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CompletedNCT03384745Updated Aug 3, 2021Results posted

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

A Phase 2 interventional study of M1095 (Sonelokimab) and Placebo in Psoriasis, sponsored by Bond Avillion 2 Development LP. Completed at 60 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-03.

Sponsored by Bond Avillion 2 Development LP · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
313
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis

Browse trials for

03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's enrollment of 313 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Bond Avillion 2 Development LP is the lead sponsor of 6 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria (Main):

  1. Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (Psoriatic arthritis is allowed).
  2. 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 / .
  3. Laboratory abnormalities at screening, as defined in the study protocol.
  4. Prior use of systemic or topical treatments for psoriasis, as defined in the study protocol.
  5. Prior use of any compound targeting IL-17, more than two biologic therapies, ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.
  6. History of suicidal thoughts within 12 months.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
313 participants (actual)

Study arms

  • Experimental
    M1095 (Sonelokimab) 30mg

    M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

    Drug: M1095 (Sonelokimab)

  • Experimental
    M1095 (Sonelokimab) 60mg

    M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.

    Drug: M1095 (Sonelokimab)

  • Experimental
    M1095 (Sonelokimab) 120mg - regimen 1

    M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.

    Drug: M1095 (Sonelokimab)

  • Experimental
    M1095 (Sonelokimab) 120mg - regimen 2

    M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.

    Drug: M1095 (Sonelokimab)

  • Placebo comparator
    Placebo / M1095 (Sonelokimab) 120mg

    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.

    Drug: M1095 (Sonelokimab) · Drug: Placebo

  • Active comparator
    Secukinumab

    Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks.

    Drug: Secukinumab

Interventions

  • DrugM1095 (Sonelokimab)

    M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.

    Also known as: Sonelokimab

  • DrugPlacebo

    Placebo contains no active drug.

  • DrugSecukinumab

    Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.

    Also known as: Cosentyx®

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 12, as compared to Week 0 (baseline)

Secondary outcomes

  1. 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.

    Time frame: Week 12, as compared to Week 0 (baseline)

  2. 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

    Time frame: Week 12, as compared to baseline

  3. 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

    Time frame: Week 12, as compared to Week 0 (baseline)

07

Results

Posted Aug 2, 2021

Participant flow

Subjects were adults aged 18-75 years with stable, moderate to severe plaque type psoriasis for \>6 months prior to randomisation, and who were candidates for systemic biologic therapy.

Placebo Controlled Induction (W0 - W12)
Participant flow — Placebo Controlled Induction (W0 - W12)
MilestoneM1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumab
Started525253515253
Completed525150494951
Not completed013232
Withdrew: Adverse event001200
Withdrew: Withdrawal by subject000031
Withdrew: Lost to follow-up011001
Withdrew: Protocol violation001000
Maintenance/Escalation (W12-W24)
Participant flow — Maintenance/Escalation (W12-W24)
MilestoneM1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumab
Started525150494951
Completed525149474751
Not completed001220
Withdrew: Adverse event000110
Withdrew: Withdrawal by subject000010
Withdrew: Lack of efficacy001100
Response Assess/Dose Hold (W24-W48)
Participant flow — Response Assess/Dose Hold (W24-W48)
MilestoneM1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumab
Started525149474751
Completed514845434649
Not completed134412
Withdrew: Adverse event113010
Withdrew: Withdrawal by subject011202
Withdrew: Lost to follow-up000200
Withdrew: Death010000

Outcome measures

PrimaryNumber 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.

Time frame:
Week 12, as compared to Week 0 (baseline)
Reported as:
Count of participants · Participants
Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1
ParticipantsM1095 30mgM1095 60mgM1095 120mg - Normal Load GroupM1095 120mg - Augmented Load GroupPlaceboSecukinumab
Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 125444145041
Statistical analysis
  • M1095 30mg vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001
  • M1095 60mg vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001
  • M1095 120mg - Normal Load Group vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001
  • M1095 120mg - Augmented Load Group vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001
  • Placebo vs Secukinumab · Cochran-Mantel-Haenszel · p = <0.0001
SecondaryNumber 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.

