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PsoriasisPhase 1/2NCT05725057

Proof of Concept Study of AX-158 in Patients With Mild to Moderate Plaque Psoriasis

A Phase 1/2 study testing AX-158 in people with Psoriasis and Plaque Psoriasis, run by Artax Biopharma Inc at 6 sites in United Kingdom.

Completed

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

Official record
Search all trials

Trial summary

Proof of concept study to assess the safety and tolerability of AX-158 in patients with mild to moderate psoriasis. Patients will be evaluated for a 28-day treatment period with either AX-158 or Placebo and then followed for an additional 30 days for safety. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Psoriasis, Plaque Psoriasis
What is being tested?
AX-158
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
6 sitesUnited Kingdom
Study dates
30 Nov 2023to 4 Oct 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions.
  • Diagnosis of plaque psoriasis for ≥3 months at time of screening.
  • Male or female subjects age 18 to 60 years, inclusive, at the time of informed consent.
  • Body mass index (BMI) 18 to 40 kg/m2, inclusive, where BMI (kg/m2) is calculated by body weight (kg)/height2 (m2).
  • Female subjects may be enroled if the following criteria are met:
  • Documented to be surgically sterile or postmenopausal or practicing true abstinence for at least 28 days prior to investigational product (IP) administration until 30 days (duration of ovulatory cycle) after the last IP administration and having a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to the start of IP administration, or
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  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to the start of IP administration.
  • WOCBP must agree to follow instructions for methods of contraception as described in Appendix 18.2 for the duration of treatment with IP plus 5 half-lives of IP (50 hours) plus 30 days (duration of ovulatory cycle) after the last IP administration.
  • Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the study period.
  • Male subjects who are sexually active with WOCBP may be enrolled if they are
  • Documented to be surgically sterile (vasectomy), or
  • Practicing true abstinence for 90 days after the last IP administration, or
  • Males who are sexually active with WOCBP must agree to follow instructions for methods of contraception for the duration of treatment with IP plus 5 half-lives of the IP plus 90 days (duration of sperm turnover) after the last IP administration. In addition, male subjects must be willing to refrain from sperm donation during this time.
  • Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements and must still undergo pregnancy testing as described in inclusion criterion #6b.
  • Fully vaccinated for COVID-19 per local regulations and site standard of care (SOC).

Who cannot join

  • Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic).
  • Diagnosis of psoriatic arthritis, uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with psoriasis for which a subject requires current systemic (oral, subcutaneous, or intravenous [IV]) (including corticosteroids, immunosuppressants, biologics) immunosuppressant medical treatment. Certain therapies such as non-steroidal anti-inflammatory drugs may be permitted at the discretion of the medical monitor.
  • Psoriasis affecting the scalp only.
  • Inability to tolerate oral medication.
  • A clinically significant history of gastrointestinal disorder likely to influence absorption of IP.
  • Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction.
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  • Participation in a clinical study and/or receipt of an IP within the previous 3 months or 5 half-lives, whichever is longer, before administration of the first dose of IP.
  • History or evidence of active infection and/or febrile illness within 7 days of first administration of IP.
  • History of serious bacterial, fungal, or viral infections that required hospitalization and IV antibiotic treatment within 90 days prior to screening, or any recent serious infection requiring antibiotic treatment within 30 days of IP administration.
  • Has received a live vaccine within 60 days of first dose of IP.
  • Current clinical radiographic or laboratory evidence of active tuberculosis (TB), or any history of or significant risk for TB.
  • Any major surgery within 4 weeks of IP administration.
  • Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac hospitalization within the last 3 months.
  • History of malignancy (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence).
  • Has used topical medications/treatments that could affect psoriasis or sPGA evaluation (including, but not limited to, mild to moderate corticosteroids [eg, hydrocortisone cream, triamcinolone acetonide], calcineurin inhibitor, calcipotriol, salicylic acid/other keratolytic, coal tar, short contact dithranol) within 4 weeks of the first administration of IP.
  • Has received phototherapy that could affect psoriasis or sPGA evaluation (eg, narrowband ultraviolet B [UVB] psoralen [oral or topical] with local UVA) within 4 weeks of the first administration of IP.
  • Has received any systemic non-biologic medications/treatments (including, but not limited to, methotrexate, ciclosporin, acitretin, and apremilast) or any systemic biologic medications/treatments (including, but not limited to etanercept, efalizumab, infliximab, adalimumab, ustekinumab, secukinumab, and ixekizumab) that could affect psoriasis or sPGA evaluation within 4 weeks of the first administration of the IP.
  • Chest X-ray findings suspicious of infection at screening. Subjects may be rescreened and if deemed eligible may be randomized within 28 days of completing an appropriate course of antibiotic treatment for pulmonary infection. If a chest X-ray has been performed within 6 months of the screening visit and the report and results are available, then a chest X-ray is not required at the screening visit.
  • Clinically significant history of previous allergy and/or sensitivity to AX-158 or any of the excipients contained within AX-158.
  • Clinically significant abnormal test results for serum biochemistry, hematology, and/or urine analyses within 28 days prior to first dose administration of the IP:
  • Leukopenia defined as absolute white blood cell count <3000/mm3 within 28 days of dosing with IP on Day 1.
  • Lymphopenia defined as absolute lymphocyte count <500/mm3 within 28 days of dosing with IP on Day 1.
  • Neutropenia defined as absolute neutrophil count <1000/mm3 within 28 days of dosing with IP on Day 1.
  • Moderate to severe thrombocytopenia defined as platelet count <100,000/mm3 within 28 days of dosing with IP on Day 1.
  • Moderate to severe anemia defined as hemoglobin <9 g/dL within 28 days of dosing with IP on Day 1.
  • Total serum bilirubin, alkaline phosphatase, aspartate transaminase and alanine transaminase >1.5 × upper limit of normal (ULN). If total bilirubin is above the ULN and is then fractionated, direct bilirubin must be within normal limits.
  • Subject with a positive urinary drug screen (including alcohol and cotinine) test results, determined within 28 days before the first dose administration of the IP. A positive test result may be repeated at the investigator's discretion.
  • Clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 28 days before first dose of IP including a QRS >120 ms, PR interval >220 ms and QT interval corrected using Fredericia's formula >450 ms.
  • Clinically significant abnormalities in vital signs and physical examination determined within 28 days before first dose of IP.
  • Subjects with a positive COVID-19 test on admission per local regulations and site SOC.
  • Any other condition that, in the investigator's judgement, will substantially increase the risk to the subject if they participate in the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United Kingdom6 sites

