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Prothrombin Time
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Sodium
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Triglycerides
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Urate
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Urea Nitrogen
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Basophils
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Basophils/Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Eosinophils
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Eosinophils/Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

HGB - Hemoglobin

Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocyte Mean Corpuscular Volume
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Hematocrit
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Hemoglobin
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Lymphocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Lymphocytes/Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Monocytes/Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Neutrophils
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Neutrophils/Leukocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Platelets
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Reticulocytes/Erythrocytes
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Urine Albumin
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Urine Creatinine
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Urine Protein
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Subject incidence of adverse events
Up to 365 days

The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy.

Change from baseline in 24-hour urinary albumin excretion
84 days

The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary albumin excretion by measuring change from baseline in 24-hour urinary albumin excretion.

Secondary Endpoints

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24
Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Proportion of Subjects Achieving Complete or Partial Renal Remission at Week 12 and Week 24
Endpoint at Week 12 for Double-Blind Treatment Period and Endpoint at Week 24 for Open-Label Extension
Change from baseline in first morning urinary albumin:creatinine ratio (ACR)
Up to 365 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group APLACEBO_COMPARATORPlacebo (N=10)
Group BEXPERIMENTALCCX140-B 5 mg once daily (N=10)
Group CEXPERIMENTALCCX140-B 10 mg twice daily (N=10)
Group DEXPERIMENTALCCX140-B 15 mg twice daily (N=10)
Placebo (Group A)PLACEBO_COMPARATOR -
CCX140-B (Group B)EXPERIMENTAL -
CCX140-B (Group C)EXPERIMENTAL -
Active study medication (Group B)EXPERIMENTALCCX140-B
PlaceboPLACEBO_COMPARATOR -
Active controlACTIVE_COMPARATOR -
Active Study Medication (Group C)EXPERIMENTALCCX140-B
Active Study Medication (Group D)EXPERIMENTALCCX140-B

Interventions

NameTypeDescription
PlaceboOTHERThree placebo tablets, taken twice daily (BID), per os, for 84 days (12 weeks)
CCX140-BDRUGOne 5 mg CCX140-B tablet and 2 placebo tablets in the morning; 3 placebo tablets in the evening; per os, for 84 days.
pioglitazoneDRUGpioglitazone 30 mg tablet once daily
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: 1. Male or female subjects aged 18-75 2. UPCR ≥ 1 g protein/g creatinine (or at 113 mg.mmol) at screening 3. Diagnosis of FSGS based on renal biopsy or high risk genetic variant 4. Diagnosis of one of primary FSGS based on characteristic histopathology, medical history and clini...

Countries:United StatesAustraliaCanadaFranceItalyNew ZealandPolandUnited KingdomBelgiumCzechiaGermanyHungaryNetherlands
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Competitive Landscape -Diabetic Nephropathy 8 trials

CompanyTickerTrialsLead PhaseDrugs
DexCom, Inc.DXCM1PHASE3Sotagliflozin
Regeneron Pharmaceuticals, Inc.REGN1PHASE2ALN-ANG3, Evinacumab
Novartis AG Sponsored ADRNVS1PHASE2Atrasentan
ProKidney Corp. Class APROK2 - Renal Autologous Cell Therapy
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Frequently asked questions about CCX140-B

What is CCX140-B used for?

CCX140-B is an investigational small molecule being studied for diabetic nephropathy, type 2 diabetes mellitus, and focal segmental glomerulosclerosis (FSGS). It has been evaluated in Phase 2 clinical trials for these metabolic and kidney-related conditions.

Who makes CCX140-B?

CCX140-B is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 2 clinical development.

What phase is CCX140-B in?

CCX140-B is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All four clinical trials for CCX140-B have been completed, with no active trials currently ongoing.

What clinical trials is CCX140-B in?

CCX140-B has been studied in four completed Phase 2 trials: NCT01028963 in type 2 diabetes mellitus with 159 participants, NCT01440257 in diabetic nephropathy with 20 participants, NCT01447147 in diabetic nephropathy with 332 participants, and NCT03536754 in FSGS with 46 participants.

Is CCX140-B the same as other names?

CCX140-B is the primary name for this investigational drug. No alternative names have been reported for this compound in the available clinical trial data.