Immunology Areas of Interest

Compounds with areas of interest for Externally Sponsored Research are listed below. We aren’t accepting proposals at this time for the non-listed compounds.

Submissions are aligned to quarterly portal cut‑offs, with applications reviewed by intake cycle.

Brand or Substance	Submissions being Considered	Areas of Interest
IMAAVY™ (nipocalimab-aahu)	Portal open	Generalized Myasthenia Gravis Earlier diagnosis and earlier use of advanced treatments Predictors of therapeutic response (including pre-clinical) Treatment sequencing Treatment outcomes in populations not included in the phase 3 program Steroid reduction Treatment outcomes in comorbid autoimmune-mediated conditions

Brand or Substance

Submissions being Considered

Areas of Interest

IMAAVY™ (nipocalimab-aahu)

Portal open

Generalized Myasthenia Gravis

Earlier diagnosis and earlier use of advanced treatments
Predictors of therapeutic response (including pre-clinical)
Treatment sequencing
Treatment outcomes in populations not included in the phase 3 program
Steroid reduction
Treatment outcomes in comorbid autoimmune-mediated conditions

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Brand or Substance	Submissions being Considered	Areas of Interest
ICOTYDE™ (icotrokinra)	Portal open	Psoriatic Disease Evaluate the impact of ICO on understudied psoriatic disease subpopulations or psoriatic-disease associated comorbidities Evaluate the impact of ICO on other types of PsO, or dermatologic diseases where blocking IL-23 pathway is of scientific rationale Understanding treatment pattern, sequencing, compliance, adherence and persistence and outcomes of ICO in PsO in real-world pragmatic trial setting Understanding mechanism of action or biomarker predictive or response/prognosis of ICO Investigating emerging technologies for disease diagnosis, monitoring, treatment adherence and response Understanding disease burden and unmet needs of PsO

Brand or Substance

Submissions being Considered

Areas of Interest

ICOTYDE™ (icotrokinra)

Portal open

Psoriatic Disease

Evaluate the impact of ICO on understudied psoriatic disease subpopulations or psoriatic-disease associated comorbidities
Evaluate the impact of ICO on other types of PsO, or dermatologic diseases where blocking IL-23 pathway is of scientific rationale
Understanding treatment pattern, sequencing, compliance, adherence and persistence and outcomes of ICO in PsO in real-world pragmatic trial setting
Understanding mechanism of action or biomarker predictive or response/prognosis of ICO
Investigating emerging technologies for disease diagnosis, monitoring, treatment adherence and response
Understanding disease burden and unmet needs of PsO

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Brand or Substance	Submissions being Considered	Areas of Interest
TREMFYA® (guselkumab) - IBD	Portal open	Inflammatory Bowel Disease: CD & UC Advanced treatment sequencing including biologics and small molecules Switching, optimizing, real world usage, alternate dosing strategies Treatment outcomes in advanced therapy failures, line of therapy, etc. Methods of overcoming barriers to biologic initiation, including treatment paradigms, and physician and patient perceptions. Treatment outcomes in special populations Post op CD (POCD), fibro-stenotic patients, etc Patient-reported outcomes Tenesmus, fecal incontinence, nocturnal bowel movements, sleep interruption, bowel urgency, etc. Novel and impactful new modalities to assess treatment response Additional Disease States of Interest Impact on diverse populations Treatment journey and disease manifestations Treatment outcomes in special populations Elderly, pouch, microscopic colitis, proctitis, obesity, EIMs, etc Treatment outcomes in comorbid immune-medicated conditions (e.g., PsO, PsA, etc)

Brand or Substance

Submissions being Considered

Areas of Interest

TREMFYA® (guselkumab) - IBD

Portal open

Inflammatory Bowel Disease: CD & UC

Advanced treatment sequencing including biologics and small molecules
- Switching, optimizing, real world usage, alternate dosing strategies
- Treatment outcomes in advanced therapy failures, line of therapy, etc.
Methods of overcoming barriers to biologic initiation, including treatment paradigms, and physician and patient perceptions.
Treatment outcomes in special populations
- Post op CD (POCD), fibro-stenotic patients, etc
Patient-reported outcomes
- Tenesmus, fecal incontinence, nocturnal bowel movements, sleep interruption, bowel urgency, etc.
Novel and impactful new modalities to assess treatment response

Additional Disease States of Interest

Impact on diverse populations
- Treatment journey and disease manifestations
Treatment outcomes in special populations
- Elderly, pouch, microscopic colitis, proctitis, obesity, EIMs, etc
Treatment outcomes in comorbid immune-medicated conditions (e.g., PsO, PsA, etc)

Click here to make a submission

Brand or Substance	Submissions being Considered	Areas of Interest
TREMFYA® (guselkumab) - Psoriatic Disease	Portal open	Psoriasis Advancing  research and innovations in patients with skin of color Early diagnosis and treatment/prevention of disease progression strategies RWE generation aimed at differentiating among biologics focusing on durability, dosing, clearance, treatment patterns (biologic-naïve, biologic-experienced, switch) Changing the treatment paradigm for low body surface area involvement with high impact PsO (e.g., low BSA with moderate disease special sites PsO) Additional Disease States Areas of Interest Proposals will be evaluated on a case-by-case basis: Lichen planus (LP) Cicatricial Alopecia Darier disease (DD) Pemphigus Cutaneous forms of lupus erythematosus Sebopsoriasis Psoriatic Arthritis Treatment outcomes across the specific domains of psoriatic disease Early diagnosis and treatment/prevention of disease progression strategies Predictors of therapeutic response, including use of biomarkers Pragmatic/real-world data generation around burden of disease, treatment patterns (e.g., biologic switching/sequencing), as well as implementation of treatment recommendation strategies (i.e., T2T (treat-to-target)) to achieve low disease activity/remission in patients) Novel imaging modalities examining treatment impact on peripheral, soft tissue, and/or axial domains of disease Treatment effects on associated extra-articular manifestations/comorbidities, (e.g., uveitis, inflammatory bowel disease)

Brand or Substance

Submissions being Considered

Areas of Interest

TREMFYA® (guselkumab) - Psoriatic Disease

Portal open

Psoriasis

Advancing  research and innovations in patients with skin of color
Early diagnosis and treatment/prevention of disease progression strategies
RWE generation aimed at differentiating among biologics focusing on durability, dosing, clearance, treatment patterns (biologic-naïve, biologic-experienced, switch)
Changing the treatment paradigm for low body surface area involvement with high impact PsO (e.g., low BSA with moderate disease special sites PsO)

Additional Disease States Areas of Interest
Proposals will be evaluated on a case-by-case basis:

Lichen planus (LP)
Cicatricial Alopecia
Darier disease (DD)
Pemphigus
Cutaneous forms of lupus erythematosus
Sebopsoriasis

Psoriatic Arthritis

Treatment outcomes across the specific domains of psoriatic disease
Early diagnosis and treatment/prevention of disease progression strategies
Predictors of therapeutic response, including use of biomarkers
Pragmatic/real-world data generation around burden of disease, treatment patterns (e.g., biologic switching/sequencing), as well as implementation of treatment recommendation strategies (i.e., T2T (treat-to-target)) to achieve low disease activity/remission in patients)
Novel imaging modalities examining treatment impact on peripheral, soft tissue, and/or axial domains of disease
Treatment effects on associated extra-articular manifestations/comorbidities, (e.g., uveitis, inflammatory bowel disease)

Click here to make a submission