A Phase 2 Study of Jaktinib in Participants With Moderate to Severe Psoriasis (PSO)

Zelgen Biopharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Moderate-to-Severe Plaque Psoriasis

Treatments: Drug: Placebo; Drug: Jaktinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04612699

ZGJAK010

Details and patient eligibility

About

This is study designed to investigate the efficacy and safety of Jaktinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.

Enrollment: 123 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18~65 years old (including lower limit), no gender limit；
• You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study；
• You must have active plaque psoriasis covering at least 10% body surface area； You must have Psoriasis Area and Severity Index (PASI) score of at least 12；You must have Static Physician's Global Assessment (sPGA) score of at least 3；
• The patient can communicate well with the investigator and follow the research and follow-up procedures；
• Understand and voluntarily sign the informed consent form.

Exclusion criteria

• You must not have prior treatment with an oral Janus kinase (JAK) inhibitor；
• You must not have received a phototherapy within 4 weeks prior to entry into the study；
• You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)；
• You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

123 participants in 4 patient groups, including a placebo group

Jaktinib 50mg Bid

Experimental group

Description:

Jaktinib 50mg Bid+ Placebo 50mg Bid+ Placebo 75mg Bid

Treatment:

Drug: Jaktinib

Drug: Placebo

Jaktinib 75mg Bid

Experimental group

Description:

Jaktinib 75mg Bid+ Placebo 50mg\*2 Bid

Treatment:

Drug: Jaktinib

Drug: Placebo

Jaktinib 100mg Bid

Experimental group

Description:

Jaktinib 50mg\*2 Bid+ Placebo 75mg Bid

Treatment:

Drug: Jaktinib

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo 50mg\*2 Bid+ Placebo 75mg Bid

Treatment:

Drug: Placebo