NCT02203851

Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab in Patients With Moderate to Severe Chronic Plaque Psoriasis

Completed Phase 2 Results posted Last updated 8 November 2019

What this trial tests

Phase 2 trial testing Risankizumab in Psoriasis in 110 participants. Completed in 4 September 2018.

Timeline

20 November 2014

Primary endpoint
4 September 2018

4 September 2018

Quick facts

Lead sponsor	AbbVie
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	20 November 2014
Primary completion	4 September 2018
Estimated completion	4 September 2018

Drugs / interventions tested

• Risankizumab (RISANKIZUMAB) — full drug profile →

Conditions studied

• Psoriasis — all drugs for Psoriasis →

Sponsor

AbbVie — full company profile →

Who can join

18 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Primary · From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacit

Group	Value	95% CI
Risankizumab 90 mg	67
Risankizumab 180 mg	18

Number of Participants With Drug-related TEAEs Primary · From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacit

Group	Value	95% CI
Risankizumab 90 mg	12
Risankizumab 180 mg	3

Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Primary · From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacit

Group	Value	95% CI
Risankizumab 90 mg	12
Risankizumab 180 mg	2

Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 48 in the Extended Dosing Period Primary · Baseline, Week 48

Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with t

Group	Value	95% CI
Risankizumab 18 mg/Risankizumab	72.7	54.1 – 91.3
Risankizumab 90 mg/Risankizumab	77.8	62.1 – 93.5
Risankizumab 180 mg/Risankizumab	71.9	56.3 – 87.5
Ustekinumab/Risankizumab	74.1	57.5 – 90.6

Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 48 of Extended Dosing Period Secondary · Week 48

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.

Group	Value	95% CI
Risankizumab 18 mg/Risankizumab	63.6	43.5 – 83.7
Risankizumab 90 mg/Risankizumab	70.4	53.1 – 87.6
Risankizumab 180 mg/Risankizumab	68.8	52.7 – 84.8
Ustekinumab/Risankizumab	66.7	48.9 – 84.4

Percentage of Participants Achieving 50% Improvement in PASI (PASI50) Score at Week 48 in the Extended Dosing Period Secondary · Baseline, Week 48

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. Baseline PAS

Group	Value	95% CI
Risankizumab 18 mg/Risankizumab	95.5	86.8 – 100.0
Risankizumab 90 mg/Risankizumab	96.3	89.2 – 100.0
Risankizumab 180 mg/Risankizumab	100.0	100.0 – 100.0
Ustekinumab/Risankizumab	100.0	100.0 – 100.0

Percentage of Participants Achieving 75% Improvement in PASI (PASI75) Score at Week 48 in the Extended Dosing Period Secondary · Baseline, Week 48

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. Baseline PAS

Group	Value	95% CI
Risankizumab 18 mg/Risankizumab	86.4	72.0 – 100.0
Risankizumab 90 mg/Risankizumab	92.6	82.7 – 100.0
Risankizumab 180 mg/Risankizumab	90.6	80.5 – 100.0
Ustekinumab/Risankizumab	96.3	89.2 – 100.0

Percentage of Participants Achieving 100% Improvement in PASI (PASI100) Score at Week 48 in the Extended Dosing Period Secondary · Baseline, Week 48

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for t

Group	Value	95% CI
Risankizumab 18 mg/Risankizumab	54.5	33.7 – 75.4
Risankizumab 90 mg/Risankizumab	55.6	36.8 – 74.3
Risankizumab 180 mg/Risankizumab	50.0	32.7 – 67.3
Ustekinumab/Risankizumab	55.6	36.8 – 74.3

Percentage of Participants Achieving sPGA of Clear at Week 48 of Extended Dosing Period Secondary · Week 48

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean \>0, \<1.5; Mild (2) = mean ≥1.5, \<2.5; Moderate (3) = mean ≥2.5, \<3.5; and Severe (4) = mean ≥3.5. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.

Group	Value	95% CI
Risankizumab 18 mg/Risankizumab	54.5	33.7 – 75.4
Risankizumab 90 mg/Risankizumab	63.0	44.7 – 81.2
Risankizumab 180 mg/Risankizumab	56.3	39.1 – 73.4
Ustekinumab/Risankizumab	55.6	36.8 – 74.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug in either the lead-in or extension study with an onset date within 105 days after the last dose of study drug or approximately 4 years from the first dose in either the lead-in or extension study.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Risankizumab 90 mg

Serious: 12/87 (14%)

Deaths: 0/87

Risankizumab 180 mg

Serious: 2/23 (9%)

Deaths: 0/23

Serious adverse events (23 terms)

Reaction	System	Risankizumab 90 mg	Risankizumab 180 mg
Transient ischaemic attack	Nervous system disorders	—	—
Myocardial infarction	Cardiac disorders	—	—
Goitre	Endocrine disorders	—	—
Glaucoma	Eye disorders	—	—
Macular degeneration	Eye disorders	—	—
Non-cardiac chest pain	General disorders	—	—
Cystitis	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Pyelonephritis	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Fall	Injury, poisoning and procedural complications	—	—
Lower limb fracture	Injury, poisoning and procedural complications	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Carpal tunnel syndrome	Nervous system disorders	—	—
Syncope	Nervous system disorders	—	—
Ulnar neuritis	Nervous system disorders	—	—
Psychotic disorder	Psychiatric disorders	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (13 terms — click to expand)

Reaction	System	Risankizumab 90 mg	Risankizumab 180 mg
Nasopharyngitis	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Tooth abscess	Infections and infestations	—	—
Hypertension	Vascular disorders	—	—
Bronchitis	Infections and infestations	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Sinusitis	Infections and infestations	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—
Muscle strain	Injury, poisoning and procedural complications	—	—
Dermal cyst	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Transient ischaemic attack, Myocardial infarction, Goitre, Glaucoma, Macular degeneration, Non-cardiac chest pain, Cystitis, Pneumonia.

Data from ClinicalTrials.gov NCT02203851 adverse events section.

Sponsor's own description

The primary objective of Study M16-009 was to investigate the safety of risankizumab in participants with moderate to severe chronic plaque psoriasis who were receiving long-term treatment. Additional study objectives were to further investigate the long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of risankizumab.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Risankizumab: Mechanism of action, clinical and translational science.
   Pang Y, D'Cunha R, Winzenborg I, Veldman G, et al · · 2024 · cited 26× · PMID 38266061 · DOI 10.1111/cts.13706
2. Old and new treatment targets in axial spondyloarthritis.
   Rios Rodriguez V, Poddubnyy D. · · 2015 · cited 8× · PMID 26557376 · DOI 10.1136/rmdopen-2015-000054
3. Long-Term Safety and Efficacy of Risankizumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: Results from a Phase 2 Open-Label Extension Trial.
   Papp KA, de Vente S, Zeng J, Flack M, et al · · 2021 · cited 7× · PMID 33512666 · DOI 10.1007/s13555-021-00490-3
4. Long-Term Safety and Efficacy of Risankizumab to Treat Moderate-to-Severe Plaque Psoriasis: Final LIMMitless Phase 3, Open-Label Extension Trial Results.
   Papp KA, Lebwohl MG, Puig L, Ohtsuki M, et al · · 2025 · cited 1× · PMID 40728772 · DOI 10.1007/s40257-025-00964-6