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Also known as Cendakimab, CC-93538, BMS-986355
RPC4046 · 6 trials · 4 indications
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization.
Blood samples were collected to assess clinical significant shifts in laboratory parameters. "Normal to High" means at baseline the value is Normal and maximum post baseline value is High.
SBP (Systolic blood Pressure) and DBP (Diastolic Blood Pressure) measured in mmHg and Heart rates measured in beats per minute.
Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase.
Dysphagia Days (DD) was assessed using a modified daily symptom diary (mDSD). The DD was evaluated over the prior 14-day period using the mDSD, which includes 6 primary questions. These questions assess solid food consumption that day (Q1), experience with trouble swallowing (Q2), food going down slowly (Q3), food getting stuck in the throat or chest (Q4), actions taken by participants to obtain relief (Q5), and any pain associated with swallowing (Q6). The number of DD was normalized by calculating the number of diary days with a "yes" to any or all of Q2, Q3, and Q4 in the 14-day period prior to a visit, dividing by the number of measurable diary days in the 14-day period, and then multiplying by the length of the period (14). A measurable diary day for DD is defined as a diary day for which Questions 2 to 4 are answered. Mean DD ranges from 0 to 14 for the 14-day period.
Blood samples were collected to assess esophageal eosinophil count.
The Eczema Area and Severity Index (EASI) is a composite scoring system assessed by the Investigator based on the proportion of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with Atopic Dermatitis (AD) and the intensity of each of 4 main signs of AD (eg, erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (none), 1 (mild), 2 (moderate), and 3 (severe). The sum of the scores is totaled (0 to 72), the lower the score the better.
| Arm | Type | Description |
|---|---|---|
| Administration of CC-93538 | EXPERIMENTAL | Participants are administered CC-93538 dose subcutaneously once weekly |
| CC-93538 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Administration of CC-93538 and Placebo | EXPERIMENTAL | CC-93538 360 mg SC once weekly for 24 weeks followed by CC-93538 360 mg SC once every other week for 24 weeks. During the Maintenance Phase, matching placebo will be administered once every other week on alternate weeks to maintain the blind. |
| Administration of Placebo | PLACEBO_COMPARATOR | Matching placebo SC once weekly for 24 weeks followed by matching placebo SC once weekly for 24 weeks |
| Dose 1: CC-93538 SC QW | EXPERIMENTAL | Administration of CC-93538 Subcutaneous (SC) Once weekly (QW) for 16 weeks. |
| Dose 2: CC-93538 SC Q2W and Placebo alternating every other week SC Q2W | EXPERIMENTAL | Starting at the baseline visit, active IP will be administered. On the alternate weeks, placebo will be administered to maintain the blind. |
| Dose 3: CC-93538 SC Q2W and Placebo SC weekly | EXPERIMENTAL | Starting at the baseline visit, active IP and matching placebo will be administered. On the alternate weeks, placebo will be administered weekly to maintain the blind. |
| Placebo SC QW | PLACEBO_COMPARATOR | Administration of placebo each week. |
| RPC4046 Low Dose | EXPERIMENTAL | intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose |
| RPC4046 High Dose | EXPERIMENTAL | intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose |
| Administration of Cendakimab and Cytochrome P450 (CYP) substrates | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CC-93538 | DRUG | CC-93538 |
| Placebo | DRUG | Specified dose on specified days |
| RPC4046 | DRUG | - |
| Cendakimab | DRUG | Specified dose on specified days |
| CYP substrates | DRUG | Specified dose on specified days |
Inclusion Criteria: * Previously participated in prior clinical study CC-93538-EE-001 and either: 1. Subject experienced a severe EoE flare requiring endoscopic intervention and/or concomitant rescue therapy during the Induction Phase and has completed Week 24 of the Induction Phase; OR 2. Sub...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tezepelumab |
| Regeneron Pharmaceuticals, Inc. | REGN | 3 | PHASE3 | dupilumab |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | PHASE2 | Vonoprazan |
| Eupraxia Pharmaceuticals, Inc. | EPRX | 1 | PHASE1 | EP-104GI |
| Sanofi SA Sponsored ADR | SNY | 1 | - | Dupilumab |
RPC4046 is an investigational monoclonal antibody being developed for eosinophilic esophagitis, a chronic inflammatory condition of the esophagus. It is in Phase 2 clinical development and has not been approved for any indication. Bristol-Myers Squibb Company is the developer.
RPC4046 has been studied in one completed Phase 2 trial, NCT02098473, titled Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis. The trial enrolled 100 participants across the United States, Canada, and Switzerland. It was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.
RPC4046 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is responsible for the clinical development of the monoclonal antibody in eosinophilic esophagitis.
RPC4046 is in Phase 2 clinical development for eosinophilic esophagitis. The only listed trial, NCT02098473, is a completed Phase 2 dose-ranging study. There are no active trials for RPC4046 at this time, and the drug remains investigational.
RPC4046 is not approved by the FDA. It is an investigational monoclonal antibody in Phase 2 clinical development for eosinophilic esophagitis. The completed Phase 2 trial, NCT02098473, evaluated the drug in 100 participants, but no regulatory approval has been granted.