Time frame:
Week 12, as compared to Week 0 (baseline)
Reported as:
Count of participants · Participants
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)
ParticipantsM1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumab
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)9132017015
SecondaryNumber 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

Time frame:
Week 12, as compared to baseline
Reported as:
Count of participants · Participants
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)
ParticipantsM1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumab
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)19343739034
SecondaryNumber 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

Time frame:
Week 12, as compared to Week 0 (baseline)
Reported as:
Count of participants · Participants
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)
ParticipantsM1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumab
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)34464546048

Adverse events

Collected over 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).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo (Week 0 to Week 12)0/52 (0%)1/52 (1.9%)11/52 (21.2%)
M1095 30mg (Week 0 to Week 12)0/52 (0%)2/52 (3.8%)13/52 (25%)
M1095 60 mg (Week 0 to Week 12)0/52 (0%)1/52 (1.9%)16/52 (30.8%)
M1095 120mg - Normal Load Group (Week 0 to Week 12)0/53 (0%)1/53 (1.9%)18/53 (34%)
M1095 120mg - Augmented Load Group (Week 0 to Week 12)0/51 (0%)1/51 (2%)15/51 (29.4%)
Secukinumab (Week 0 to Week 12)0/53 (0%)0/53 (0%)14/53 (26.4%)
M1095 - All Participants (Week 0 to Week 12 )0/208 (0%)5/208 (2.4%)62/208 (29.8%)
M1095 - All Participants (Week 12 to Week 52)1/251 (0.4%)12/251 (4.8%)57/251 (22.7%)
Secukinumab (Week 12 to Week 52)0/51 (0%)2/51 (3.9%)16/51 (31.4%)
Most frequent serious events
Showing 10 of 21
Most frequent serious events
EventPlacebo (Week 0 to Week 12)M1095 30mg (Week 0 to Week 12)M1095 60 mg (Week 0 to Week 12)M1095 120mg - Normal Load Group (Week 0 to Week 12)M1095 120mg - Augmented Load Group (Week 0 to Week 12)Secukinumab (Week 0 to Week 12)M1095 - All Participants (Week 0 to Week 12 )M1095 - All Participants (Week 12 to Week 52)Secukinumab (Week 12 to Week 52)
Acute kidney injuryRenal and urinary disorders0/520/520/520/531/510/531/2080/2510/51
Infectious pleural effusionInfections and infestations0/520/520/520/530/510/530/2080/2511/51
Oesophageal candidiasisInfections and infestations0/520/520/520/530/510/530/2080/2511/51
PneumoniaInfections and infestations0/520/520/520/531/510/531/2080/2511/51
Forearm fractureInjury, poisoning and procedural complications0/520/521/520/530/510/531/2080/2510/51
Upper limb fractureInjury, poisoning and procedural complications0/521/520/520/530/510/531/2080/2510/51
PneumonitisRespiratory, thoracic and mediastinal disorders0/521/520/520/530/510/531/2080/2510/51
HypertensionVascular disorders1/520/520/520/530/510/530/2080/2510/51
Renal colicRenal and urinary disorders0/520/520/521/530/510/531/2080/2510/51
Atrial fibrillationCardiac disorders0/520/520/520/530/510/530/2082/2510/51
Most frequent other events
Most frequent other events
EventPlacebo (Week 0 to Week 12)M1095 30mg (Week 0 to Week 12)M1095 60 mg (Week 0 to Week 12)M1095 120mg - Normal Load Group (Week 0 to Week 12)M1095 120mg - Augmented Load Group (Week 0 to Week 12)Secukinumab (Week 0 to Week 12)M1095 - All Participants (Week 0 to Week 12 )M1095 - All Participants (Week 12 to Week 52)Secukinumab (Week 12 to Week 52)
NasopharyngitisInfections and infestations4/524/5211/529/534/516/5328/20826/2517/51
PruritusSkin and subcutaneous tissue disorders2/523/524/523/534/511/5314/2086/2511/51
Upper respiratory tract infectionInfections and infestations1/521/523/523/532/513/539/20812/2513/51
Oral candidiasisInfections and infestations0/520/521/522/533/510/536/20813/2510/51
HeadacheNervous system disorders1/520/523/523/531/513/537/2083/2511/51
ArthralgiaMusculoskeletal and connective tissue disorders1/523/520/521/532/510/536/2085/2512/51
HypertensionVascular disorders2/523/521/520/532/511/536/2085/2512/51

