Clinical trial NCT05258331: Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With Psoriasis
Official title: An Open-label, Dose-escalation, Phase 1 Trial to Investigate the Safety, Tolerability, and Efficacy After Single- and Multiple-dose Administration of CT303 in Patients With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Moderate to Severe Plaque Psoriasis
Keywords: Psoriasis
Lead sponsor: GC Cell Corporation
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigate the Safety, Tolerability, Efficacy and pharmacodynamics properties of CT303 in patients with moderate to severe plaque psoriasis

Detailed description: This study is a multi-center, open-label, dose-escalation and dose-finding phase 1 clinical trial. The primary purpose is to evaluate the safety and tolerability of CT303 and the secondary purpose is to evaluate the safety and efficacy of CT303 in patients with moderate to severe plaque psoriasis.

Eligibility criteria: Inclusion Criteria:

1. ≥ 19 years old
2. Plaque psoriasis diagnosed before ≥ 6 months who did not show a sufficient response to one or more of the traditional systemic treatments or require change of treatment due to intolerance
3. Have moderate to severe plaque psoriasis as defined by PASI score ≥ 12, BSA ≥ 10% and sPGA score ≥ 3
4. Patients who have voluntarily decided to participate in the study and signed the informed consent form

Exclusion Criteria:

1. Guttate psoriasis, erythrodermic psoriasis, palmoplantar psoriasis, drug-induced psoriasis, and inverse psoriasis
2. History of treatment with cell therapy products including but not limited to mesenchymal stem cells
3. Have hypersensitivity, or medical history of clinically significant hypersensitivity, to the IP or its excipients
4. Current or history of cardiovascular diseases
5. Clinically significant hemorrhagic diseases, or gastrointestinal, respiratory, endocrinal, musculoskeletal, or neuropsychiatric disorders that are deemed by the investigator to be a potential threat to the safety of the subject due to study participation
6. Use of anticoagulants within 7 days prior to IP administration
7. Following treatment history for psoriasis

   * Use of topical therapy within the past 2 weeks
   * Use of phototherapy and/or systemic therapy within the past 4 weeks
   * Use of biologics within the past 4 to 24 weeks
8. Severe infection or other uncontrolled active infectious diseases requiring administration of systemic antibiotics, antivirals, etc. within 4 weeks prior to IP administration
9. Systemic or local inflammatory diseases requiring systemic anti-inflammatory treatment within 4 weeks prior to IP administration
10. Received or are scheduled to receive a live/live attenuated viral/bacterial vaccination within 12 weeks prior to IP administration (within 12 months for BCG vaccines)
11. Require administration of any prohibited concomitant medication specified in this protocol during participation in the study
12. QTc interval \> 480 msec
13. Any of the following abnormalities or abnormal findings from laboratory tests:

    * AST or ALT \> 3 times the upper limit of normal
    * Serum creatinine \> 1.5 times the upper limit of normal
    * ANC \< 1,500/μL, Hemoglobin \< 10 g/dL, Platelet count \< 100,000/μL
14. Hepatitis B or C infection or positive test for HIV at screening
15. History of malignant tumors within the last 5 years prior
16. Received or used any other IP or investigational device within 4 weeks prior to IP administration
17. Pregnant or breast-feeding women, or women of childbearing potential and men who do not agree to abstinence or use of effective methods of contraception from the time of obtaining informed consent and during the study
18. Patients who are deemed ineligible to participate in the study for other reasons by the investigator

Primary outcomes:
measure: TEAE (treatment-emergent adverse event) incidence rate
timeFrame: Day 0 to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Medical School Bundang CHA Medical Center
city: Pusan
country: Korea, Republic of
facility: Pusan national university hospital
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Seoul National University Hospital
name: Seongjin Jo
role: PRINCIPAL_INVESTIGATOR
References: