PsoriasisPhase 2NCT03384745

A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis

A Phase 2 study testing M1095 (Sonelokimab) and Secukinumab in people with Psoriasis, run by Bond Avillion 2 Development LP at 60 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites in North America and Europe. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Psoriasis
What is being tested?: M1095 (Sonelokimab) and Secukinumab
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 313 participants
Where: 60 sitesin 7 countries
Study dates: 31 Jul 2018to 26 Mar 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female subjects between 18 and 75 years of age.
Moderate to severe plaque-type psoriasis for at least 6 months.
Subject is a candidate for systemic biologic therapy.
Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline.
Subject is able to comply with the study procedures.
Subject must provide informed consent.

Who cannot join

Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed).
Other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. Subjects will be screened for tuberculosis and hepatitis B / hepatitis C.
Laboratory abnormalities at screening, as defined in the study protocol.
Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.
Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.
History of suicidal thoughts within 12 months.

Trial locations and contacts

60 sites in 7 countries.

Country

City, postcode or hospital

60 sites in 7 countries

Germany13 sites

Investigative Site
Augsburg, 86179
Investigative Site
Berlin, 10789
Investigative Site
Bochum, 44793
Investigative Site
Darmstadt, 64297
Investigative Site
Frankfurt am Main, 60590
Investigative Site
Friedrichshafen, 88045
Investigative Site
Hamburg, 20354
Investigative Site
Kiel, 24105
Investigative Site
Mahlow, 15831
Investigative Site
Mainz, 55131
Investigative Site
Osnabrück, 49074
Investigative Site
Quedlinburg, 06484
Investigative Site
Schwerin, 19055

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United States11 sites

Investigative Site
Albuquerque, New Mexico, 87102
Investigative Site
Bexley, Ohio, 43209
Investigative Site
Birmingham, Alabama, 35205
Investigative Site
Dallas, Texas, 75246
Investigative Site
DeLand, Florida, 32720
Investigative Site
Houston, Texas, 77004
Investigative Site
New York, New York, 10029
Investigative Site
San Antonio, Texas, 78229
Investigative Site
San Diego, California, 92123
Investigative Site
Sandy Springs, Georgia, 30328
Investigative Site
St Louis, Missouri, 63117

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Canada11 sites

Investigative Site
Edmonton, Alberta, T5K 1X3
Investigative Site
Markham, Ontario, L3P 1X2
Investigative Site
North Bay, Ontario, P1B 3Z7
Investigative Site
Oakville, Ontario, L6J 7W5
Investigative Site
Ottawa, Ontario, K2G 6E2
Investigative Site
Québec, Quebec, G1V 4X7
Investigative Site
Richmond Hill, Ontario, L4B 1A5
Investigative Site
Surrey, British Columbia, V3R 6A7
Investigative Site
Surrey, British Columbia, V3V 0C6
Investigative Site
Waterloo, Ontario, N2J 1C4
Investigative Site
Windsor, Ontario, N8W 1E6

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Czechia8 sites

Investigative Site
Brno, 602 00
Investigative Site
Náchod, 547 01
Investigative Site
Nový Jičín, 741 01
Investigative Site
Ostrava, 702 00
Investigative Site
Ostrava, 708 52
Investigative Site
Pardubice, 530 02
Investigative Site
Prague, 130 00
Investigative Site
Uherské Hradiště, 686 01

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Poland8 sites

Investigative Site
Katowice, 40-060
Investigative Site
Lublin, 20-314
Investigative Site
Poznan, 60-848
Investigative Site
Siedlce, 08-110
Investigative Site
Skierniewice, 96-100
Investigative Site
Warsaw, 02-507
Investigative Site
Warsaw, 02-777
Investigative Site
Warsaw, 04-141

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Hungary6 sites

Investigative Site
Budapest, 1085
Investigative Site
Budapest, 1135
Investigative Site
Kecskemét, 6000
Investigative Site
Orosháza, 5900
Investigative Site
Szeged, 6720
Investigative Site
Szolnok, 5000

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Bulgaria3 sites

Investigative Site
Dupnitsa, 2600
Investigative Site
Sofia, 1431
Investigative Site
Varna, 9010

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About this study

Official title: A Phase 2b Randomized, Double-blind, Placebo Controlled, Multi-center 12-week Study With an Additional 40-week Follow-up Assessment of Efficacy, Safety and Tolerability of M1095 in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Conditions: Psoriasis
Being tested: M1095 (Sonelokimab), Placebo, Secukinumab
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

M1095 (Sonelokimab)Drug
Also called Sonelokimab
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
PlaceboDrug
Placebo contains no active drug.
SecukinumabDrug
Also called Cosentyx®
Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.

Study groups in NCT03384745
Study group	Role	What they receive
M1095 (Sonelokimab) 30mg	Experimental	M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. Receives: Drug: M1095 (Sonelokimab)
M1095 (Sonelokimab) 60mg	Experimental	M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. Receives: Drug: M1095 (Sonelokimab)
M1095 (Sonelokimab) 120mg - regimen 1	Experimental	M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks. Receives: Drug: M1095 (Sonelokimab)
M1095 (Sonelokimab) 120mg - regimen 2	Experimental	M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks. Receives: Drug: M1095 (Sonelokimab)
Placebo / M1095 (Sonelokimab) 120mg	Placebo comparator	Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks. Receives: Drug: M1095 (Sonelokimab); Drug: Placebo
Secukinumab	Active comparator	Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks. Receives: Drug: Secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1
The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.
Measured: Week 12, as compared to Week 0 (baseline)

Secondary outcomes (3)

Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)
PASI 100, i.e. a subject's psoriasis has completely cleared at Week 12, compared to baseline.
Measured: Week 12, as compared to Week 0 (baseline)
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)
PASI 90, i.e. a subject's psoriasis has cleared by 90% at Week 12, compared to baseline
Measured: Week 12, as compared to baseline
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)
PASI 75, i.e. a subject's psoriasis has cleared by 75% at Week 12, compared to baseline
Measured: Week 12, as compared to Week 0 (baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 201826 Mar 2020

First posted27 Dec 2017
Study start31 Jul 2018
Primary completion20 Jun 2019
Study completion26 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 313 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03384745
Sponsor's protocol ID: AV002
Status last verified: Aug 2021
First submitted: 20 Dec 2017
Last updated: 3 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Papp KA, Weinberg MA, Morris A, Reich K. IL17A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase 2b study. Lancet. 2021 Apr 24;397(10284):1564-1575. doi: 10.1016/S0140-6736(21)00440-2.
PubMed 33894834

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b Randomized, Double-blind, Placebo Controlled, Multi-center 12-week Study With an Additional 40-week Follow-up Assessment of Efficacy, Safety and Tolerability of M1095 in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
ClinicalTrials.gov ID: NCT03384745
Acronym / sponsor ID: AV002
Conditions: Psoriasis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 313 participants (actual)
Lead sponsor: Bond Avillion 2 Development LPIndustry (pharma, biotech, devices)
Collaborators: Avillion LLP
Study start: 31 Jul 2018 (actual)
Primary completion: 20 Jun 2019 (actual)
Study completion: 26 Mar 2020 (actual)
First posted: 27 Dec 2017 (actual)
Results: Posted 2 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
M1095 (Sonelokimab) 30mg	Experimental	Drug: M1095 (Sonelokimab)M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
M1095 (Sonelokimab) 60mg	Experimental	Drug: M1095 (Sonelokimab)M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.
M1095 (Sonelokimab) 120mg - regimen 1	Experimental	Drug: M1095 (Sonelokimab)M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.
M1095 (Sonelokimab) 120mg - regimen 2	Experimental	Drug: M1095 (Sonelokimab)M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.
Placebo / M1095 (Sonelokimab) 120mg	Placebo comparator	Drug: M1095 (Sonelokimab), Drug: PlaceboPlacebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks.
Secukinumab	Active comparator	Drug: SecukinumabSecukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male and female subjects between 18 and 75 years of age.
Moderate to severe plaque-type psoriasis for at least 6 months.
Subject is a candidate for systemic biologic therapy.
Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening and at baseline.
Subject is able to comply with the study procedures.

