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Open Label Study to Evaluate the Safety and Efficacy of AK101 Injection Subcutaneously in Subjects With Psoriasis

Sponsored by Akeso

About this trial

Last updated 3 years ago

Study ID

AK101-303

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

This is an open-label Phase III clinical study to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis.

What are the Participation Requirements?

Key Inclusion Criteria:

- Applicable for subjects who have completed the previous Akeso trial (AK101-302) with
AK101 injection:

1. Subjects can continue to participate in this study based on assessment of
investigator.

2. Subjects voluntarily participate in this study.

3. Subjects who are women of childbearing potential must be practicing an adequate,
medically acceptable method of birth control during the treatment period and for
at least 6 months after the last study drug administration.

- Applicable for subjects newly enrolled:

1. Male or female subjects aged ≥ 18 years old.

2. Subjects diagnosed with moderate-to-severe plaque psoriasis and are applicable to
systematic treatment.

3. At screening and baseline, PASI score ≥ 12, Body Surface Area BSA (BSA) ≥ 10%,
sPGA ≥ 3.

4. Subjects who are applicable for biological agents, based on the assessment of
investigator.

5. Subjects who are women of childbearing potential must have a negative pregnancy
test at screening and must be practicing an adequate, medically acceptable method
of birth control for at least 6 months after the last study drug administration.

Key Exclusion Criteria:

- Applicable for subjects who have completed the previous Akeso trial (AK101-302) with
AK101 injection:

1. Subjects who have severe AE or SAE occurred in an Akeso trial with AK101
injection.

2. Subjects who used prohibited drugs in an Akeso trial with AK101 injection.

3. Subjects performed poor compliance in an Akeso trial with AK101 injection, based
on the assessment of investigator.

4. Subjects with any other disease, abnormal physical examination or abnormal
laboratory examination leading to inapplicable for participating this study,
based on the assessment of investigator.

- Applicable for subjects newly enrolled:

1. Forms of psoriasis other than chronic plaque-type psoriasis.

2. History or evidence of active TB. Patients with evidence of latent tuberculosis
may enter the trial after sufficient treatment had initiated and maintained
according to protocol.

3. Positive results of confirmatory test for hepatitis B, hepatitis C, human
immunodeficiency virus (HIV) or syphilis.

4. History of repeated chronic infection, had any serious infection or systemic
infection within 2 months before screening.

5. History of prohibited psoriasis treatments within 2/4 weeks before randomization.

6. History of IL-12/23 or IL-23 inhibitors therapy.

7. Inadequate washout period of prior biological therapy.

8. History of malignant tumour within 5 years before screening.

9. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the
opinion of the Investigator would place the subject at risk, interfere with
participation or interpretation of the study.

Locations

Location

Status

Recruiting