Baseline characteristics

Age, Continuous
Age, Continuous(years)M1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumabTotal
Mean48.2 ± 13.446.9 ± 12.344.1 ± 13.143.2 ± 13.245.9 ± 12.947.5 ± 13.846.0 ± 13.1
Sex: Female, Male
Sex: Female, Male(Participants)M1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumabTotal
Female363843343938228
Male16141017131585
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)M1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumabTotal
Hispanic or Latino43321215
Not Hispanic or Latino484950495151298
Unknown or Not Reported0000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)M1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumabTotal
American Indian or Alaska Native0100001
Asian21826322
Native Hawaiian or Other Pacific Islander0000000
Black or African American0102216
White494845474449282
More than one race0000000
Unknown or Not Reported1100002
Region of Enrollment
Region of Enrollment(participants)M1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumabTotal
Canada79119121159
Hungary68645433
United States107653536
Czechia1314138161680
Poland8871351051
Bulgaria748109543
Germany12222211
Height (cm)
Height (cm)(centimetres)M1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumabTotal
Mean173 ± 10.4173 ± 9.60174 ± 9.89173 ± 11.2173 ± 10.1172 ± 9.98173 ± 10.2
Weight at baseline (kg)
Weight at baseline (kg)(kilograms)M1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumabTotal
Mean92.0 ± 19.091.5 ± 20.689.0 ± 18.393.0 ± 22.691.3 ± 24.190.3 ± 22.491.2 ± 21.1
Prior biological use (actual)
Prior biological use (actual)(Participants)M1095 30mgM1095 60mgM1095 120mg - Regimen 1M1095 120mg - Regimen 2Placebo / M1095 120mgSecukinumabTotal
Yes910978750
No434244444446263

5 further baseline measures are reported on the registry.