Key exclusion criteria (6 listed)

Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed).
Other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. Subjects will be screened for tuberculosis and hepatitis B / hepatitis C.
Laboratory abnormalities at screening, as defined in the study protocol.
Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.
Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
M1095 (Sonelokimab)Also: SonelokimabM1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	Drug	M1095 (Sonelokimab) 120mg - regimen 1, M1095 (Sonelokimab) 120mg - regimen 2, M1095 (Sonelokimab) 30mg, M1095 (Sonelokimab) 60mg, Placebo / M1095 (Sonelokimab) 120mg
PlaceboPlacebo contains no active drug.	Drug	Placebo / M1095 (Sonelokimab) 120mg
SecukinumabAlso: Cosentyx®Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.	Drug	Secukinumab

Primary outcome

Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1
Time frame: Week 12, as compared to Week 0 (baseline)
The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.

3 secondary outcomes

Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)
Time frame: Week 12, as compared to Week 0 (baseline)
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)
Time frame: Week 12, as compared to baseline
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)
Time frame: Week 12, as compared to Week 0 (baseline)

Results and safety

Results posted to the registry on 2 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
M1095 30mg	52	52
M1095 60mg	52	51
M1095 120mg - Regimen 1	53	50
M1095 120mg - Regimen 2	51	49
Placebo / M1095 120mg	52	49
Secukinumab	53	51

Primary outcome: Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1

Time frame: Week 12, as compared to Week 0 (baseline). Count of participants. Unit: Participants

Measure	M1095 30mg n = 52	M1095 60mg n = 52	M1095 120mg - Normal Load Group n = 53	M1095 120mg - Augmented Load Group n = 51	Placebo n = 52	Secukinumab n = 53
Value	25	44	41	45	0	41

M1095 30mg vs Placebo: p <0.0001, Cochran-Mantel-Haenszel
M1095 60mg vs Placebo: p <0.0001, Cochran-Mantel-Haenszel
M1095 120mg - Normal Load Group vs Placebo: p <0.0001, Cochran-Mantel-Haenszel

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the signing of the informed consent form i.e. the start of the screening period (Week -4) through to the end of the study (Week 52).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Week 0 to Week 12)	1 of 52 (1.9%)	11 of 52 (21.2%)	0 of 52
M1095 30mg (Week 0 to Week 12)	2 of 52 (3.8%)	13 of 52 (25%)	0 of 52
M1095 60 mg (Week 0 to Week 12)	1 of 52 (1.9%)	16 of 52 (30.8%)	0 of 52
M1095 120mg - Normal Load Group (Week 0 to Week 12)	1 of 53 (1.9%)	18 of 53 (34%)	0 of 53
M1095 120mg - Augmented Load Group (Week 0 to Week 12)	1 of 51 (2%)	15 of 51 (29.4%)	0 of 51
Secukinumab (Week 0 to Week 12)	0 of 53 (0%)	14 of 53 (26.4%)	0 of 53
M1095 - All Participants (Week 0 to Week 12 )	5 of 208 (2.4%)	62 of 208 (29.8%)	0 of 208
M1095 - All Participants (Week 12 to Week 52)	12 of 251 (4.8%)	57 of 251 (22.7%)	1 of 251
Secukinumab (Week 12 to Week 52)	2 of 51 (3.9%)	16 of 51 (31.4%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33894834Papp KA, Weinberg MA, Morris A, Reich K. IL17A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase 2b study. Lancet. 2021 Apr 24;397(10284):1564-1575. doi: 10.1016/S0140-6736(21)00440-2.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
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Recruiting
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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. Kim Papp principal investigator

Probity Medical Research Inc

60 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing M1095 (Sonelokimab) and Secukinumab in people with Psoriasis, run by Bond Avillion 2 Development LP at 60 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Germany, United States, Canada, Czechia, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 (time frame: Week 12, as compared to Week 0 (baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03384745, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.