Approval Probability
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Also known as CC-93538, BMS-986355, RPC4064
Cendakimab · 5 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. |
| Administration of Cendakimab and Cytochrome P450 (CYP) substrates | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CC-93538 | DRUG | CC-93538 |
| Placebo | DRUG | Specified dose on specified days |
| 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 |
Cendakimab is an investigational monoclonal antibody developed by Bristol-Myers Squibb Company (ticker: BMY) for eosinophilic esophagitis, a gastrointestinal condition. It is in Phase 1 clinical development and has been studied in a completed Phase 1 trial. Cendakimab is not approved; it remains under clinical investigation.
Cendakimab is being developed for eosinophilic esophagitis, a chronic inflammatory condition of the esophagus. It is an investigational therapy and has not been approved for any indication. Its only reported clinical trial enrolled adults with active eosinophilic esophagitis.
Cendakimab targets interleukin-13 (IL-13), a cytokine involved in type 2 inflammatory responses. It is a monoclonal antibody that acts as an IL-13 inhibitor. By binding IL-13, cendakimab is designed to interfere with signaling that contributes to eosinophilic inflammation in eosinophilic esophagitis.
Cendakimab is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. Bristol-Myers Squibb is the sponsor of the clinical trial evaluating cendakimab in eosinophilic esophagitis.
Cendakimab is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are reported. The drug is investigational and has not been approved by the FDA for any use.
Cendakimab has been evaluated in a completed Phase 1 trial, NCT05175352, titled a study evaluating potential disease-mediated drug-drug interaction in adult participants with active eosinophilic esophagitis receiving cendakimab. The trial enrolled 16 adults in the United States and was uncontrolled, non-randomized, and not double-blind.