08

Study locations

60 sites
  • Investigative Site
    Birmingham, Alabama 35205, United States
  • Investigative Site
    San Diego, California 92123, United States
  • Investigative Site
    DeLand, Florida 32720, United States
  • Investigative Site
    Sandy Springs, Georgia 30328, United States
  • Investigative Site
    Saint Louis, Missouri 63117, United States
  • Investigative Site
    Albuquerque, New Mexico 87102, United States
  • Investigative Site
    New York, New York 10029, United States
  • Investigative Site
    Bexley, Ohio 43209, United States
  • Investigative Site
    Dallas, Texas 75246, United States
  • Investigative Site
    Houston, Texas 77004, United States
  • Investigative Site
    San Antonio, Texas 78229, United States
  • Investigative Site
    Dupnitsa, 2600, Bulgaria
  • Investigative Site
    Sofia, 1431, Bulgaria
  • Investigative Site
    Varna, 9010, Bulgaria
  • Investigative Site
    Edmonton, Alberta T5K 1X3, Canada
  • Investigative Site
    Surrey, British Columbia V3R 6A7, Canada
  • Investigative Site
    Surrey, British Columbia V3V 0C6, Canada
  • Investigative Site
    Markham, Ontario L3P 1X2, Canada
  • Investigative Site
    North Bay, Ontario P1B 3Z7, Canada
  • Investigative Site
    Oakville, Ontario L6J 7W5, Canada
  • Investigative Site
    Ottawa, Ontario K2G 6E2, Canada
  • Investigative Site
    Richmond Hill, Ontario L4B 1A5, Canada
  • Investigative Site
    Waterloo, Ontario N2J 1C4, Canada
  • Investigative Site
    Windsor, Ontario N8W 1E6, Canada
  • Investigative Site
    Quebec City, Quebec G1V 4X7, Canada
  • Investigative Site
    Brno, 602 00, Czechia
  • Investigative Site
    Nový Jičín, 741 01, Czechia
  • Investigative Site
    Náchod, 547 01, Czechia
  • Investigative Site
    Ostrava, 702 00, Czechia
  • Investigative Site
    Ostrava, 708 52, Czechia
  • Investigative Site
    Pardubice, 530 02, Czechia
  • Investigative Site
    Praha, 130 00, Czechia
  • Investigative Site
    Uherské Hradiště, 686 01, Czechia
  • Investigative Site
    Augsburg, 86179, Germany
  • Investigative Site
    Berlin, 10789, Germany
  • Investigative Site
    Bochum, 44793, Germany
  • Investigative Site
    Darmstadt, 64297, Germany
  • Investigative Site
    Frankfurt/Main, 60590, Germany
  • Investigative Site
    Friedrichshafen, 88045, Germany
  • Investigative Site
    Hamburg, 20354, Germany
  • Investigative Site
    Kiel, 24105, Germany
  • Investigative Site
    Mahlow, 15831, Germany
  • Investigative Site
    Mainz, 55131, Germany
  • Investigative Site
    Osnabrück, 49074, Germany
  • Investigative Site
    Quedlinburg, 06484, Germany
  • Investigative Site
    Schwerin, 19055, Germany
  • Investigative Site
    Budapest, 1085, Hungary
  • Investigative Site
    Budapest, 1135, Hungary
  • Investigative Site
    Kecskemét, 6000, Hungary
  • Investigative Site
    Orosháza, 5900, Hungary
  • Investigative Site
    Szeged, 6720, Hungary
  • Investigative Site
    Szolnok, 5000, Hungary
  • Investigative Site
    Katowice, 40-060, Poland
  • Investigative Site
    Lublin, 20-314, Poland
  • Investigative Site
    Poznań, 60-848, Poland
  • Investigative Site
    Siedlce, 08-110, Poland
  • Investigative Site
    Skierniewice, 96-100, Poland
  • Investigative Site
    Warszawa, 02-507, Poland
  • Investigative Site
    Warszawa, 02-777, Poland
  • Investigative Site
    Warszawa, 04-141, Poland
09

References and documents

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. Erratum In: Lancet. 2021 Jun 5;397(10290):2150. doi: 10.1016/S0140-6736(21)01068-0. PubMed 33894834 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Jun 2019, 10 months.

Results were first posted in Aug 2021, 2 years 1 month after primary completion.

Of 145 industry-sponsored phase 2 interventional studies under Psoriasis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 20. This study's 10 months is below that.

Counting every sponsor, half of 174 studies reached it within 14 months; a quarter within 9 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2017
First posted
Dec 27, 2017
StartActual
Jul 31, 2018
Primary completionActual
Jun 20, 2019
CompletionActual
Mar 26, 2020
Results first posted
Aug 2, 2021
Last update
Aug 3, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03384745
Lead sponsor
Bond Avillion 2 Development LP
Collaborators
Avillion LLP
Responsible party
Sponsor
First posted
Dec 27, 2017
Start date
Jul 31, 2018
Primary completion
Jun 20, 2019
Completion
Mar 26, 2020
Results posted
Aug 2, 2021
Last update
Aug 3, 2021

Study contacts

Dr. Kim Papp
principal investigator · Probity Medical Research Inc

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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