  • Accellacare Northamptonshire

    Corby

  • Accellacare Warwickshire

    Coventry

  • MEU

    Manchester

  • Accellacare North London

    Northwood

  • Accellacare South London

    Orpington

  • Accellacare Yorkshire

    Shipley

Other trials in United Kingdom

About this study

Official title: A Phase 2a, Proof of Concept Study Evaluating the Safety and Tolerability of AX-158 in Patients With Mild to Moderate Plaque Psoriasis

Proof of concept study to assess the safety and tolerability of AX-158 in patients with mild to moderate psoriasis. Patients will be evaluated for a 28-day treatment period with either AX-158 or Placebo and then followed for an additional 30 days for safety.

Read the detailed description

This is a Phase 2a Proof of Concept randomized, double-blind, placebo-controlled study to investigate the safety and tolerability of AX-158 in patients with mild to moderate Psoriasis. Participants will be randomized 2:1 to receive AX-158 or Placebo. A total of 30 participants will be treated for 28 days and followed for an additional 30 days for safety.

Being tested
AX-158, Placebo
Medical subject headings
Psoriasis

What participants receive

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

  • AX-158Drug

    Subjects randomized to this arm will receive AX-158 treatment for 28 days with a 30 day safety follow-up period.

  • PlaceboDrug

    Subjects randomized to this arm will receive placebo treatment for 28 days with a 30 day safety follow-up period.

Study groups in NCT05725057
Study groupRoleWhat they receive
AX-158 - (Arm 1)Active comparatorAX-158 Dosage:5 mg capsules Form: Capsule Frequency - 2 capsules daily taken orally Duration - 28 consecutive days
Receives: Drug: AX-158
Placebo - (Arm 2)Placebo comparatorPlacebo Dosage: NA Form: Capsule Frequency: 2 capsules daily taken orally Duration: 28 consecutive days
Receives: Drug: Placebo

What is being measured

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

  1. Treatment-Emergent Adverse Events

    The frequency of treatment-emergent adverse events (TEAEs) either started after initial treatment or intensified in severity

    Measured: Baseline to 28 days of treatment

Secondary outcomes (6)

  1. Psoriasis Area and Severity Index (PASI) -25

    Proportion of subjects receiving AX-158 compared to placebo with PASI 25

    Measured: Baseline to 28 days of treatment

  2. Psoriasis Area and Severity Index (PASI) -50

    Proportion of subjects receiving AX-158 compared to placebo with PASI 50

    Measured: Baseline to 28 days of treatment

  3. Psoriasis Area and Severity Index (PASI) -75

    Proportion of subjects receiving AX-158 compared to placebo with PASI 75

    Measured: Baseline to 28 days of treatment

  4. Psoriasis Area and Severity Index (PASI) - 100

    Proportion of subjects receiving AX-158 compared to placebo with PASI 100

    Measured: Baseline to 28 days of treatment

  5. Biomarkers

    Change from baseline in histological markers of psoriasis in skin biopsies.

