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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

567

A total of 567 study participants were randomized and started the Initial treatment Period as follows: 321 study participants in the bimekizumab 320mg Q4W group, 163 study participants in the ustekinumab group, and 83 study participants in the placebo group. The mean age of all study participants was 46.1 years of age with a range of 18 to 81 years of age. The majority of study participants were male (71.6%), White (74.1%), and not of Hispanic or Latino ethnicity (93.5%). The mean body weight and mean body mass index were 88.352kg and 29.57kg/m2, respectively.

A total of 537 study participants completed the Initial treatment Period as follows: 306 (95.3%) in the bimekizumab 320mg Q4W group, 157 (96.3%) in the ustekinumab groups and 74 (89.2%) in the placebo group. A total of 493 study participants completed the study as follows: 283 (92.5%) in the bimekizumab 320mg Q4W group, 141 (89.8%) in the ustekinumab group, and 69 (93.2%) in the placebo/bimekizumab 320mg Q4W group (who switched from placebo to bimekizumab 320 mg Q4W at week 16).

Mortality in the iInitial treatment period (up to week 16) were reported 1 (0.31%) of 321 in the bimekizumab 320 mg Q4W group, 1 (0.61%) of 163 in the ustekinumab group and 1 (1.20%) of 83 in the placebo group. Through Initial and maintenance treatment period (from week 0 to week 52), Mortality was reported 2 (0.51%) of 395 in the bimekizumab 320 mg Q4W group, and 1 (0.61%%) of 163 in the ustekinumab group. Serious adverse events (SAEs) in the Initial treatment period were reported 5 (1.56%) of 321 in the bimekizumab 320 mg Q4W group, 5 (3.97%) of 163 in the ustekinumab group and 2 (2.41%) of 83 in the placebo group. Through all treatment period, SAEs were reported 24 (6.08%) of 395 in the bimekizumab 320 mg Q4W grouup, and 13 (7.98%) of 163 in the ustekinumab group. Treatment-emergent adverse events except serious adverse events (TEAEs) in the Initial treatment period were reported 87 (27.1%) of 321 in the bimekizumab 320 mg Q4W group, 37 (22.7%) of 163 in the ustekinumab group and 17 (20.48%) of 83 in the placebo group. Through Initial and maintenance treatment period (weeks 0 -52), TEAEs were reported 192 (48.61%) of 395 in the bimekizumab 320 mg Q4W group, and 73 (44.79%) of 163 in the ustekinumab group. Common TEAEs in the Initial treatment period, Nasopharyngitis was reported 30 (9.35%) of 321 in the bimekizumab 320 mg Q4W group, 14 (8.59%) of 163 in the ustekinumab group, and 7 (8.43%) of 83 in the placebo group. Oral candidiasis was reported 28 (8.72%) of 321 in the bimekizumab 320 mg Q4W group, 0 participant was in the ustekinumab group or the placebo group. Upper respiratory tract infection was reported 9 (2.8%) of 321 in the bimakizumab 320 mg Q4W group, 5 (3.07%) of 163 in the ustekinumab group, 2 (2.41%) of 83 in the placebo group. Urinary tract infection was reported 6 (1.87%) of 321 in the bimekizumb 320 mg Q4W group, 1 (0.61%) of 163 in the ustekinumab group, 5 (6.02%) of 83 in the placebo group.

At week 16, PASI90 response was reached 85% in the bimekizumab 320 mg Q4W group, 50% in the ustekinumab group, and 5% in the placebo group. At week 16, IGA response was reached 84% in the bimekizumab 320 mg Q4W group, 53% in the ustekinumab group, and 5% in the placebo group.

At week 16, PASI100 response was reached 58.6% in the bimekizumab 320 mg Q4W group, 20.9% in the ustekinumab group, and 0% in the placebo group. At week 16, IGA 0 response was reached 58.6% in the bimekizumab 320 mg Q4W group, 22.1% in the ustekinumab group, and 0% in the placebo group.

567 were enrolled and randomly assigned (bimekizumab 320 mg Q4W group n=321, ustekinumab group n=163, placebo group n=83). At week 16, 85% and 84% in the bimekizumab 320 mg Q4W group had PASI90 response and IGA response. Over 52 weeks, serious treatment-emergent adverse events were reported in 24 (6%) of 395 patients in the bimekizumab group (including those who switched from placebo to bimekizumab 320 mg Q4W at week 16).

Feb. 06, 2021

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00125-2/fulltext

No

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo

CTR_SCC_UCBJapan@UCB.com

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo

CTR_SCC_UCBJapan@UCB.com

completed

Mar. 22, 2018

Interventional

Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study

treatment purpose

3

- Must be at least 18 years of age
- Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
- Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale
- Subject is a candidate for systemic PSO therapy and/or phototherapy
- Female subject of child bearing potential must be willing to use highly effective method of contraception

- Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic or recurrent chronic infections
- Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
- Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
- Presence of active suicidal ideation or positive suicide behavior
- Presence of moderately severe major depression or severe major depression
- Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer

Both

Plaque Psoriasis
Psoriatic Arthritis

investigational material(s)
Generic name etc : UCB4940
INN of investigational material : bimekizumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : 320mg administered by sc injection

control material(s)
Generic name etc : ustekinumab
INN of investigational material : ustekinumab
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : For subjects weighing =<100kg, 45mg administered by sc injection
For subjects weighing >100kg, 90mg administered by sc injection
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

efficacy
1. Psoriasis Area and Severity Index 90 (PASI90) response at Week 16
2. Investigator's Global Assessment (IGA) response at Week 16

safety
efficacy
1. PASI100 response at Week 16
2. PASI75 response at Week 4
3. Patient Symptom Diary response for itch at Week 16
4. Patient Symptom Diary response for pain at Week 16
5. Patient Symptom Diary response for scaling at Week 16
6. Scalp IGA response (Clear or Almost Clear with at least a 2-category improvement from Baseline) at Week 16 for subjects with scalp psoriasis (PSO) at Baseline
7. PASI90 response at Week 12
8. PASI90 response at Week 52
9. IGA response at Week 12
10. IGA response at Week 52
11. Number of Treatment Emergent Adverse Events (TEAEs) adjusted by duration of subject exposure to study treatment
12. Number of Serious Adverse Events (SAEs) adjusted by duration of subject exposure to study treatment
13. Number of TEAEs leading to withdrawal adjusted by duration of subject exposure to study treatment

Dec. 26, 2017