A Phase 3 interventional study of AK101 injection SC in Plaque Psoriasis, sponsored by Akeso. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Akeso · Phase 3, Interventional, and Treatment
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.
This is an open-label, single-arm, multi-center phase III study. The purpose of this study is to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis. Subjects who have completed the previous Akeso registration trial with AK101 injection (AK101-302) and subjects who are to be newly enrolled will both receive AK101 135mg injection subcutaneously.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 950 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Key Inclusion Criteria:
Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:
Applicable for subjects newly enrolled:
Key Exclusion Criteria:
Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:
Applicable for subjects newly enrolled:
Subjects who have completed AK101-302 receive AK101 135mg injection subcutaneously every 12 weeks. Subjects newly enrolled receive AK101 135mg injection subcutaneously at Week 0, 4 and then every 12 weeks.
Biological: AK101 injection SC
AK101 is supplied as 135 mg doses, provided in 1 mL prefilled syringes.
Occurrence of Treatment-Emergent Adverse Event
To evaluate long-term safety as assessed by occurrence of TEAE.
Time frame: up to 52 weeks
Occurrence of Serious Adverse Event and Adverse Events of Special Interest
To evaluate long-term safety as assessed by occurrence of SAE and AESI.
Time frame: up to 52 weeks
Percentage of Subjects Who Achieved at least 50% (PASI 50), 75% (PASI 75) and 90% (PASI 90) Reduction in Psoriasis Area and Severity Index (PASI) Score
PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 50, PASI75 and PASI 90 were defined as participants achieving \>= 50%, \>= 75% or \>= 90% improvement from baseline, respectively.
Time frame: up to 52 weeks
Percentage of Subjects Who Achieved Static Physician Global Assessment (sPGA) Clear(0) or Almost Clear(1)
The sPGA is an instrument providing a subjective evaluation of the overall severity of psoriasis, based on severity of induration, scaling, and erythema. The scores are: 0 = clear; 1 = minimal; 2 = mild; 3 = moderate; 4 = marked; 5 = severe.
Time frame: up to 52 weeks
Pharmacokinetics Assessment of AK101 Serum Concentration
Time frame: up to 52 weeks
Immunogenicity Assessment with Number and Percentage of Subjects with Detectable Anti-AK101 Antibody (ADA)
Time frame: up to 52 weeks
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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