    Measured: Baseline to 28 days of treatment

  6. Static Physician Global Assessment (sPGA)

    Proportion of patients receiving AX-158 compared to placebo who achieve sPGA score of 0 or 1

    Measured: Baseline to 28 days of treatment

Timeline

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

  1. First posted13 Feb 2023
  2. Study start30 Nov 2023
  3. Primary completion4 Sep 2024
  4. Study completion4 Oct 2024

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05725057
Sponsor's protocol ID
AX-158-1011
Status last verified
Sep 2025
First submitted
26 Jan 2023
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Borroto A, Reyes-Garau D, Jimenez MA, Carrasco E, Moreno B, Martinez-Pasamar S, Cortes JR, Perona A, Abia D, Blanco S, Fuentes M, Arellano I, Lobo J, Heidarieh H, Rueda J, Esteve P, Cibrian D, Martinez-Riano A, Mendoza P, Prieto C, Calleja E, Oeste CL, Orfao A, Fresno M, Sanchez-Madrid F, Alcami A, Bovolenta P, Martin P, Villoslada P, Morreale A, Messeguer A, Alarcon B. First-in-class inhibitor of the T cell receptor for the treatment of autoimmune diseases. Sci Transl Med. 2016 Dec 21;8(370):370ra184. doi: 10.1126/scitranslmed.aaf2140.

    PubMed 28003549

  • Roy E, Togbe D, Holdorf AD, Trubetskoy D, Nabti S, Kublbeck G, Klevenz A, Kopp-Schneider A, Leithauser F, Moller P, Bladt F, Hammerling G, Arnold B, Pawson T, Tafuri A. Nck adaptors are positive regulators of the size and sensitivity of the T-cell repertoire. Proc Natl Acad Sci U S A. 2010 Aug 31;107(35):15529-34. doi: 10.1073/pnas.1009743107. Epub 2010 Aug 13.

    PubMed 20709959

  • Roy E, Togbe D, Holdorf A, Trubetskoy D, Nabti S, Kublbeck G, Schmitt S, Kopp-Schneider A, Leithauser F, Moller P, Bladt F, Hammerling GJ, Arnold B, Pawson T, Tafuri A. Fine tuning of the threshold of T cell selection by the Nck adapters. J Immunol. 2010 Dec 15;185(12):7518-26. doi: 10.4049/jimmunol.1000008. Epub 2010 Nov 15.

    PubMed 21078909

  • Gil D, Schamel WW, Montoya M, Sanchez-Madrid F, Alarcon B. Recruitment of Nck by CD3 epsilon reveals a ligand-induced conformational change essential for T cell receptor signaling and synapse formation. Cell. 2002 Jun 28;109(7):901-12. doi: 10.1016/s0092-8674(02)00799-7.

    PubMed 12110186

  • Juraske C, Wipa P, Morath A, Hidalgo JV, Hartl FA, Raute K, Oberg HH, Wesch D, Fisch P, Minguet S, Pongcharoen S, Schamel WW. Anti-CD3 Fab Fragments Enhance Tumor Killing by Human gammadelta T Cells Independent of Nck Recruitment to the gammadelta T Cell Antigen Receptor. Front Immunol. 2018 Jul 9;9:1579. doi: 10.3389/fimmu.2018.01579. eCollection 2018.

    PubMed 30038626

  • Borroto A, Arellano I, Blanco R, Fuentes M, Orfao A, Dopfer EP, Prouza M, Suchanek M, Schamel WW, Alarcon B. Relevance of Nck-CD3 epsilon interaction for T cell activation in vivo. J Immunol. 2014 Mar 1;192(5):2042-53. doi: 10.4049/jimmunol.1203414. Epub 2014 Jan 27.

    PubMed 24470497

  • Borroto A, Arellano I, Dopfer EP, Prouza M, Suchanek M, Fuentes M, Orfao A, Schamel WW, Alarcon B. Nck recruitment to the TCR required for ZAP70 activation during thymic development. J Immunol. 2013 Feb 1;190(3):1103-12. doi: 10.4049/jimmunol.1202055. Epub 2012 Dec 24.

    PubMed 23267019

  • Lettau M, Pieper J, Gerneth A, Lengl-Janssen B, Voss M, Linkermann A, Schmidt H, Gelhaus C, Leippe M, Kabelitz D, Janssen O. The adapter protein Nck: role of individual SH3 and SH2 binding modules for protein interactions in T lymphocytes. Protein Sci. 2010 Apr;19(4):658-69. doi: 10.1002/pro.334.

    PubMed 20082308

  • Yiemwattana I, Ngoenkam J, Paensuwan P, Kriangkrai R, Chuenjitkuntaworn B, Pongcharoen S. Essential role of the adaptor protein Nck1 in Jurkat T cell activation and function. Clin Exp Immunol. 2012 Jan;167(1):99-107. doi: 10.1111/j.1365-2249.2011.04494.x.

    PubMed 22132889

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AX-158 in people with Psoriasis and Plaque Psoriasis, run by Artax Biopharma Inc at 6 sites in United Kingdom.

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 15 inclusion and 31 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 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Treatment-Emergent Adverse Events (time frame: Baseline to 28 days of treatment). 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 NCT05725057, which also lists 9 linked publications.

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 Oct 2025.

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