Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0MPDIB)
| ADC Name |
ABBV-154
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| Synonyms |
ABBV-154
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| Organization |
AbbVie (Top20 MNC) (Originator)
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| Drug Status |
Phase 2 (discontinued)
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
Adalimumab
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Antibody Info | ||||
| Antigen Name |
Tumor necrosis factor (TNF)
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Antigen Info | ||||
| Payload Name |
Glucocorticoid receptor modulator
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Payload Info | ||||
| Payload Target |
Glucocorticoid receptor (NR3C1)
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Target Info | ||||
| Linker Name |
Formyl-Gly-Glu
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible participants must have a BMI between 18.0 and 29.9 kg/m2. Key exclusions include use of medications/supplements within 2 weeks (or 5 half-lives), prior exposure to similar biologic therapies, and history of significant medical conditions (e.g., epilepsy, cardiac/respiratory/neurologic disorders, or uncontrolled illnesses).
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT05556226 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of ABBV-154 | ||||
| Primary Endpoint |
This study evaluates the pharmacokinetic profile of the investigational drug over approximately 58 days, measuring key parameters including Cmax, Tmax, terminal elimination rate constant (beta), half-life (t1/2), and AUC values (AUCt and AUC∞). Safety is assessed through adverse event monitoring for approximately 72 days, with investigators determining causality between reported AEs and study treatment.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Comprehensive efficacy assessments focused on joint count improvements, composite disease activity scores, and patient-reported outcomes to evaluate treatment response, disease control, and functional status in this biologic-refractory RA population.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT04888585 | Clinical Status | PHASE2 | ||
| Clinical Description | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs) | ||||
| Primary Endpoint |
The primary endpoint was achieving ACR50 response at Week 12, defined as ≥50% improvement in tender/swollen joint counts and ≥50% improvement in 3 of 5 additional measures including physician/patient global assessments, pain score, HAQ-DI, and hsCRP. Secondary endpoints included changes in DAS28 and CDAI scores, with lower scores indicating improvement, as well as ACR20/70 responses, low disease activity (DAS28 ≤3.2 or CDAI ≤10), clinical remission (DAS28 <2.6 or CDAI ≤2.8), and HAQ-DI improvement from baseline.
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| Other Endpoint |
Key inclusion criteria required confirmed RA diagnosis per 2010 ACR/EULAR criteria with ≥6 swollen/tender joints at baseline, inadequate response to prior biologics/tsDMARDs, and stable MTX dose. Exclusion criteria included prior discontinuation of adalimumab due to intolerance/toxicity.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
The study evaluated disease stability under glucocorticoid tapering by measuring flare events, steroid exposure reduction, and sustained remission in this recurrent PMR population.
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| Administration Dosage |
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| NCT Number | NCT04972968 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment | ||||
| Primary Endpoint |
The primary endpoint was time to PMR flare (requiring glucocorticoid dose increase) from first dose through Week 52. Secondary endpoints included flare-free status rates, cumulative glucocorticoid dose, and dose changes from baseline by Week 24.
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| Other Endpoint |
Eligible participants required confirmed PMR diagnosis per 2012 EULAR/ACR criteria with ≥2 prior flares, stable prednisone use, and willingness to follow protocol tapering. Key exclusions included prior TNF antagonist treatment or concurrent immunomodulators beyond prednisone/hydroxychloroquine.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
The study aimed to demonstrate mucosal healing and sustained clinical remission in moderate-to-severe CD patients refractory to multiple biologics, using comprehensive endoscopic and symptom-based assessments.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT05068284 | Clinical Status | PHASE2 | ||
| Clinical Description | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD | ||||
| Primary Endpoint |
The primary endpoint was endoscopic response (SES-CD reduction >50% or ≥2-point decrease in isolated ileal disease) at Week 12. Secondary endoscopic and clinical endpoints included SES-CD response at Week 40 and clinical remission (CDAI <150 or stool frequency/abdominal pain criteria) at Weeks 12 and 40.
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| Other Endpoint |
Eligible participants required confirmed CD diagnosis ≥3 months, CDAI 220-450, and SES-CD ≥6 (≥4 for isolated ileal disease), with prior biologic failure/intolerance. Key exclusion was prior adalimumab intolerance.
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| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT04888585 | Clinical Status | Phase 2 | ||
| Clinical Description | A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of ABBV-154 in subjects with moderately to severely active rheumatoid arthritis with inadequate response to biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsdmards). | ||||
| Experiment 6 Reporting the Activity Date of This ADC | [6] | ||||
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| NCT Number | NCT04972968 | Clinical Status | Phase 2 | ||
| Clinical Description | A phase 2, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety and efficacy of ABBV-154 in subjects with polymyalgia rheumatica (PMR) dependent on glucocorticoid treatment. | ||||
| Experiment 7 Reporting the Activity Date of This ADC | [7] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05068284 | Clinical Status | Phase 2 | ||
| Clinical Description | A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of ABBV-154 in subjects with moderately to severely active crohn's disease (CD): aim-cd. | ||||
| Experiment 8 Reporting the Activity Date of This ADC | [8] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05556226 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 study in healthy subjects to evaluate the relative bioavailability of ABBV-154. | ||||
References