Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CC-93538 · 6 trials · 5 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.
Area under the concentration-time curve calculated from time zero to infinity
Maximum observed concentration of drug
Area under the concentration-time curve calculated from time zero to the last measured concentration
Area under the concentration-time curve calculated from time zero to infinity
Maximum observed concentration of drug
Time to Cmax
Terminal elimination half-life
Apparent clearance of drug from serum after extravascular administration
Apparent volume of distribution during the terminal phase
| 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. |
| CC-93538, 180mg/mL | EXPERIMENTAL | 26 healthy subjects will receive one injection of 2mL, 180mg/mL CC-93538 |
| CC-93538, 150mg/mL | EXPERIMENTAL | 26 healthy subjects will receive 2 injections of 1.2mL, 150mg/mL CC-93538 |
| CC-93538 in Japanese subjects | EXPERIMENTAL | Twenty-four Japanese subjects will be randomized into 1 of 2 dose levels in a 1:1 fashion so that 12 subjects will receive a 180 mg or 360 mg dose via SC injection. |
| Administration of CC-93538 in Caucasian subjects | EXPERIMENTAL | Twenty-four Caucasian subjects will be matched to Japanese subjects by weight (± 20%) and receive a 180 mg or 360 mg dose via SC injection |
| Name | Type | Description |
|---|---|---|
| CC-93538 | DRUG | CC-93538 |
| Placebo | 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 |
| Smith & Nephew plc Sponsored ADR | SNN | 1 | - | Undisclosed |
CC-93538 is an investigational small molecule being studied for eosinophilic esophagitis, atopic dermatitis, and eosinophilic gastroenteritis. It has also been evaluated in healthy volunteers. The drug is being developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 2 clinical development.
CC-93538 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials of this investigational small molecule in conditions such as eosinophilic esophagitis and atopic dermatitis.
CC-93538 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for eosinophilic esophagitis, atopic dermatitis, and healthy volunteer studies, with the drug being studied in adult and adolescent participants.
CC-93538 has completed several clinical trials. NCT04753697 and NCT04991935 evaluated the drug in eosinophilic esophagitis, NCT04800315 studied it in moderate to severe atopic dermatitis, and NCT04096105 was a pharmacokinetic bridging study in healthy volunteers. All trials are completed.
Yes, CC-93538 is also known as cendakimab. In a completed Phase 2 trial, the drug was referred to as cendakimab (CC-93538) when studied in participants with moderate to severe atopic dermatitis.
CC-93538 is being developed in the therapeutic area of dermatology. Its clinical trials have focused on eosinophilic esophagitis, atopic dermatitis, and eosinophilic gastroenteritis, with studies conducted in multiple countries including the United States, Japan, and Canada.