ClinicalTrials.gg
Not yet recruitingNCT07933536Updated Nov 12, 2026

A Study to Assess Targeted Therapies for Treatment of Adults With Moderate to Severe Psoriasis

A Phase 2 interventional study of Risankizumab and ABBV-295 in Moderate to Severe Psoriasis, sponsored by AbbVie. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by AbbVie · Phase 2, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 79 studies in Psoriasis by AbbVie — 2 open to participants now, 6 under way, 1 of them phase 3. Psoriasis · AbbVie.

Planned enrollment
36th of 48
105 · median 166
Started
2026
the only one that year
Phase 2
5 of 79
1 open now
Registered
79th of 79
by date

Among the 79 studies in Psoriasis by AbbVie, this one is the 36th largest by planned enrollment of the 48 interventional ones that give a count, is the only one that started in 2026, is one of 5 in phase 2, and was the 79th registered.

Psoriasis

2,030 studies on the registry are indexed under Psoriasis; 277 are open to participants now.

Browse Psoriasis studies →

Open to participants now

2 of the 79 studies in Psoriasis by AbbVie are open now, in 8 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Who these studies take

Of the 174 Psoriasis studies recruiting now, 91 (52%) set no upper age limit and 67 (39%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 79 studies in Psoriasis by AbbVie, or all of them as a file.
02

Study summary

Psoriasis is a long-term skin disease that causes inflammation, thick skin, and scaly patches on the skin. This study evaluates the safety and effectiveness of risankizumab in combination with ABBV-295 compared with risankizumab alone in adult participants with moderate to severe psoriasis.

Risankizumab is an approved drug for the treatment of moderate to severe psoriasis. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Participants will receive either risankizumab plus ABBV-295 or risankizumab plus ABBV-295 matching placebo. Around 105 adult participants with moderate to severe psoriasis will be enrolled in the study at approximately 50 sites worldwide.

Participants will receive injections of risankizumab and ABBV-295 or risankizumab and ABBV-295 matching placebo for up to 52 weeks, with a 20-week follow-up period after the last dose of the study.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

03

Conditions studied

  • Moderate to Severe Psoriasis

Browse trials for

Keywords

  • Psoriasis
  • Moderate to Severe Psoriasis
  • Risankizumab
  • ABBV-295
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

  • Clinical diagnosis of chronic plaque psoriasis (PsO) with or without psoriatic arthritis for at least 6 months before the Baseline Visit
  • Stable moderate to severe chronic plaque psoriasis with or without Psoriatic arthritis (PsA) at both Screening and Baseline Visit defined as follows: ≥ 10% Body Surface Area psoriasis involvement, Static Physician's Global Assessment score of ≥ 3, and PASI score ≥ 12
  • Candidates for systemic therapy or phototherapy as assessed by the investigator.

Exclusion criteria

Exclusion Criteria:

  • Participants with any form of PsO other than chronic plaque PsO (e.g., pustular PsO, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic, or guttate PsO).
  • Participants with a history of current drug-induced PsO or a drug-induced exacerbation of pre-existing PsO.
  • Participants with a history of active ongoing inflammatory skin diseases other than PsO (with or without PsA) that could interfere with the assessment of PsO (e.g., hyperkeratotic eczema).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    Risankizumab and ABBV-295 Combination Therapy

    Participants will receive risankizumab in combinations with ABBV-295 for up to 52 weeks.

    Drug: Risankizumab · Drug: ABBV-295

  • Active comparator
    Risankizumab and ABBV-295 Matching Placebo

    Participants will receive risankizumab with ABBV-295 matching placebo for up to 52 weeks.

    Drug: Risankizumab · Drug: ABBV-295 Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving at least a 90% reduction from Baseline in Psoriasis Area and Severity Index (PASI 90)

    PASI is a measure of psoriatic disease severity taking into account the overall severity of erythema, induration and scaling, and the extent of affected area in each of four anatomical regions (head, trunk, upper extremities, and lower extremities). PASI scores range from 0 (no psoriasis) to 72 (severe disease over the entire body surface). Higher scores indicate worse disease severity. PASI 90 indicates at least 90% improvement from baseline.

    Time frame: Week 28

  2. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Time frame: Up to 72 Weeks

Secondary outcomes

  1. Percentage of Participants Achieving 100% Reduction from Baseline in PASI 100

    PASI is a measure of psoriatic disease severity taking into account the overall severity of erythema, induration and scaling, and the extent of affected area in each of four anatomical regions (head, trunk, upper extremities, and lower extremities). PASI scores range from 0 (no psoriasis) to 72 (severe disease over the entire body surface). Higher scores indicate worse disease severity. PASI 100 indicates at least 100% improvement from baseline.

    Time frame: Week 28

  2. Percentage of Participants Achieving ≥10% Body Weight Reduction from Baseline

    Achievement of at least 10% body weight reduction from Baseline.

    Time frame: Week 28

  3. Percent Change from Baseline in Body Weight

    Percent change from Baseline in body weight.

    Time frame: Week 28

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Supporting information: Study protocol, Statistical analysis plan

Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

1 registry update 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

Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.

Of 146 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 planned 24 months is above that.

Counting every sponsor, half of 175 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
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Dec 3, 2026
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Nov 12, 2026
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.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07933536
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Dec 3, 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: ABBV-295

Start the discussion